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Randomized, Open-label Phase II Trial to Assess the Safety and Immunogenicity of MVA-BN Smallpox Vaccine in Immunocompromised Subjects With HIV Infection

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02038881
Recruitment Status : Completed
First Posted : January 17, 2014
Results First Posted : April 2, 2020
Last Update Posted : April 2, 2020
Sponsor:
Information provided by (Responsible Party):
Bavarian Nordic

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Prevention
Condition Smallpox
Intervention Biological: IMVAMUNE®
Enrollment 87
Recruitment Details Subjects were screened and enrolled at 12 sites in the US
Pre-assignment Details  
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Period Title: Overall Study
Started 27 29 31
Completed 24 29 30
Not Completed 3 0 1
Reason Not Completed
Withdrawal by Subject             0             0             1
Lost to Follow-up             2             0             0
incarcerated             1             0             0
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen) Total
Hide Arm/Group Description

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Total of all reporting groups
Overall Number of Baseline Participants 27 29 31 87
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 27 participants 29 participants 31 participants 87 participants
35.1  (7.66) 33.1  (6.67) 36.6  (5.43) 35  (6.68)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 29 participants 31 participants 87 participants
Female
4
  14.8%
5
  17.2%
3
   9.7%
12
  13.8%
Male
23
  85.2%
24
  82.8%
28
  90.3%
75
  86.2%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 27 participants 29 participants 31 participants 87 participants
American Indian or Alaskan Native
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Oriental/Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black/African American
16
  59.3%
18
  62.1%
16
  51.6%
50
  57.5%
Native Hawaiian/Other Pacific Islander
0
   0.0%
0
   0.0%
1
   3.2%
1
   1.1%
White/Caucasian
10
  37.0%
10
  34.5%
14
  45.2%
34
  39.1%
Other
1
   3.7%
1
   3.4%
0
   0.0%
2
   2.3%
Hispanic or Latino
5
  18.5%
4
  13.8%
3
   9.7%
12
  13.8%
Not Hispanic or Latino
22
  81.5%
25
  86.2%
28
  90.3%
75
  86.2%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 27 participants 29 participants 31 participants 87 participants
27 29 31 87
1.Primary Outcome
Title Number of Participants With SAEs
Hide Description Occurrence, relationship and intensity of any serious AE (SAE)
Time Frame within 75 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 27 29 31
Measure Type: Count of Participants
Unit of Measure: Participants
Any SAE
0
   0.0%
0
   0.0%
2
   6.5%
Any SAE with intensity >= Grade 3
0
   0.0%
0
   0.0%
2
   6.5%
Any SAE assessed as related to vaccine
0
   0.0%
0
   0.0%
0
   0.0%
2.Secondary Outcome
Title Number of Participants With AESIs
Hide Description Occurrence, relationship to the trial vaccine, and intensity of any adverse event of special interest (AESI)
Time Frame within 75 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 27 29 31
Measure Type: Count of Participants
Unit of Measure: Participants
Any AESI
0
   0.0%
0
   0.0%
1
   3.2%
Any AESI with intensity >= Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
Any AESI assessed as related to vaccine
0
   0.0%
0
   0.0%
0
   0.0%
3.Secondary Outcome
Title Number of Participants With Related Grade >=3 Adverse Events
Hide Description Number of Participants with any Grade >=3 Adverse Event probably, possibly, or definitely related to the study vaccine. Pooled solicited and unsolicited AEs.
