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Influenza A/H5N1 Vaccine Clinical Trial (IVACFLU-A/H5N1) - Phase 1

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: NCT02171819
Recruitment Status : Completed
First Posted : June 24, 2014
Results First Posted : March 14, 2019
Last Update Posted : March 14, 2019
Sponsor:
Collaborators:
Department of Health and Human Services
World Health Organization
Institut Pasteur
PATH
Information provided by (Responsible Party):
Institute of Vaccines and Medical Biologicals, Vietnam

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Single Group Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Prevention
Condition Influenza A Subtype H5N1 Infection
Interventions Biological: IVACFLU-A/H5N1, 7.5 mcg
Biological: IVACFLU-A/H5N1, 15 mcg
Other: Placebo Comparator
Enrollment 75
Recruitment Details  
Pre-assignment Details  
Arm/Group Title IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Placebo
Hide Arm/Group Description IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21. IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21. phosphate buffered saline, given IM at Day 0 and Day 21.
Period Title: Overall Study
Started 31 32 12
Completed 31 32 12
Not Completed 0 0 0
Arm/Group Title IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Placebo Total
Hide Arm/Group Description IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21. IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21. phosphate buffered saline, given IM at Day 0 and Day 21. Total of all reporting groups
Overall Number of Baseline Participants 31 32 12 75
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 12 participants 75 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
31
 100.0%
32
 100.0%
12
 100.0%
75
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Full Range)
Unit of measure:  Years
Number Analyzed 31 participants 32 participants 12 participants 75 participants
23.7
(19 to 30)
23.5
(19 to 30)
23.7
(18 to 28)
23.6
(18 to 30)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 12 participants 75 participants
Female
11
  35.5%
13
  40.6%
7
  58.3%
31
  41.3%
Male
20
  64.5%
19
  59.4%
5
  41.7%
44
  58.7%
Race/Ethnicity, Customized  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 12 participants 75 participants
Kinh 31 32 12 75
Khmer 0 0 0 0
Hoa 0 0 0 0
Other 0 0 0 0
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants 32 participants 12 participants 75 participants
Asian
31
 100.0%
32
 100.0%
12
 100.0%
75
 100.0%
Other
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Vietnam Number Analyzed 31 participants 32 participants 12 participants 75 participants
31 32 12 75
1.Primary Outcome
Title Immediate Reactions Occurring Within 60 Minutes of Administration of Any Dose
Hide Description Data presented are after 1st and 2nd vaccination combined. All participants were observed for immediate reactions for 60 minutes after administration of study product, with appropriate medical treatment readily available in case of an anaphylactic reaction following the administration of study product.
Time Frame 60 min post injection
Hide Outcome Measure Data
Hide Analysis Population Description
Intent to treat population.
Arm/Group Title IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Combined Vaccine Placebo
Hide Arm/Group Description:
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
Results of low and high doses combined
phosphate buffered saline, given IM at Day 0 and Day 21
Overall Number of Participants Analyzed 31 32 63 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
2.Primary Outcome
Title Number of Participants With at Least One Solicted Reactogenicity After Both Injections
Hide Description

Data presented are after 1st and 2nd vaccination combined. Solicted reactogenicity are local and systemic events that are expected after injection and specifically asked of the participant. Only reported reactogenicity is presented. If not shown, then no participant reported that reaction in any study group.

Local reactions are redness, swelling, pain, tenderness, and hardness. Systemic reactions are actual and subjective fever, chills, cough, difficulty breathing, runny nose, nasal congestion, sore throat, hoarseness of voice, headache, confusion. convulsions/seizures, fatigue/malaise, muscle aches (generalized), joint pain, pink or red eyes, sore eyes, itchy eyes, drainage from eyes. ear pain or discharge, rash, abdominal pain, diarrhea, vomiting, and jaundice.

