Trial Outcomes & Findings for Immune Responses to H5N1 Vaccine With and Without AS03 Adjuvant (NCT NCT01578317)
NCT ID: NCT01578317
Last Updated: 2019-02-26
Results Overview
Flu Antibody titers at days 0, 21, 42, 100. Antibody-neutralization titers by microneutralization were measured against five different H5N1 virus strains (i.e., A/Vietnam/1194/2004 (clade 1), A/Indonesia/5/2005 (clade 2.1), A/Turkey/15/2006 (clade 2.2), A/Egypt/3072/2010 (clade 2.2), and A/Anhui/1/2005 (clade 2.3.4)) at day 0 (prevaccination), day 21 (post first vaccination), day 42 (post second vaccination) and day 100 postvaccination for AS03-adjuvanted group and unadjuvanted group. Sera were tested at an initial dilution of 1:20, and those that were negative (\<1:20) were assigned a titer of 10.
Recruitment status
COMPLETED
Study phase
PHASE1/PHASE2
Target enrollment
43 participants
Primary outcome timeframe
Days 0, 21, 42, and 100
Results posted on
2019-02-26
Participant Flow
Participant milestones
| Measure |
AS03 Adjuvanted
Adminsitered day 1, booster at Day 21
H5N1 vaccine plus AS03 adjuvant: H5N1 influenza vaccine with AS03 at the 3.75 mcg dose level given 21 days apart.
|
Unadjuvanted
Administer day 1 and booster at Day 21
H5N1 vaccine without adjuvant: H5N1 influenza vaccine non- adjuvanted form at the 3.75 mcg dose level given 21 days apart.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
21
|
|
Overall Study
Analysis Population
|
22
|
20
|
|
Overall Study
COMPLETED
|
22
|
20
|
|
Overall Study
NOT COMPLETED
|
0
|
1
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Immune Responses to H5N1 Vaccine With and Without AS03 Adjuvant
Baseline characteristics by cohort
| Measure |
AS03 Adjuvanted
n=22 Participants
Adminsitered day 1, booster at Day 21
H5N1 vaccine plus AS03 adjuvant: H5N1 influenza vaccine with AS03 at the 3.75 mcg dose level given 21 days apart.
|
Unadjuvanted
n=20 Participants
Administer day 1 and booster at Day 21
H5N1 vaccine without adjuvant: H5N1 influenza vaccine non- adjuvanted form at the 3.75 mcg dose level given 21 days apart.
|
Total
n=42 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
33.59 years
STANDARD_DEVIATION 6.64 • n=99 Participants
|
30.85 years
STANDARD_DEVIATION 5.62 • n=107 Participants
|
32.28 years
STANDARD_DEVIATION 6.25 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
9 Participants
n=99 Participants
|
8 Participants
n=107 Participants
|
17 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=99 Participants
|
2 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
21 Participants
n=99 Participants
|
18 Participants
n=107 Participants
|
39 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=99 Participants
|
4 Participants
n=107 Participants
|
10 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
12 Participants
n=107 Participants
|
25 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 Participants
n=99 Participants
|
20 Participants
n=107 Participants
|
42 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Days 0, 21, 42, and 100Flu Antibody titers at days 0, 21, 42, 100. Antibody-neutralization titers by microneutralization were measured against five different H5N1 virus strains (i.e., A/Vietnam/1194/2004 (clade 1), A/Indonesia/5/2005 (clade 2.1), A/Turkey/15/2006 (clade 2.2), A/Egypt/3072/2010 (clade 2.2), and A/Anhui/1/2005 (clade 2.3.4)) at day 0 (prevaccination), day 21 (post first vaccination), day 42 (post second vaccination) and day 100 postvaccination for AS03-adjuvanted group and unadjuvanted group. Sera were tested at an initial dilution of 1:20, and those that were negative (\<1:20) were assigned a titer of 10.
Outcome measures
| Measure |
AS03 Adjuvanted
n=22 Participants
Adminsitered day 1, booster at Day 21
H5N1 vaccine plus AS03 adjuvant: H5N1 influenza vaccine with AS03 at the 3.75 mcg dose level given 21 days apart.
|
Unadjuvanted
n=20 Participants
Administer day 1 and booster at Day 21
H5N1 vaccine without adjuvant: H5N1 influenza vaccine non- adjuvanted form at the 3.75 mcg dose level given 21 days apart.