Time Frame within 29 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 27 29 31
Measure Type: Count of Participants
Unit of Measure: Participants
4
  14.8%
5
  17.2%
3
   9.7%
4.Secondary Outcome
Title Number of Unsolicited Non-serious Adverse Events: Relationship to Vaccination
Hide Description Occurrence of unsolicited non-serious AEs by relationship to study vaccine
Time Frame within 29 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 27 29 31
Measure Type: Number
Unit of Measure: events
Unrelated/None 4 4 13
Unlikely 1 2 1
Possible 1 1 0
Probable 0 0 1
Definite 0 0 0
5.Secondary Outcome
Title Number of Unsolicited Non-serious Adverse Events: Intensity
Hide Description Occurrence of unsolicited non-serious AEs by Intensity
Time Frame within 29 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 27 29 31
Measure Type: Number
Unit of Measure: events
Mild 4 7 9
Moderate 1 0 6
Severe 1 0 0
6.Secondary Outcome
Title Number of Participants With Solicited Local Adverse Events
Hide Description Number of participants with solicited local AEs (redness, swelling, induration, pruritus, and pain) by intensity. Percentages based on subjects with at least one completed diary card. [Injection site erythema, injection site swelling and injection site induration--all sizes measured in diameter with max severity of: 0=0, 1 = <30 mm, 2 = ≥30 - <100 mm, 3 = ≥100 mm. Injection site pruritus: 0=absent, 1=mild, 2=moderate, 3=severe. Injection site pain: 0=absent, 1=painful to touch, 2=painful when limb is moved, 3=spontaneously painful/prevents normal activity.]
Time Frame within 8 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 27 29 31
Measure Type: Count of Participants
Unit of Measure: Participants
Injection Site Pain, Grade 1
5
  18.5%
4
  13.8%
11
  35.5%
Injection Site Pain, Grade 2
10
  37.0%
11
  37.9%
10
  32.3%
Injection Site Pain, Grade 3
2
   7.4%
4
  13.8%
1
   3.2%
Injection Site Erythema, Grade 1
7
  25.9%
11
  37.9%
15
  48.4%
Injection Site Erythema, Grade 2
1
   3.7%
0
   0.0%
3
   9.7%
Injection Site Erythema, Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
Injection Site Swelling, Grade 1
9
  33.3%
9
  31.0%
9
  29.0%
Injection Site Swelling, Grade 2
1
   3.7%
1
   3.4%
4
  12.9%
Injection Site Swelling, Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
Injection Site Induration, Grade 1
7
  25.9%
5
  17.2%
9
  29.0%
Injection Site Induration, Grade 2
1
   3.7%
1
   3.4%
1
   3.2%
Injection Site Induration, Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
Injection Site Pruritus, Grade 1
7
  25.9%
6
  20.7%
15
  48.4%
Injection Site Pruritus, Grade 2
4
  14.8%
2
   6.9%
3
   9.7%
Injection Site Pruritus, Grade 3
1
   3.7%
0
   0.0%
0
   0.0%
7.Secondary Outcome
Title Number of Participants With Solicited General AEs
Hide Description Number of Participants with solicited systemic/general AEs (pyrexia, headache, myalgia, nausea, fatigue, and chills) by intensity. Percentages based on subjects with at least one completed diary card. [Body temperature: 0 = <99.5 F (<37.5 C), 1 = ≥99.5 - <100.4 F (≥37.5 - <38.0 C), 2= ≥100.4 - <102.2 F (≥38.0 - <39.0 C), 3= ≥102.2 - <104.0 F (≥39.0 - <40.0 C), 4= ≥ 104.0 F (≥40.0 C); pyrexia is defined as oral temperature ≥ 100.4 F (≥ 38.0 C).] [Headache, myalgia, nausea, chills and fatigue: 0 = none, 1 = mild: easily tolerated, minimal discomfort and no interference with daily activity, 2 = moderate: some interference with daily activity, 3 = severe: prevents daily activity.]
