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Trial record 10 of 93849 for:    5

Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without Adjuvant System 03 (AS03)

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ClinicalTrials.gov Identifier: NCT01910519
Recruitment Status : Completed
First Posted : July 29, 2013
Results First Posted : February 12, 2019
Last Update Posted : February 12, 2019
Sponsor:
Collaborator:
Emory University
Information provided by (Responsible Party):
National Institute of Allergy and Infectious Diseases (NIAID)

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor);   Primary Purpose: Basic Science
Condition Influenza A Virus, H5N1 Subtype
Interventions Biological: H5N1 vaccine plus AS03 adjuvant
Biological: H5N1 vaccine without adjuvant
Enrollment 50
Recruitment Details Patients were randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with or without AS03 adjuvant undergoing scheduled anterior cruciate ligament (ACL) surgery at the Hope Clinic - Emory Vaccine Center in Decatur, Georgia. Participants were enrolled between July 2013 and January 2014.
Pre-assignment Details Of the 99 screened participants, 50 were enrolled and vaccinated. 2 participants withdrew from the study.
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Hide Arm/Group Description Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
Period Title: Overall Study
Started 35 15
Completed 31 15
Not Completed 4 0
Reason Not Completed
Withdrawal by Subject             2             0
Adverse Event             2             0
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv Total
Hide Arm/Group Description Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant Total of all reporting groups
Overall Number of Baseline Participants 35 15 50
Hide Baseline Analysis Population Description
[Not Specified]
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 15 participants 50 participants
<=18 years
0
   0.0%
0
   0.0%
0
   0.0%
Between 18 and 65 years
35
 100.0%
15
 100.0%
50
 100.0%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 35 participants 15 participants 50 participants
Female
22
  62.9%
8
  53.3%
30
  60.0%
Male
13
  37.1%
7
  46.7%
20
  40.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 35 participants 15 participants 50 participants
35 15 50
1.Primary Outcome
Title Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Hide Description To identify innate immune signatures; 1 day post first vaccination
Time Frame Day 1
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Hide Arm/Group Description:
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
Overall Number of Participants Analyzed 35 15
Measure Type: Number
Unit of Measure: differentially expressed genes (DEGs)
Upregulated 1434 128
Downregulated 1768 56
2.Primary Outcome
Title Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Hide Description To identify innate immune signatures; 3 days post first vaccination
Time Frame Day 3
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Hide Arm/Group Description:
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
Overall Number of Participants Analyzed 35 15
Measure Type: Number
Unit of Measure: differentially expressed genes (DEGs)
Upregulated 654 787
Downregulated 445 620
3.Primary Outcome
Title Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Hide Description To identify innate immune signatures; 7 days post first vaccination
Time Frame Day 7
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Hide Arm/Group Description:
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
Overall Number of Participants Analyzed 35 15
Measure Type: Number
Unit of Measure: differentially expressed genes (DEGs)
Upregulated 149 83
Downregulated 232 178
4.Primary Outcome
Title Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Hide Description To identify innate immune signatures; 1 day post second vaccination
Time Frame Day 22
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Hide Arm/Group Description:
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
Overall Number of Participants Analyzed 35 15
Measure Type: Number
Unit of Measure: differentially expressed genes (DEGs)
Upregulated 1953 81
Downregulated 2820 99
5.Primary Outcome
Title Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Hide Description To identify innate immune signatures; 3 days post second vaccination
Time Frame Day 24
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Hide Arm/Group Description:
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
Overall Number of Participants Analyzed 35 15
Measure Type: Number
Unit of Measure: differentially expressed genes (DEGs)
Upregulated 839 78
Downregulated 487 172
6.Primary Outcome
Title Change in Traditional Immune Parameters Measurements Using Luminex Assays and Gene Expression Measurement Using Microarray Experiments From Baseline With Influenza A Vaccine With and Without AS03 Adjuvant
Hide Description To identify innate immune signatures; 7 days post second vaccination
Time Frame Day 28
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Hide Arm/Group Description:
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
Overall Number of Participants Analyzed 35 15
Measure Type: Number
Unit of Measure: differentially expressed genes (DEGs)
Upregulated 63 34
Downregulated 28 52
7.Primary Outcome
Title Measurement of Hemagglutination Inhibition Assay (HAI) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
Hide Description To measure selective adaptive immune response; 21 days post first vaccination
Time Frame Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Hide Arm/Group Description:
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
Overall Number of Participants Analyzed 35 15
Mean (95% Confidence Interval)
Unit of Measure: IU/ml
5.561
(4.976 to 6.213)
5
(5 to 5)
8.Primary Outcome
Title Measurement of Microneutralization (MN) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
Hide Description To measure selective adaptive immune response; 21 days post first vaccination
Time Frame Day 21
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Hide Arm/Group Description:
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
Overall Number of Participants Analyzed 35 15
Mean (95% Confidence Interval)
Unit of Measure: IU/ml
30.18
(23.08 to 39.47)
10.44
(9.522 to 11.45)
9.Primary Outcome
Title Measurement of Hemagglutination Inhibition Assay (HAI) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
Hide Description To measure selective adaptive immune response; 21 days post second vaccination
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Hide Arm/Group Description:
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
Overall Number of Participants Analyzed 35 15
Mean (95% Confidence Interval)
Unit of Measure: IU/ml
41.3
(26.19 to 65.12)
5.183
(4.919 to 5.462)
10.Primary Outcome
Title Measurement of Microneutralization (MN) Titers With Influenza A Vaccine With and Without AS03 Adjuvant
Hide Description To measure selective adaptive immune response; 21 days post second vaccination
Time Frame Day 42
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Hide Arm/Group Description:
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant
Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
Overall Number of Participants Analyzed 35 15
Mean (95% Confidence Interval)
Unit of Measure: IU/ml
523.3
(354.5 to 772.5)
22.78
(13.46 to 38.55)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant, Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Comments Correlation of vaccine-induced blood transcription modules (BTMs) M183-TBA at day 1 with MN titers at day 42
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0039
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 2 Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant, Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Comments Correlation of vaccine-induced blood transcription modules (BTMs) M115-cytokines-receptors cluster at day 1 with MN titers at day 42
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0368
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 3 Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant, Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Comments Correlation of vaccine-induced blood transcription modules (BTMs) M74-transcriptional targets of glucocorticoid receptor at day 1 with MN titers at day 42
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0465
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 4 Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant, Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Comments Correlation of vaccine-induced blood transcription modules (BTMs) M58-B cell development/activation at day 1 with MN titers at day 42
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0411
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Show Statistical Analysis 5 Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant, Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Comments Correlation of vaccine-induced blood transcription modules (BTMs) M114.0-TBA at day 1 with MN titers at day 42
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0067
Comments [Not Specified]
Method ANOVA
Comments [Not Specified]
Time Frame Day 0 - Day 7 after 2 intramuscular doses of Influenza A (H5N1) Virus Monovalent Vaccine with or without AS03 adjuvant given 21 days apart.
Adverse Event Reporting Description Local and systemic reactogenicity after receipt of each vaccine
 