|
|---|---|---|
|
Flu Antibody Titers
A/Indonesia/5/05 Day 0
|
10.65 Titers
Standard Deviation 6.4
|
10.35 Titers
Standard Deviation 2.24
|
|
Flu Antibody Titers
A/Indonesia/5/05 Day 21
|
31.09 Titers
Standard Deviation 60.53
|
10.35 Titers
Standard Deviation 2.24
|
|
Flu Antibody Titers
A/Indonesia/5/05 Day 42
|
600.92 Titers
Standard Deviation 487.05
|
20 Titers
Standard Deviation 74.64
|
|
Flu Antibody Titers
A/Indonesia/5/05 Day 100
|
218.57 Titers
Standard Deviation 133.05
|
18.59 Titers
Standard Deviation 49.14
|
|
Flu Antibody Titers
A/Turkey/15/2006 Day 0
|
10.32 Titers
Standard Deviation 2.13
|
10 Titers
Standard Deviation 0
|
|
Flu Antibody Titers
A/Turkey/15/2006 Day 21
|
10.99 Titers
Standard Deviation 15.95
|
10 Titers
Standard Deviation 0
|
|
Flu Antibody Titers
A/Turkey/15/2006 Day 42
|
93.65 Titers
Standard Deviation 313.55
|
10.72 Titers
Standard Deviation 6.71
|
|
Flu Antibody Titers
A/Turkey/15/2006 Day 100
|
34.82 Titers
Standard Deviation 20.12
|
11.16 Titers
Standard Deviation 3.75
|
|
Flu Antibody Titers
A/Egypt/3072/2010 Day 0
|
10.65 Titers
Standard Deviation 6.4
|
10 Titers
Standard Deviation 0
|
|
Flu Antibody Titers
A/Egypt/3072/2010 Day 21
|
14.59 Titers
Standard Deviation 34.83
|
10 Titers
Standard Deviation 0
|
|
Flu Antibody Titers
A/Egypt/3072/2010 Day 42
|
136.68 Titers
Standard Deviation 291.7
|
11.89 Titers
Standard Deviation 16.7
|
|
Flu Antibody Titers
A/Egypt/3072/2010 Day 100
|
40 Titers
Standard Deviation 35.02
|
11.57 Titers
Standard Deviation 9.46
|
|
Flu Antibody Titers
A/Anhui/1/2005 Day 0
|
10.65 Titers
Standard Deviation 6.4
|
10 Titers
Standard Deviation 0
|
|
Flu Antibody Titers
A/Anhui/1/2005 Day 21
|
12.87 Titers
Standard Deviation 16.77
|
10 Titers
Standard Deviation 0
|
|
Flu Antibody Titers
A/Anhui/1/2005 Day 42
|
106.23 Titers
Standard Deviation 173.42
|
10.72 Titers
Standard Deviation 6.71
|
|
Flu Antibody Titers
A/Anhui/1/2005 Day 100
|
45.95 Titers
Standard Deviation 33.78
|
12 Titers
Standard Deviation 9.55
|
|
Flu Antibody Titers
A/Vietnam/1203/2004 Day 0
|
10.65 Titers
Standard Deviation 6.4
|
10 Titers
Standard Deviation 0
|
|
Flu Antibody Titers
A/Vietnam/1203/2004 Day 21
|
10.99 Titers
Standard Deviation 14.92
|
10 Titers
Standard Deviation 0
|
|
Flu Antibody Titers
A/Vietnam/1203/2004 Day 42
|
20 Titers
Standard Deviation 66.76
|
10 Titers
Standard Deviation 0
|
|
Flu Antibody Titers
A/Vietnam/1203/2004 Day 100
|
11.49 Titers
Standard Deviation 15.69
|
10 Titers
Standard Deviation 0
|
Adverse Events
AS03 Adjuvanted
Serious events: 0 serious events
Other events: 17 other events
Deaths: 0 deaths
Unadjuvanted
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
AS03 Adjuvanted
n=22 participants at risk
Adminsitered day 1, booster at Day 21
H5N1 vaccine plus AS03 adjuvant: H5N1 influenza vaccine with AS03 at the 3.75 mcg dose level given 21 days apart.
|
Unadjuvanted
n=20 participants at risk
Administer day 1 and booster at Day 21
H5N1 vaccine without adjuvant: H5N1 influenza vaccine non- adjuvanted form at the 3.75 mcg dose level given 21 days apart.
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
13.6%
3/22 • Number of events 3
|
0.00%
0/20
|
|
Blood and lymphatic system disorders
Decreased Hemoglobin
|
9.1%
2/22 • Number of events 5
|
25.0%
5/20 • Number of events 5
|
|
Blood and lymphatic system disorders
Decreased Neutrophils
|
13.6%
3/22 • Number of events 3
|
15.0%
3/20 • Number of events 4
|
|
Blood and lymphatic system disorders
Decreased White Blood Cells
|
4.5%
1/22 • Number of events 1
|
15.0%
3/20 • Number of events 4
|
|
Blood and lymphatic system disorders
Increased White Blood Cells
|
13.6%
3/22 • Number of events 5
|
5.0%
1/20 • Number of events 1
|
|
General disorders
Fatigue
|
13.6%
3/22 • Number of events 4
|
5.0%
1/20 • Number of events 2
|
|
General disorders
Fever
|
31.8%
7/22 • Number of events 7
|
0.00%
0/20
|
|
Nervous system disorders
Headache
|
13.6%
3/22 • Number of events 4
|
15.0%
3/20 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Increased Respiratory Rate
|
13.6%
3/22 • Number of events 6
|
20.0%
4/20 • Number of events 8
|
|
Skin and subcutaneous tissue disorders
Injection Site Redness
|
4.5%
1/22 • Number of events 1
|
10.0%
2/20 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
27.3%
6/22 • Number of events 10
|
5.0%
1/20 • Number of events 2
|
|
Gastrointestinal disorders
Nausea
|
9.1%
2/22 • Number of events 2
|
10.0%
2/20 • Number of events 6
|
|
Skin and subcutaneous tissue disorders
Pain at Injection Site
|
27.3%
6/22 • Number of events 7
|
5.0%
1/20 • Number of events 1
|
|
Gastrointestinal disorders
Sore Throat
|
13.6%
3/22 • Number of events 3
|
0.00%
0/20
|
|
Cardiac disorders
Tachycardia
|
9.1%
2/22 • Number of events 2
|
5.0%
1/20 • Number of events 1
|
|
Cardiac disorders
Bradycardia
|
4.5%
1/22 • Number of events 1
|
10.0%
2/20 • Number of events 4
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place