Time Frame Within 7 days after injection
Hide Outcome Measure Data
Hide Analysis Population Description
Participants who were randomized and received study injections
Arm/Group Title IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Combined Vaccine Placebo
Hide Arm/Group Description:
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
The high- and low-dose vaccine participants combined
phosphate buffered saline, given IM at Day 0 and Day 21
Overall Number of Participants Analyzed 31 32 63 12
Measure Type: Count of Participants
Unit of Measure: Participants
Subjects with at least one solicted AE
26
  83.9%
26
  81.3%
52
  82.5%
4
  33.3%
Subjects with at least one local solicted AE
25
  80.6%
24
  75.0%
49
  77.8%
3
  25.0%
Subjects with at least one systemic solicited AE
13
  41.9%
14
  43.8%
27
  42.9%
4
  33.3%
Local reactions--Pain
18
  58.1%
16
  50.0%
34
  54.0%
1
   8.3%
Local reactions--Tenderness
21
  67.7%
23
  71.9%
44
  69.8%
3
  25.0%
Systemic reactogenicity--Abdominal pain
1
   3.2%
0
   0.0%
1
   1.6%
0
   0.0%
Systemic reactogenicity--Chills
1
   3.2%
3
   9.4%
4
   6.3%
0
   0.0%
Systemic reactogenicity--Cough
3
   9.7%
2
   6.3%
5
   7.9%
2
  16.7%
Systemic reactogenicity--Diarrhea
0
   0.0%
1
   3.1%
1
   1.6%
0
   0.0%
Systemic reactogenicity--Ear pain/discharge
0
   0.0%
1
   3.1%
1
   1.6%
0
   0.0%
Systemic reactogenicity--Fatigue/Malaise
3
   9.7%
5
  15.6%
8
  12.7%
2
  16.7%
Systemic reactogenicity--Fever
0
   0.0%
3
   9.4%
3
   4.8%
0
   0.0%
Systemic reactogenicity--Sore eyes
1
   3.2%
0
   0.0%
1
   1.6%
0
   0.0%
Systemic reactogenicity--Sore throat
2
   6.5%
2
   6.3%
4
   6.3%
2
  16.7%
3.Primary Outcome
Title Number of Participants With at Least One Unsolicited AE
Hide Description Summary of number of participants with at least one unsolicited AE after 1st and 2nd vaccination combined. Please see the adverse event section of this report for full details.
Time Frame Within 7 weeks of injection
Hide Outcome Measure Data
Hide Analysis Population Description

Intent to treat population. Please see more detail in the AE section of this posting.

Table 14.2.1.2.1 Summary of Unsolicited Adverse Events by System Organ Class and Preferred Term (After 1st and 2nd Vaccination Combined) Intention-to-Treat Population