Arm/Group Title Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Hide Arm/Group Description Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine with AS03 adjuvant Participants randomized to receive Influenza A (H5N1) Virus Monovalent Vaccine without AS03 adjuvant
All-Cause Mortality
Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Affected / at Risk (%) Affected / at Risk (%)
Total   0/35 (0.00%)      0/15 (0.00%)    
Show Serious Adverse Events Hide Serious Adverse Events
Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/35 (2.86%)      0/15 (0.00%)    
Pregnancy, puerperium and perinatal conditions     
Missed abortion (unrelated to study vaccine) * [1]  1/35 (2.86%)  1 0/15 (0.00%)  0
*
Indicates events were collected by non-systematic assessment
[1]
Missed abortion
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Influenza A (H5N1) Virus Monovalent Vaccine With AS03 Adjuvant Influenza A (H5N1) Virus Monovalent Vaccine Without AS03 Adjuv
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   34/35 (97.14%)      12/15 (80.00%)    
Blood and lymphatic system disorders     
Anemia *  2/35 (5.71%)  2 2/15 (13.33%)  2
Gastrointestinal disorders     
Diarrhea *  3/35 (8.57%)  3 0/15 (0.00%)  0
General disorders     
Body ache *  13/35 (37.14%)  16 2/15 (13.33%)  2
Fever *  1/35 (2.86%)  1 1/15 (6.67%)  2
Nausea *  3/35 (8.57%)  4 3/15 (20.00%)  3
Malaise *  0/35 (0.00%)  0 1/15 (6.67%)  1
Vomiting *  1/35 (2.86%)  1 0/15 (0.00%)  0
Immune system disorders     
Allergic reaction *  2/35 (5.71%)  2 1/15 (6.67%)  1
Infections and infestations     
Upper Respiratory Infections *  2/35 (5.71%)  2 0/15 (0.00%)  0
Musculoskeletal and connective tissue disorders     
Joint pain *  5/35 (14.29%)  5 0/15 (0.00%)  0
Renal and urinary disorders     
Renal calculi *  0/35 (0.00%)  0 1/15 (6.67%)  1
Respiratory, thoracic and mediastinal disorders     
Nasal congestion *  2/35 (5.71%)  2 1/15 (6.67%)  1
*
Indicates events were collected by non-systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Nadine Rouphael MD
Organization: Emory University
Phone: 404-712-1435
EMail: nroupha@emory.edu
Layout table for additonal information
Responsible Party: National Institute of Allergy and Infectious Diseases (NIAID)
ClinicalTrials.gov Identifier: NCT01910519     History of Changes
Other Study ID Numbers: DAIT HIPC: VAX-010
1U19AI090023-01 ( U.S. NIH Grant/Contract )
First Submitted: July 23, 2013
First Posted: July 29, 2013
Results First Submitted: January 2, 2019
Results First Posted: February 12, 2019
Last Update Posted: February 12, 2019