Time Frame within 8 days after any vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 27 29 31
Measure Type: Count of Participants
Unit of Measure: Participants
Pyrexia, Grade 1
0
   0.0%
0
   0.0%
0
   0.0%
Pyrexia, Grade 2
1
   3.7%
0
   0.0%
0
   0.0%
Pyrexia, Grade 3
0
   0.0%
0
   0.0%
0
   0.0%
Headache, Grade 1
8
  29.6%
5
  17.2%
6
  19.4%
Headache, Grade 2
1
   3.7%
3
  10.3%
3
   9.7%
Headache, Grade 3
0
   0.0%
2
   6.9%
1
   3.2%
Myalgia, Grade 1
6
  22.2%
6
  20.7%
8
  25.8%
Myalgia, Grade 2
2
   7.4%
6
  20.7%
4
  12.9%
Myalgia, Grade 3
1
   3.7%
0
   0.0%
1
   3.2%
Chills, Grade 1
4
  14.8%
4
  13.8%
5
  16.1%
Chills, Grade 2
2
   7.4%
2
   6.9%
1
   3.2%
Chills, Grade 3
1
   3.7%
0
   0.0%
0
   0.0%
Nausea, Grade 1
3
  11.1%
4
  13.8%
4
  12.9%
Nausea, Grade 2
3
  11.1%
0
   0.0%
2
   6.5%
Nausea, Grade 3
0
   0.0%
2
   6.9%
0
   0.0%
Fatigue, Grade 1
5
  18.5%
4
  13.8%
5
  16.1%
Fatigue, Grade 2
2
   7.4%
5
  17.2%
5
  16.1%
Fatigue, Grade 3
2
   7.4%
2
   6.9%
1
   3.2%
8.Secondary Outcome
Title CD4+ T Cell Counts
Hide Description Mean CD4+ T-cell counts over time
Time Frame within 15 days after each vaccination
Hide Outcome Measure Data
Hide Analysis Population Description
Full Analysis Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 27 29 31
Mean (Standard Deviation)
Unit of Measure: CD4 count (cells/µL)
Screening 304.9  (104.77) 295.3  (111.10) 349.6  (133.71)
Week 2 337.4  (118.18) 357.0  (157.87) 335.7  (111.11)
Week 6 319.1  (117.91) 365.4  (197.04) 345.0  (96.22)
Week 14 NA [1]   (NA) NA [2]   (NA) 351.9  (114.53)
[1]
N/A=week 14 visit not scheduled for Group 1
[2]
N/A=week 14 visit not scheduled for Group 2
9.Secondary Outcome
Title Geometric Mean Titers (GMT) Measured by Enzyme-linked Immunosorbent Assay (ELISA) at All Immunogenicity Sampling Points
Hide Description GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
Time Frame within 64 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 20 23 26
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Week 0
1.5
(0.8 to 2.6)
1.2
(0.8 to 1.7)
1.8
(0.9 to 3.5)
Week 4
40.0
(15.3 to 105.1)
47.1
(20.7 to 107.1)
41.8
(16.2 to 107.8)
Week 6
552.2
(337.1 to 904.4)
846.1
(475.3 to 1506.1)
726.1
(371.3 to 1419.8)
Week 12
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
193.1
(90.9 to 410.5)
Week 14
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
1591.2
(1158.1 to 2186.3)
Week 30/38
34.6
(12.2 to 98.5)
30.8
(11.3 to 83.5)
143.3
(67.6 to 303.9)
Week 56/64
25.2
(8.4 to 75.7)
27.5
(9.6 to 79.2)
116.2
(57.9 to 233.2)
[1]
N/A=week 12 and 14 visits not scheduled for Group 1
[2]
N/A=week 12 and 14 visits not scheduled for Group 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 1 / Group 2) at Week 4
Estimated Value 0.851
Confidence Interval (2-Sided) 95%
0.258 to 2.800
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 1 / Group 2) at Week 6
Estimated Value 0.653
Confidence Interval (2-Sided) 95%
0.319 to 1.333
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 1 / Group 2) at Week 30
Estimated Value 1.126
Confidence Interval (2-Sided) 95%
0.291 to 4.352
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 1 / Group 2) at Week 56
Estimated Value 0.916
Confidence Interval (2-Sided) 95%
0.220 to 3.819
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 3 / Group 1) at Week 4
Estimated Value 1.045
Confidence Interval (2-Sided) 95%
0.292 to 3.741
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 3 / Group 1) at Week 6
Estimated Value 1.315
Confidence Interval (2-Sided) 95%
0.598 to 2.892
Estimation Comments [Not Specified]
10.Secondary Outcome
Title ELISA GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
Hide Description GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 and 3 Combined Group 2
Hide Arm/Group Description:
Pooling of Groups 1 and 3 (same dose/regimen before booster vaccination in Group 3)
Double dose regimen
Overall Number of Participants Analyzed 46 23
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
644.6
(422.7 to 983.0)
846.1
(475.3 to 1506.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 and 3 Combined, Group 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 1+3 [pooled] / Group 2)
Estimated Value 0.762
Confidence Interval (2-Sided) 95%
0.385 to 1.507
Estimation Comments [Not Specified]
11.Secondary Outcome
Title ELISA GMT 2 Weeks Following the Last Vaccination
Hide Description GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'.
