Trial Outcomes & Findings for Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults (NCT NCT02474901)
NCT ID: NCT02474901
Last Updated: 2017-11-20
Results Overview
Measure PCR positivity for any of the influenza subtypes included in QLAIV between baseline (day 0) and the last study visit at 14-21 days after vaccine. Compare number of participants with PCR positivity for any of the vaccine-strain influenza virus strains in each patient group.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
21 days
Results posted on
2017-11-20
Participant Flow
Participant milestones
| Measure |
QLAIV, HIV-uninfected
QLAIV administered to HIV-uninfected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
QLAIV, HIV-infected
QLAIV administered to HIV-infected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
56
|
|
Overall Study
COMPLETED
|
44
|
56
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults
Baseline characteristics by cohort
| Measure |
QLAIV, HIV-infected
n=45 Participants
QLAIV administered to HIV-infected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
QLAIV, HIV-uninfected
n=56 Participants
QLAIV administered to HIV-uninfected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
Total
n=101 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
10 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
32 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
35 Participants
n=5 Participants
|
34 Participants
n=7 Participants
|
69 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
18 years
n=5 Participants
|
10 years
n=7 Participants
|
12 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
43 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
28 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
20 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
38 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
45 Participants
n=7 Participants
|
64 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
45 participants
n=5 Participants
|
56 participants
n=7 Participants
|
101 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 21 daysPopulation: HIV-infected and uninfected recipients of QLAIV; one HIV-uninfected subject was lost-to-follow-up after the first follow-up visit following vaccination.
Measure PCR positivity for any of the influenza subtypes included in QLAIV between baseline (day 0) and the last study visit at 14-21 days after vaccine. Compare number of participants with PCR positivity for any of the vaccine-strain influenza virus strains in each patient group.
Outcome measures
| Measure |
QLAIV, HIV-infected
n=45 Participants
QLAIV administered to HIV-infected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
QLAIV, HIV-uninfected
n=56 Participants
QLAIV administered to HIV-uninfected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
|---|---|---|
|
Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV in the First 21 Days After Vaccine Administration Days in HIV-positive and Control Groups.
Baseline analysis for virus (before vaccine)
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV in the First 21 Days After Vaccine Administration Days in HIV-positive and Control Groups.
Shed any virus anytime up to 21 days post-vaccine
|
30 Participants
|
28 Participants
|
PRIMARY outcome
Timeframe: day 0-21 post-vaccinePopulation: Subjects with data for any of the visits
Measure PCR positivity for any of the influenza subtypes included in QLAIV at visit 1 (day 0), visit 2 (days 2-5), visit 3 (days 7-10) and visit 4 (days 14-21). Compare number of participants with shedding for any subtype in each patient group. (The study was powered based on the 7-10 day data.)
Outcome measures
| Measure |
QLAIV, HIV-infected
n=45 Participants
QLAIV administered to HIV-infected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
QLAIV, HIV-uninfected
n=55 Participants
QLAIV administered to HIV-uninfected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
|---|---|---|
|
Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV Vaccine at Each of the 4 Study Visits, Days 0 (Baseline), 2-5, 7-10, and 14-21 in HIV-positive and Control Groups.
Visit 1, day 0
|
0 Participants
|
0 Participants
|
|
Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV Vaccine at Each of the 4 Study Visits, Days 0 (Baseline), 2-5, 7-10, and 14-21 in HIV-positive and Control Groups.
Visit 2, days 2-5
|
30 Participants
|
27 Participants
|
|
Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV Vaccine at Each of the 4 Study Visits, Days 0 (Baseline), 2-5, 7-10, and 14-21 in HIV-positive and Control Groups.
Visit 3, days 7-10
|
13 Participants
|
11 Participants
|
|
Number of Participants With Shedding for at Least One of the Influenza Strains Included in the QLAIV Vaccine at Each of the 4 Study Visits, Days 0 (Baseline), 2-5, 7-10, and 14-21 in HIV-positive and Control Groups.
Visit 4, days 14-21
|
1 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: 14 days after vaccination for AEs; up to 30 days for unscheduled visitsThe investigators will compare the number of adverse events (AE) reported by AE category within 14 days after vaccination as reported by each participant. Data will reflect whether a participant ever reported the AE, and not the number of times the AE was reported.
Outcome measures
| Measure |
QLAIV, HIV-infected
n=45 Participants
QLAIV administered to HIV-infected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
QLAIV, HIV-uninfected
n=55 Participants
QLAIV administered to HIV-uninfected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
|---|---|---|
|
Number of Participants With Adverse Events Within 14 Days After Vaccination
Temperature >100F
|
0 Participants
|
1 Participants
|
|
Number of Participants With Adverse Events Within 14 Days After Vaccination
Runny nose
|
17 Participants
|
16 Participants
|
|
Number of Participants With Adverse Events Within 14 Days After Vaccination
Nasal congestion
|
17 Participants
|
16 Participants
|
|
Number of Participants With Adverse Events Within 14 Days After Vaccination
Sore throat
|
6 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events Within 14 Days After Vaccination
Headache
|
8 Participants
|
8 Participants
|
|
Number of Participants With Adverse Events Within 14 Days After Vaccination
Muscle aches
|
8 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events Within 14 Days After Vaccination
Decrease in energy
|
11 Participants
|
3 Participants
|
|
Number of Participants With Adverse Events Within 14 Days After Vaccination
Decreased appetite
|
6 Participants
|
2 Participants
|
|
Number of Participants With Adverse Events Within 14 Days After Vaccination
Any other symptom
|
9 Participants
|
5 Participants
|
|
Number of Participants With Adverse Events Within 14 Days After Vaccination
Unscheduled medical visits in 30 days post vaccine
|
2 Participants
|
10 Participants
|
SECONDARY outcome
Timeframe: 14-21 daysPopulation: The total number of participants analyzed reflect the number of subjects for whom there was a blood sample from the 4th visit at day 14-21.