Arm/Group Title IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Placebo
Hide Arm/Group Description:
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
phosphate buffered saline, given at Day 0 and Day 21
Overall Number of Participants Analyzed 31 32 12
Measure Type: Count of Participants
Unit of Measure: Participants
12
  38.7%
12
  37.5%
4
  33.3%
4.Primary Outcome
Title All Serious Adverse Events (SAEs) Occurring Within 3 Weeks of Receipt of Any Dose
Hide Description Summary data. Data presented are after 1st and 2nd injections combined. Please see AE reporting section of this report for full details.
Time Frame Within 3 weeks of any injection
Hide Outcome Measure Data
Hide Analysis Population Description
Table 14.2.2.3.1 Summary of Serious Unsolicited Adverse Events by System Organ Class and Preferred Term (After 1st and 2nd Vaccination Combined) Intention-to-Treat Population
Arm/Group Title IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Placebo
Hide Arm/Group Description:
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
phosphate buffered saline, given at Day 0 and Day 21
Overall Number of Participants Analyzed 31 32 12
Measure Type: Count of Participants
Unit of Measure: Participants
0
   0.0%
0
   0.0%
0
   0.0%
5.Secondary Outcome
Title The Proportion of Subjects Achieving a Hemagglutination Inhibition (HAI) Titer ≥ 1:40 Pre-vaccination (Day 0) to Post 2nd Vaccination (Day 49)
Hide Description [Not Specified]
Time Frame Day 0 to Day 49
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set--The Per-Protocol Analysis Set (PPAS) contained all study subjects who received 2 doses of vaccine or placebo and completed the Day 42 visit without major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
Arm/Group Title IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Combined Vaccine Placebo
Hide Arm/Group Description:
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
Low and high dose groups combined
phosphate buffered saline, given IM at Day 0 and Day 21
Overall Number of Participants Analyzed 31 32 63 12
Measure Type: Count of Participants
Unit of Measure: Participants
Post vaccination #1
7
  22.6%
9
  28.1%
16
  25.4%
0
   0.0%
Post vaccination #2
13
  41.9%
18
  56.3%
31
  49.2%
0
   0.0%
6.Secondary Outcome
Title The Proportion of Subjects Achieving a Four-fold Rise in HAI Between Doses or From Baseline to Post-Injection 2
Hide Description [Not Specified]
Time Frame Days 21 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set--The Per-Protocol Analysis Set (PPAS) contained all study subjects who received 2 doses of vaccine or placebo and completed the Day 42 visit without major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
Arm/Group Title IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Combined Vaccine Placebo
Hide Arm/Group Description:
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
Low and high dose groups combined
phosphate buffered saline, given IM at Day 0 and Day 21
Overall Number of Participants Analyzed 31 32 63 12
Measure Type: Count of Participants
Unit of Measure: Participants
Baseline to post 1st vaccination
11
  35.5%
12
  37.5%
23
  36.5%
0
   0.0%
From post 1st- to post 2nd vaccination
9
  29.0%
11
  34.4%
20
  31.7%
0
   0.0%
Baseline to 2nd vaccination
21
  67.7%
23
  71.9%
44
  69.8%
0
   0.0%
7.Secondary Outcome
Title Geometric Mean Titer (GMT) of Hemagglutination Inhibition After Each Dose
Hide Description [Not Specified]
Time Frame Days 0, 21 and 42
Hide Outcome Measure Data
Hide Analysis Population Description
Per-protocol analysis set--The Per-Protocol Analysis Set (PPAS) contained all study subjects who received 2 doses of vaccine or placebo and completed the Day 42 visit without major protocol violations that were determined to potentially interfere with immune response to the study vaccine.
Arm/Group Title IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Combined Vaccine Placebo
Hide Arm/Group Description:
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
Low and high dose groups combined
phosphate buffered saline, given IM at Day 0 and Day 21
Overall Number of Participants Analyzed 31 32 63 12
Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 0
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Post vaccination #1
12.8
(7.95 to 20.58)
11.9
(8.17 to 17.31)
12.3
(9.19 to 16.53)
5.00
(5.00 to 5.00)
Post vaccination #2
24.5
(15.51 to 38.58)
27.1
(19.98 to 36.71)
25.8
(19.77 to 33.57)
5.00
(5.00 to 5.00)
8.Secondary Outcome
Title Geometric Mean Titer (GMT) of Neutralizing Antibody After Each Dose