Time Frame Week 6 (Groups 1 and 2), Week 14 (Group 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 20 23 26
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
552.2
(337.1 to 904.4)
846.1
(475.3 to 1506.1)
1591.2
(1158.1 to 2186.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 1 [W6]/ Group 3 [W14)
Estimated Value 0.347
Confidence Interval (2-Sided) 95%
0.200 to 0.603
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2 (Double Dose Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (Group 2 [W6]/ Group 3 [W14])
Estimated Value 0.532
Confidence Interval (2-Sided) 95%
0.285 to 0.992
Estimation Comments [Not Specified]
12.Secondary Outcome
Title ELISA GMT During Follow-up
Hide Description GMTs based on vaccinia-specific ELISA. Titers below the detection limit are included with a value of '1'. Participants discontinued prior to the follow-up visits are excluded.
Time Frame Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 18 22 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Week 30/38
34.6
(12.2 to 98.5)
30.8
(11.3 to 83.5)
143.3
(67.6 to 303.9)
Week 56/64
25.2
(8.4 to 75.7)
27.5
(9.6 to 79.2)
116.2
(57.9 to 233.2)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 3 [W38]/ Group 1 [W30])
Estimated Value 4.138
Confidence Interval (2-Sided) 95%
1.241 to 13.793
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 3 [W64]/ Group 1 [W56])
Estimated Value 4.608
Confidence Interval (2-Sided) 95%
1.365 to 15.558
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 2 (Double Dose Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 2 [W30]/ Group 3 [W38])
Estimated Value 0.215
Confidence Interval (2-Sided) 95%
0.066 to 0.699
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 2 (Double Dose Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 2 [W56]/ Group 3 [W64])
Estimated Value 0.237
Confidence Interval (2-Sided) 95%
0.072 to 0.782
Estimation Comments [Not Specified]
13.Secondary Outcome
Title GMTs Measured by Plaque Reduction Neutralization Test (PRNT) at All Immunogenicity Sampling Points
Hide Description GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
Time Frame within 64 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 20 23 26
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Week 0
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
1.2
(0.8 to 1.9)
Week 4
3.9
(1.9 to 8.1)
4.8
(2.5 to 9.2)
10.1
(4.8 to 21.1)
Week 6
78.9
(49.9 to 124.8)
100.3
(59.8 to 168.4)
95.9
(54.6 to 168.3)
Week 12
NA [2] 
(NA to NA)
NA [3] 
(NA to NA)
35.5
(19.6 to 64.5)
Week 14
NA [2] 
(NA to NA)
NA [3] 
(NA to NA)
281.1
(166.6 to 474.1)
Week 30/38
6.2
(2.6 to 14.8)
11.5
(5.6 to 23.5)
41.5
(22.6 to 75.9)
Week 56/64
6.2
(2.5 to 15.4)
10.6
(5.3 to 21.2)
45.3
(26.0 to 79.0)
[1]
None of the participants have titer values above the detection limit.
[2]
N/A=week 12 and 14 visits not scheduled for Group 1
[3]
N/A=week 12 and 14 visits not scheduled for Group 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 1 / Group 2) at Week 4
Estimated Value 0.823
Confidence Interval (2-Sided) 95%
0.333 to 2.038
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 1 / Group 2) at Week 6
Estimated Value 0.787
Confidence Interval (2-Sided) 95%
0.410 to 1.508
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 1 / Group 2) at Week 30
Estimated Value 0.535
Confidence Interval (2-Sided) 95%
0.187 to 1.536
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 1 / Group 2) at Week 56
Estimated Value 0.590
Confidence Interval (2-Sided) 95%
0.203 to 1.716
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 3 / Group 1) at Week 4
Estimated Value 2.557
Confidence Interval (2-Sided) 95%
0.972 to 6.731
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 3 / Group 1) at Week 6
Estimated Value 1.215
Confidence Interval (2-Sided) 95%
0.612 to 2.412
Estimation Comments [Not Specified]
14.Secondary Outcome
Title PRNT GMT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
Hide Description GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 and 3 Combined Group 2
Hide Arm/Group Description:
Pooling of Groups 1 and 3 (same dose/regimen before booster vaccination in Group 3)
Double dose regimen
Overall Number of Participants Analyzed 46 23
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
88.1
(61.3 to 126.6)
100.3
(59.8 to 168.4)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 and 3 Combined, Group 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 1+3 [pooled] / Group 2)
Estimated Value 0.878
Confidence Interval (2-Sided) 95%
0.480 to 1.606
Estimation Comments [Not Specified]
15.Secondary Outcome
Title PRNT GMT 2 Weeks Following the Last Vaccination
Hide Description GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'.
