Trial Outcomes & Findings for Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals (NCT NCT01262846)
NCT ID: NCT01262846
Last Updated: 2017-04-13
Results Overview
To compare the immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals.
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
195 participants
Primary outcome timeframe
Baseline to 21 days
Results posted on
2017-04-13
Participant Flow
Participant milestones
| Measure |
Fluzone SD
Fluzone® Standard dose
Fluzone®: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.
|
Fluzone® High Dose
Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.
Fluzone®: Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.
|
|---|---|---|
|
Overall Study
STARTED
|
95
|
100
|
|
Overall Study
COMPLETED
|
93
|
97
|
|
Overall Study
NOT COMPLETED
|
2
|
3
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Improving Immunogenicity of Influenza Vaccine in HIV Infected Individuals
Baseline characteristics by cohort
| Measure |
Fluzone SD
n=95 Participants
Fluzone® Standard dose
Fluzone®: Fluzone® Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.
|
Fluzone® High Dose
n=100 Participants
Fluzone® High dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.
Fluzone®: Fluzone® High dose or Standard dose in a blinded manner as single-0.5mL injection intramuscularly into one of the subject's deltoid muscles.
|
Total
n=195 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46 years
n=93 Participants
|
44 years
n=4 Participants
|
45 years
n=27 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
36 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
73 Participants
n=93 Participants
|
64 Participants
n=4 Participants
|
137 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
3 Participants
n=4 Participants
|
10 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
88 Participants
n=93 Participants
|
97 Participants
n=4 Participants
|
185 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Black or African American
|
58 Participants
n=93 Participants
|
78 Participants
n=4 Participants
|
136 Participants
n=27 Participants
|
|
Race (NIH/OMB)
White
|
36 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
58 Participants
n=27 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
00 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline to 21 daysPopulation: All participants except 5 participants with missing data at day 21
To compare the immunogenicity of trivalent Fluzone® High-Dose vaccine vs the regular standard-dose (SD) in HIV infected individuals.
Outcome measures
| Measure |
SD Recipients
n=93 Participants
Fluzone Regular Dose
|
HD Recipients
n=97 Participants
Fluzone High Dose
|
|---|---|---|
|
Immunogenicity
Week 3 H3N2 A/Victoria/210/2009 X-187
|
324 Geometric Mean antibody titer
Interval 227.0 to 464.0
|
739 Geometric Mean antibody titer
Interval 529.0 to 1032.0
|
|
Immunogenicity
Baseline B/Brisbane/60/2008 (influenza B)
|
17 Geometric Mean antibody titer
Interval 11.0 to 25.0
|
20 Geometric Mean antibody titer
Interval 14.0 to 28.0
|
|
Immunogenicity
Baseline H1N1 (A/California/07/2009 X-179 A)
|
22 Geometric Mean antibody titer
Interval 14.0 to 37.0
|
25 Geometric Mean antibody titer
Interval 15.0 to 40.0
|
|
Immunogenicity
Week 3 H1N1 (A/California/07/2009 X-179 A)
|
344 Geometric Mean antibody titer
Interval 229.0 to 518.0
|
686 Geometric Mean antibody titer
Interval 509.0 to 926.0
|
|
Immunogenicity
Baseline H3N2 A/Victoria/210/2009 X-187
|
25 Geometric Mean antibody titer
Interval 16.0 to 42.0
|
26 Geometric Mean antibody titer
Interval 16.0 to 42.0
|
|
Immunogenicity
Week 3 B/Brisbane/60/2008 (influenza B)
|
64 Geometric Mean antibody titer
Interval 46.0 to 91.0
|
140 Geometric Mean antibody titer
Interval 110.0 to 178.0
|
Adverse Events
SD Recipients
Serious events: 3 serious events
Other events: 73 other events
Deaths: 0 deaths
HD Recipients
Serious events: 0 serious events
Other events: 90 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
SD Recipients
n=95 participants at risk
|
HD Recipients
n=100 participants at risk
|
|---|---|---|
|
General disorders
Hospitalization
|
3.2%
3/95
|
0.00%
0/100
|
|
General disorders
Death
|
0.00%
0/95
|
0.00%
0/100
|
Other adverse events
| Measure |
SD Recipients
n=95 participants at risk
|
HD Recipients
n=100 participants at risk
|
|---|---|---|
|
Skin and subcutaneous tissue disorders
Pain
|
4.2%
4/95 • Number of events 4
|
15.0%
15/100 • Number of events 15
|
|
Skin and subcutaneous tissue disorders
Redness
|
1.1%
1/95 • Number of events 1
|
3.0%
3/100 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Induration
|
1.1%
1/95 • Number of events 1
|
2.0%
2/100 • Number of events 2
|
|
Skin and subcutaneous tissue disorders
Tenderness
|
10.5%
10/95 • Number of events 10
|
10.0%
10/100 • Number of events 10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
3.2%
3/95 • Number of events 3
|
5.0%
5/100 • Number of events 5
|
|
General disorders
Chills
|
3.2%
3/95 • Number of events 3
|
5.0%
5/100 • Number of events 5
|
|
Gastrointestinal disorders
Diarrhea
|
1.1%
1/95 • Number of events 1
|
0.00%
0/100
|
|
Gastrointestinal disorders
Nausea
|
8.4%
8/95 • Number of events 8
|
7.0%
7/100 • Number of events 7
|
|
General disorders
Headache
|
9.5%
9/95 • Number of events 9
|
8.0%
8/100 • Number of events 8
|
|
Infections and infestations
Lymphadenopathy
|
1.1%
1/95 • Number of events 1
|
0.00%
0/100
|
|
General disorders
Malaise
|
14.7%
14/95 • Number of events 14
|
13.0%
13/100 • Number of events 13
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
17.9%
17/95 • Number of events 17
|
19.0%
19/100 • Number of events 19
|
|
Gastrointestinal disorders
vomiting
|
1.1%
1/95 • Number of events 1
|
3.0%
3/100 • Number of events 3
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place