Hide Description [Not Specified]
Time Frame Days 0, 21, and 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Combined Vaccine Placebo
Hide Arm/Group Description:
IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21.
IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21.
Low and high dose groups combined
phosphate buffered saline, given IM at Day 0 and Day 21
Overall Number of Participants Analyzed 31 32 63 12
Mean (95% Confidence Interval)
Unit of Measure: Titers
Day 0
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
5.00
(5.00 to 5.00)
Post vaccination #1
9.4
(5.99 to 14.60)
9.4
(6.52 to 13.46)
9.4
(7.09 to 12.36)
5.00
(5.00 to 5.00)
Post vaccination #2
21.9
(13.91 to 34.38)
23.3
(16.54 to 32.76)
22.6
(17.16 to 29.70)
5.00
(5.00 to 5.00)
Time Frame 90 days
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Placebo
Hide Arm/Group Description IVACFLU-A/H5N1, 7.5 mcg HA per dose, given by intramuscular (IM) injection at Day 0 and Day 21. IVACFLU-A/H5N1, 15 mcg HA per dose, given IM at Day 0 and Day 21. phosphate buffered saline, given IM at Day 0 and Day 21.
All-Cause Mortality
IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Placebo
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/31 (0.00%)      0/32 (0.00%)      0/12 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/31 (0.00%)      0/32 (0.00%)      0/12 (0.00%)    
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 3%
IVACFLU-A/H5N1, 7.5 mcg IVACFLU-A/H5N1, 15 mcg Placebo
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/31 (38.71%)      12/32 (37.50%)      4/12 (33.33%)    
Ear and labyrinth disorders       
Otorrhea * 1  0/31 (0.00%)  0 1/32 (3.13%)  1 0/12 (0.00%)  0
Gastrointestinal disorders       
Apthous stomatitis * 1  0/31 (0.00%)  0 1/32 (3.13%)  1 0/12 (0.00%)  0
Nausea * 1  0/31 (0.00%)  0 1/32 (3.13%)  1 0/12 (0.00%)  0
General disorders       
Chills * 1  1/31 (3.23%)  1 0/32 (0.00%)  0 0/12 (0.00%)  0
Feeling hot * 1  0/31 (0.00%)  0 1/32 (3.13%)  1 0/12 (0.00%)  0
Malaise * 1  1/31 (3.23%)  1 0/32 (0.00%)  0 0/12 (0.00%)  0
Pyrexia * 1  1/31 (3.23%)  1 0/32 (0.00%)  0 1/12 (8.33%)  1
Immune system disorders       
Immune system disorders * 1 [1]  0/31 (0.00%)  0 0/32 (0.00%)  0 1/12 (8.33%)  1
Infections and infestations       
Infections * 1 [2]  0/31 (0.00%)  0 0/32 (0.00%)  0 1/12 (8.33%)  1
Injury, poisoning and procedural complications       
Clavicle fracture * 1  1/31 (3.23%)  1 0/32 (0.00%)  0 0/12 (0.00%)  0
Soft tissue injury * 1  0/31 (0.00%)  0 1/32 (3.13%)  1 0/12 (0.00%)  0
Investigations       
Blood bilirubin increased * 1  3/31 (9.68%)  3 0/32 (0.00%)  0 0/12 (0.00%)  0
Alanine aminotransferase increased * 1  0/31 (0.00%)  0 1/32 (3.13%)  1 0/12 (0.00%)  0
Heart rate increased * 1  1/31 (3.23%)  1 0/32 (0.00%)  0 0/12 (0.00%)  0
Nervous system disorders       
Headache * 1  3/31 (9.68%)  3 2/32 (6.25%)  2 2/12 (16.67%)  2
Dizziness * 1  0/31 (0.00%)  0 1/32 (3.13%)  1 0/12 (0.00%)  0
Dizziness postural * 1  1/31 (3.23%)  1 0/32 (0.00%)  0 0/12 (0.00%)  0
Psychiatric disorders       
Anxiety * 1  1/31 (3.23%)  1 0/32 (0.00%)  0 0/12 (0.00%)  0
Depressed mood * 1  1/31 (3.23%)  1 0/32 (0.00%)  0 0/12 (0.00%)  0
Reproductive system and breast disorders       
Dysmenorrhoea * 1  0/31 (0.00%)  0 1/32 (3.13%)  1 0/12 (0.00%)  0
Respiratory, thoracic and mediastinal disorders       
Cough * 1  5/31 (16.13%)  5 2/32 (6.25%)  2 2/12 (16.67%)  2
Dysphonia * 1  2/31 (6.45%)  2 1/32 (3.13%)  1 0/12 (0.00%)  0
Oropharanyngeal pain * 1  3/31 (9.68%)  3 2/32 (6.25%)  2 2/12 (16.67%)  2
Rhinorrhea * 1  5/31 (16.13%)  5 1/32 (3.13%)  1 1/12 (8.33%)  1
Skin and subcutaneous tissue disorders       
Pruritis * 1 [3]  0/31 (0.00%)  0 0/32 (0.00%)  0 1/12 (8.33%)  1
Pyrexia * 1  1/31 (3.23%)  1 0/32 (0.00%)  0 1/12 (8.33%)  1
Skin discolouration * 1  1/31 (3.23%)  1 0/32 (0.00%)  0 0/12 (0.00%)  0
1
Term from vocabulary, MedDRA (17.0)
*
Indicates events were collected by non-systematic assessment
[1]
Food allergy
[2]
Urinary tract infection
[3]
Pruritis (itchy skin)
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT 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
Name/Title: Dr. Le Van Be
Organization: IVAC
Responsible Party: Institute of Vaccines and Medical Biologicals, Vietnam
ClinicalTrials.gov Identifier: NCT02171819     History of Changes
Other Study ID Numbers: IVAC A/H5N1
VAC021 ( Other Identifier: PATH )
First Submitted: June 20, 2014
First Posted: June 24, 2014
Results First Submitted: November 11, 2018
Results First Posted: March 14, 2019
Last Update Posted: March 14, 2019