Time Frame Week 6 (Groups 1 and 2), Week 14 (Group 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 20 23 26
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
78.9
(49.9 to 124.8)
100.3
(59.8 to 168.4)
281.1
(166.6 to 474.1)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (Group 1 [W6]/ Group 3 [W14)
Estimated Value 0.281
Confidence Interval (2-Sided) 95%
0.146 to 0.542
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2 (Double Dose Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT ratio (Group 2 [W6]/ Group 3 [W14])
Estimated Value 0.357
Confidence Interval (2-Sided) 95%
0.178 to 0.718
Estimation Comments [Not Specified]
16.Secondary Outcome
Title PRNT GMT During Follow-up
Hide Description GMTs based on vaccinia-specific PRNT. Titers below the detection limit are included with a value of '1'. Participants discontinued prior to the follow-up visits are excluded.
Time Frame Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 18 22 24
Geometric Mean (95% Confidence Interval)
Unit of Measure: Titer
Week 30/38
6.2
(2.6 to 14.8)
11.5
(5.6 to 23.5)
41.5
(22.6 to 75.9)
Week 56/64
6.2
(2.5 to 15.4)
10.6
(5.3 to 21.2)
45.3
(26.0 to 79.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 3 [W38]/ Group 1 [W30])
Estimated Value 6.727
Confidence Interval (2-Sided) 95%
2.493 to 18.150
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 3 [W64]/ Group 1 [W56])
Estimated Value 7.275
Confidence Interval (2-Sided) 95%
2.693 to 19.649
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 2 (Double Dose Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 2 [W30]/ Group 3 [W38])
Estimated Value 0.278
Confidence Interval (2-Sided) 95%
0.115 to 0.672
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 2 (Double Dose Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter GMT Ratio (Group 2 [W56]/ Group 3 [W64])
Estimated Value 0.233
Confidence Interval (2-Sided) 95%
0.100 to 0.541
Estimation Comments [Not Specified]
17.Secondary Outcome
Title Percentage of Participants With Seroconversion by ELISA
Hide Description SC rate based on ELISA. SC is defined as the appearance of antibody titers >= detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame within 64 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 20 23 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Week 4 Number Analyzed 20 participants 23 participants 26 participants
75.0
(50.9 to 91.3)
82.6
(61.2 to 95.0)
69.2
(48.2 to 85.7)
Week 6 Number Analyzed 20 participants 23 participants 26 participants
100.0
(83.2 to 100.0)
100.0
(85.2 to 100.0)
92.3
(74.9 to 99.1)
Week 12 Number Analyzed 20 participants 23 participants 26 participants
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
84.6
(65.1 to 95.6)
Week 14 Number Analyzed 20 participants 23 participants 26 participants
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
100.0
(86.8 to 100.0)
Week 30/38 Number Analyzed 18 participants 22 participants 24 participants
77.8
(52.4 to 93.6)
72.7
(49.8 to 89.3)
83.3
(62.6 to 95.3)
Week 56/64 Number Analyzed 18 participants 22 participants 24 participants
66.7
(41.0 to 86.7)
68.2
(45.1 to 86.1)
83.3
(62.6 to 95.3)
[1]
N/A=week 12 and 14 visits not scheduled for Group 1
[2]
N/A=week 12 and 14 visits not scheduled for Group 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 1 - Gr 2) at Week 4
Estimated Value -7.6
Confidence Interval (2-Sided) 95%
-34.1 to 17.9
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 1 - Gr 2) at Week 6
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-16.8 to 16.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 1 - Gr 2) at Week 30
Estimated Value 5.1
Confidence Interval (2-Sided) 95%
-24.5 to 32.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 1 - Gr 2) at Week 56
Estimated Value -1.5