The investigators will measure hemagglutinin inhibition (HAI) on blood samples #2 (14-21 days after vaccination) for all participants. The investigators will also compare the number of participants reaching HAI ≥ 40 for each virus sub-type contained in the vaccine.
Outcome measures
| Measure |
QLAIV, HIV-infected
n=44 Participants
QLAIV administered to HIV-infected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
QLAIV, HIV-uninfected
n=51 Participants
QLAIV administered to HIV-uninfected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
|---|---|---|
|
Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups.
H1N1
|
35 Participants
|
35 Participants
|
|
Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups.
H3N2
|
27 Participants
|
35 Participants
|
|
Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups.
B-Victoria
|
7 Participants
|
4 Participants
|
|
Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups.
B-Yamagata
|
7 Participants
|
7 Participants
|
OTHER_PRE_SPECIFIED outcome
Timeframe: up to 11 months post-vaccinationPopulation: Number of participants analyzed reflects the number of subjects who participated in the end-of-season interview.
Compare numbers of participants with influenza diagnosed by PCR and with clinically-diagnosed influenza between the two groups. Data was taken from Influenza Infection Questionnaires #1 and #2. The last questionnaire (#2) was administered between May 15 and June 10, 2014 (after the vaccine). Data is reported as PCR-confirmed influenza and clinically-diagnosed influenza (subject told had influenza without confirmatory testing).
Outcome measures
| Measure |
QLAIV, HIV-infected
n=17 Participants
QLAIV administered to HIV-infected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
QLAIV, HIV-uninfected
n=53 Participants
QLAIV administered to HIV-uninfected individuals 2 to 25 yoa
Quadrivalent Live Attenuated Influenza Vaccine
|
|---|---|---|
|
Number of Participants With PCR-diagnosed Influenza and Clinically-diagnosed Influenza Like Illness.
PCR-confirmed influenza
|
0 Participants
|
1 Participants
|
|
Number of Participants With PCR-diagnosed Influenza and Clinically-diagnosed Influenza Like Illness.
clinically-diagnosed influenza
|
2 Participants
|
2 Participants
|
Adverse Events
QLAIV, HIV-infected
Serious events: 1 serious events
Other events: 17 other events
Deaths: 0 deaths
QLAIV, HIV-uninfected
Serious events: 0 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
QLAIV, HIV-infected
n=45 participants at risk
Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) administered to HIV-infected individuals 2 to 25 yoa
|
QLAIV, HIV-uninfected
n=55 participants at risk
Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) administered to HIV-uninfected individuals 2 to 25 yoa
|
|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
bleeding
|
2.2%
1/45 • Number of events 1 • 1 year
HIV-infected and HIV-uninfected individuals
|
0.00%
0/55 • 1 year
HIV-infected and HIV-uninfected individuals
|
Other adverse events
| Measure |
QLAIV, HIV-infected
n=45 participants at risk
Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) administered to HIV-infected individuals 2 to 25 yoa
|
QLAIV, HIV-uninfected
n=55 participants at risk
Quadrivalent Live Attenuated Influenza Vaccine (QLAIV) administered to HIV-uninfected individuals 2 to 25 yoa
|
|---|---|---|
|
General disorders
Temperature >100F
|
0.00%
0/45 • 1 year
HIV-infected and HIV-uninfected individuals
|
1.8%
1/55 • Number of events 1 • 1 year
HIV-infected and HIV-uninfected individuals
|
|
Respiratory, thoracic and mediastinal disorders
Runny nose
|
37.8%
17/45 • Number of events 21 • 1 year
HIV-infected and HIV-uninfected individuals
|
29.1%
16/55 • Number of events 28 • 1 year
HIV-infected and HIV-uninfected individuals
|
|
Respiratory, thoracic and mediastinal disorders
Nasal congestion
|
37.8%
17/45 • Number of events 21 • 1 year
HIV-infected and HIV-uninfected individuals
|
29.1%
16/55 • Number of events 24 • 1 year
HIV-infected and HIV-uninfected individuals
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
13.3%
6/45 • Number of events 7 • 1 year
HIV-infected and HIV-uninfected individuals
|
9.1%
5/55 • Number of events 6 • 1 year
HIV-infected and HIV-uninfected individuals
|
|
Nervous system disorders
Headache
|
17.8%
8/45 • Number of events 14 • 1 year
HIV-infected and HIV-uninfected individuals
|
14.5%
8/55 • Number of events 9 • 1 year
HIV-infected and HIV-uninfected individuals
|
|
General disorders
Muscle aches
|
17.8%
8/45 • Number of events 11 • 1 year
HIV-infected and HIV-uninfected individuals
|
3.6%
2/55 • Number of events 2 • 1 year
HIV-infected and HIV-uninfected individuals
|
|
General disorders
Decrease in energy
|
24.4%
11/45 • Number of events 16 • 1 year
HIV-infected and HIV-uninfected individuals
|
5.5%
3/55 • Number of events 3 • 1 year
HIV-infected and HIV-uninfected individuals
|
|
Gastrointestinal disorders
Decreased appetite
|
13.3%
6/45 • Number of events 10 • 1 year
HIV-infected and HIV-uninfected individuals
|
3.6%
2/55 • Number of events 2 • 1 year
HIV-infected and HIV-uninfected individuals
|
|
General disorders
Any other symptoms
|
20.0%
9/45 • Number of events 9 • 1 year
HIV-infected and HIV-uninfected individuals
|
9.1%
5/55 • Number of events 6 • 1 year
HIV-infected and HIV-uninfected individuals
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place