Confidence Interval (2-Sided) 95%
-31.5 to 29.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 3 - Gr 1) at Week 4
Estimated Value -5.8
Confidence Interval (2-Sided) 95%
-32.8 to 22.2
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 3 - Gr 1) at Week 6
Estimated Value -7.7
Confidence Interval (2-Sided) 95%
-25.1 to 10.1
Estimation Comments [Not Specified]
18.Secondary Outcome
Title Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
Hide Description SC rate based on ELISA. SC is defined as the appearance of antibody titers >= detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 and 3 Combined Group 2
Hide Arm/Group Description:
Pooling of Groups 1 and 3 (same dose/regimen before booster vaccination in Group 3)
Double dose regimen
Overall Number of Participants Analyzed 46 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
95.7
(85.2 to 99.5)
100.0
(85.2 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 and 3 Combined, Group 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in seroconversion rates (%)
Estimated Value -4.3
Confidence Interval (2-Sided) 95%
-15.2 to 11.6
Estimation Comments [Not Specified]
19.Secondary Outcome
Title Percentage of Participants With Seroconversion by ELISA 2 Weeks Following the Last Vaccination
Hide Description SC rate based on ELISA. SC is defined as the appearance of antibody titers >= detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame Week 6 (Groups 1 and 2), Week 14 (Group 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 20 23 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
100.0
(83.2 to 100.0)
100.0
(85.2 to 100.0)
100.0
(86.8 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-17.1 to 13.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2 (Double Dose Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-16.2 to 13.4
Estimation Comments [Not Specified]
20.Secondary Outcome
Title Percentage of Participants With Seroconversion by ELISA During Follow-up
Hide Description SC rate based on ELISA. SC is defined as the appearance of antibody titers >= detection limit (50) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 18 22 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Week 30/38
77.8
(52.4 to 93.6)
72.7
(49.8 to 89.3)
83.3
(62.6 to 95.3)
Week 56/64
66.7
(41.0 to 86.7)
68.2
(45.1 to 86.1)
83.3
(62.6 to 95.3)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr3 [W38] - Gr1 [W30])
Estimated Value 5.6
Confidence Interval (2-Sided) 95%
-19.6 to 33.0
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr3 [W64] - Gr1 [W56])
Estimated Value 16.7
Confidence Interval (2-Sided) 95%
-11.0 to 44.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 2 (Double Dose Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr2 [W30] - Gr3 [W38])
Estimated Value -10.6
Confidence Interval (2-Sided) 95%
-35.6 to 14.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 2 (Double Dose Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr2 [W56] - Gr3 [W64])
Estimated Value -15.2
Confidence Interval (2-Sided) 95%
-40.5 to 10.5
Estimation Comments [Not Specified]
21.Secondary Outcome
Title Percentage of Participants With Seroconversion by PRNT
Hide Description SC rate based on PRNT. SC is defined as the appearance of antibody titers >= detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame within 64 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 20 23 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Week 4 Number Analyzed 20 participants 23 participants 26 participants
60.0
(36.1 to 80.9)
69.6
(47.1 to 86.8)
80.8
(60.6 to 93.4)
Week 6 Number Analyzed 20 participants 23 participants 26 participants
100.0
(83.2 to 100.0)
100.0
(85.2 to 100.0)
96.2
(80.4 to 99.9)
Week 12 Number Analyzed 20 participants 23 participants 26 participants
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
96.2
(80.4 to 99.9)
Week 14 Number Analyzed 20 participants 23 participants 26 participants
NA [1] 
(NA to NA)
NA [2] 
(NA to NA)
100.0
(86.8 to 100.0)
Week 30/38 Number Analyzed 18 participants 22 participants 24 participants
72.2
(46.5 to 90.3)
81.8
(59.7 to 94.8)
91.7
(73.0 to 99.0)
Week 56/64 Number Analyzed 18 participants 22 participants 24 participants
66.7
(41.0 to 86.7)
72.7
(49.8 to 89.3)
95.8
(78.9 to 99.9)
[1]
N/A=week 12 and 14 visits not scheduled for Group 1
[2]
N/A=week 12 and 14 visits not scheduled for Group 2
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 1 - Gr 2) at Week 4
Estimated Value -9.6
Confidence Interval (2-Sided) 95%
-38.4 to 20.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 1 - Gr 2) at Week 6
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-16.8 to 16.3
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 1 - Gr 2) at Week 30
Estimated Value -9.6
Confidence Interval (2-Sided) 95%
-38.4 to 17.6
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 2 (Double Dose Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 1 - Gr 2) at Week 56
Estimated Value -6.1
Confidence Interval (2-Sided) 95%
-35.6 to 23.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 3 - Gr 1) at Week 4
Estimated Value 20.8
Confidence Interval (2-Sided) 95%
-7.7 to 47.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 3 - Gr 1) at Week 6
Estimated Value -3.8
Confidence Interval (2-Sided) 95%
-20.5 to 13.4
Estimation Comments [Not Specified]
22.Secondary Outcome
Title Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Second Vaccination (Group 2 Compared to Group 1 and Group 3 (Combined))
Hide Description SC rate based on PRNT. SC is defined as the appearance of antibody titers >= detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame Week 6
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 and 3 Combined Group 2
Hide Arm/Group Description:
Pooling of Groups 1 and 3 (same dose/regimen before booster vaccination in Group 3)
Double dose regimen
Overall Number of Participants Analyzed 46 23
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
97.8
(88.5 to 99.9)
100.0
(85.2 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 and 3 Combined, Group 2
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Difference in seroconversion rates (%)
Estimated Value -2.2
Confidence Interval (2-Sided) 95%
-12.0 to 13.2
Estimation Comments [Not Specified]
23.Secondary Outcome
Title Percentage of Participants With Seroconversion by PRNT 2 Weeks Following the Last Vaccination
Hide Description SC rate based on PRNT. SC is defined as the appearance of antibody titers >= detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame Week 6 (Groups 1 and 2), Week 14 (Group 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 20 23 26
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
100.0
(83.2 to 100.0)
100.0
(85.2 to 100.0)
100.0
(86.8 to 100.0)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 1 [W6] - Gr 3 [W14])
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-17.1 to 13.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 2 (Double Dose Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr 2 [W6] - Gr 3 [W14])
Estimated Value 0.0
Confidence Interval (2-Sided) 95%
-16.2 to 13.4
Estimation Comments [Not Specified]
24.Secondary Outcome
Title Percentage of Participants With Seroconversion by PRNT During Follow-up
Hide Description SC rate based on PRNT. SC is defined as the appearance of antibody titers >= detection limit (2) for initially seronegative subjects, or a doubling or more of the antibody titer compared to Baseline titer for initially seropositive subjects. Percentages based on number of subjects with data available.
Time Frame Weeks 30 and 56 (Groups 1 and 2), Weeks 38 and 64 (Group 3)
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol Set
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description:

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Overall Number of Participants Analyzed 18 22 24
Measure Type: Number
Number (95% Confidence Interval)
Unit of Measure: percentage of subjects
Week 30/38
72.2
(46.5 to 90.3)
81.8
(59.7 to 94.8)
91.7
(73.0 to 99.0)
Week 56/64
66.7
(41.0 to 86.7)
72.7
(49.8 to 89.3)
95.8
(78.9 to 99.9)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr3 [W38] - Gr1 [W30])
Estimated Value 19.4
Confidence Interval (2-Sided) 95%
-4.5 to 45.8
Estimation Comments [Not Specified]
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Group 1 (Standard Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr3 [W64] - Gr1 [W56])
Estimated Value 29.2
Confidence Interval (2-Sided) 95%
5.8 to 55.4
Estimation Comments [Not Specified]
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Group 2 (Double Dose Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr2 [W30] - Gr3 [W38])
Estimated Value -9.8
Confidence Interval (2-Sided) 95%
-33.0 to 11.7
Estimation Comments [Not Specified]
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Group 2 (Double Dose Regimen), Group 3 (Booster Regimen)
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Method of Estimation Estimation Parameter Diff in SC rate (Gr2 [W56] - Gr3 [W64])
Estimated Value -23.1
Confidence Interval (2-Sided) 95%
-46.7 to -1.0
Estimation Comments [Not Specified]
Time Frame within 75 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Hide Arm/Group Description

One injection at Day 0 and Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

Two injections at Day 0 and two injections at Day 28 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

One injection at Day 0 and Day 28 and one booster injection at week 12 with IMVAMUNE® (MVA-BN®)

IMVAMUNE®: 0.5 ml Modified Vaccinia Ankara Strain - Bavarian Nordic (MVA-BN®) smallpox vaccine containing at least 1 x 10E8 TCID50 per ml

All-Cause Mortality
Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/27 (0.00%)      0/29 (0.00%)      0/31 (0.00%)    
Hide Serious Adverse Events
Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/27 (0.00%)      0/29 (0.00%)      2/31 (6.45%)    
Gastrointestinal disorders       
Pancreatitis  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
Psychiatric disorders       
Depression  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Group 1 (Standard Regimen) Group 2 (Double Dose Regimen) Group 3 (Booster Regimen)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   5/27 (18.52%)      6/29 (20.69%)      10/31 (32.26%)    
Gastrointestinal disorders       
Inguinal hernia  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
Vomiting  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
General disorders       
Influenza like illness  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
Non-cardiac chest pain  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
Hepatobiliary disorders       
Hyperbilirubinaemia  1  1/27 (3.70%)  1 0/29 (0.00%)  0 0/31 (0.00%)  0
Infections and infestations       
Furuncle  1  1/27 (3.70%)  1 0/29 (0.00%)  0 0/31 (0.00%)  0
Herpes zoster  1  1/27 (3.70%)  1 0/29 (0.00%)  0 0/31 (0.00%)  0
Influenza  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
Rhinitis  1  0/27 (0.00%)  0 1/29 (3.45%)  1 0/31 (0.00%)  0
Skin bacterial infection  1  0/27 (0.00%)  0 1/29 (3.45%)  1 0/31 (0.00%)  0
Upper respiratory tract infection  1  1/27 (3.70%)  1 0/29 (0.00%)  0 0/31 (0.00%)  0
Injury, poisoning and procedural complications       
Human bite  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
Laceration  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
Ulna fracture  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
Investigations       
Blood creatinine increased  1  0/27 (0.00%)  0 1/29 (3.45%)  1 1/31 (3.23%)  1
Troponin I increased  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
Musculoskeletal and connective tissue disorders       
Back pain  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
Myalgia  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
Neck pain  1  0/27 (0.00%)  0 1/29 (3.45%)  1 0/31 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough  1  0/27 (0.00%)  0 1/29 (3.45%)  1 1/31 (3.23%)  1
Nasal congestion  1  0/27 (0.00%)  0 0/29 (0.00%)  0 1/31 (3.23%)  1
Oropharyngeal pain  1  1/27 (3.70%)  1 0/29 (0.00%)  0 0/31 (0.00%)  0
Productive cough  1  0/27 (0.00%)  0 1/29 (3.45%)  1 1/31 (3.23%)  1
Sinus congestion  1  1/27 (3.70%)  1 0/29 (0.00%)  0 0/31 (0.00%)  0
Skin and subcutaneous tissue disorders       
Rash  1  0/27 (0.00%)  0 1/29 (3.45%)  1 0/31 (0.00%)  0
1
Term from vocabulary, MedDRA 20.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Program Lead, Clinical Operations
Organization: Bavarian Nordic A/S
Phone: +45 3326 ext 8383
EMail: info@bavarian-nordic.com
Layout table for additonal information
Responsible Party: Bavarian Nordic
ClinicalTrials.gov Identifier: NCT02038881    
Other Study ID Numbers: POX-MVA-037
First Submitted: January 15, 2014
First Posted: January 17, 2014
Results First Submitted: February 13, 2020
Results First Posted: April 2, 2020
Last Update Posted: April 2, 2020