Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults (QLAIV)
Primary Purpose
Human Immunodeficiency Virus (HIV)
Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Quadrivalent Live Attenuated Influenza Vaccine
Sponsored by
About this trial
This is an interventional health services research trial for Human Immunodeficiency Virus (HIV) focused on measuring Shedding, Immunogenicity, Safety, HIV infected, Children, Young adults
Eligibility Criteria
Inclusion Criteria:
- Age 2-25
- Only supposed to get one dose of vaccine for upcoming influenza season
- No viral respiratory symptoms at time of immunization
HIV-infected group: must have:
- HIV-infection documented by 2 tests such as positive serology, positive HIV DNA or positive HIV RNA;
- must thave a CD4>25% or 500, or
- must have CD4>15% or 200 and be on HAART
- Healthy controls: no major medical problems affecting the immune system
Recruited among:
- HIV-unifected clients of the Children's Immunodeficiency Program(CHIP),
- Children's Hospital Colorado Child Health Clinic and Adolescent Clinics.
Exclusion Criteria:
History of:
- reactive airway disease,
- recurrent wheezing, or
- asthma
- Active wheezing at time of immunization
- On any antiviral agents active against influenza (amantadien/rimantadine, zanamavir, oseltamivir) at time of immunization or planned over 21 days of shedding collection
- Receipt of IVIG within 3 months prior to enrollment
- Plan to receive IVIG during the 4 weeks after immunization
- Moderate to severely immunocompromised individual living in the home
- Pregnant
- Breastfeeding
- Plan to start immunosupressive medications or stop HAART over the 4 weeks following immmunization
- Temperature > 100F or 37.8C
- Rhinorrhea or cough not related to allergies at the time of immunization
- History of fungal sinusitis
- History of Guillain-Barre Syndrome
- Current on antibiotics
- Currently taking aspirin
- On an investigational drug at the time of immunization or planned over the 28 days of shedding collection
- On any experimental medication at time of immunization or planned over 21 days of shedding collection
Sites / Locations
- University of Colorado Denver
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
QLAIV, HIV-infected
QLAIV, HIV-uninfected
Arm Description
QLAIV administered to HIV-infected individuals 2 to 25 yoa
QLAIV administered to HIV-uninfected individuals 2 to 25 yoa
Outcomes
Primary Outcome Measures
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.
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.
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.
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.)
Secondary Outcome Measures
Number of Participants With Adverse Events Within 14 Days After Vaccination
The 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.
Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups.
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.
Full Information
NCT ID
NCT02474901
First Posted
June 15, 2015
Last Updated
October 17, 2017
Sponsor
University of Colorado, Denver
Collaborators
MedImmune LLC
1. Study Identification
Unique Protocol Identification Number
NCT02474901
Brief Title
Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults
Acronym
QLAIV
Official Title
Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults
Study Type
Interventional
2. Study Status
Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
July 2013 (Actual)
Primary Completion Date
March 2016 (Actual)
Study Completion Date
December 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Colorado, Denver
Collaborators
MedImmune LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The goal of this study is to determine if there is a difference in shedding (primary objective) and in immunogenicity and safety (secondary objectives) between HIV-positive and HIV-negative children and young adults who are receiving the quadrivalent live-attenuated influenza vaccine (QLAIV).
Detailed Description
QLAIV is an intranasal vaccine that works by using 4 different attenuated strains of influenza virus that will replicate in the nose and stimulate an immune response in recipients that should protect them if they are infected with one of those strains of influenza in the future. A couple of studies have shown an increase in duration that the viruses remain in the nose in immunocompromised people. Those studies were done using the trivalent vaccine, so the investigators would like to evaluate the quadrivalent vaccine, and there is still a need for additional data to help understand the duration of shedding. If shedding is prolonged in HIV-infected children and young adults, it would be important to know for contacts of those individuals who are very immunocompromised. Shedding will be measured by looking for influenza RNA in nasopharyngeal swabs taken at baseline, 2-5 days, 7-10 days and 14-21 days after the intranasal immunization.
The live-attenuated influenza vaccines have been shown to have increased effectiveness in children and they stimulate the immune system in a different way than the inactivated influenza vaccines (TIV or QIV). In this study, the investigators will have the opportunity to compare the immunogenicity of QLAIV, measured at baseline and 14-21 days post-vaccination, in HIV-infected and uninfected children, adolescents and young adults. Although prior studies of LAIV in HIV-infected and other immunocompromised children and adults have not shown any increase in serious adverse events, safety will be actively monitored for the first 30-45 days through a study-specific questionnaire administered at each clinic or phone visit and by asking the subjects to keep a diary of side effects. Safety will be monitored passively throughout the course of the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Human Immunodeficiency Virus (HIV)
Keywords
Shedding, Immunogenicity, Safety, HIV infected, Children, Young adults
7. Study Design
Primary Purpose
Health Services Research
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Open label
Allocation
Non-Randomized
Enrollment
101 (Actual)
8. Arms, Groups, and Interventions
Arm Title
QLAIV, HIV-infected
Arm Type
Active Comparator
Arm Description
QLAIV administered to HIV-infected individuals 2 to 25 yoa
Arm Title
QLAIV, HIV-uninfected
Arm Type
Active Comparator
Arm Description
QLAIV administered to HIV-uninfected individuals 2 to 25 yoa
Intervention Type
Biological
Intervention Name(s)
Quadrivalent Live Attenuated Influenza Vaccine
Other Intervention Name(s)
FluMist Quadrivalent, QLAIV
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
21 days
Title
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.
Description
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.)
Time Frame
day 0-21 post-vaccine
Secondary Outcome Measure Information:
Title
Number of Participants With Adverse Events Within 14 Days After Vaccination
Description
The 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.
Time Frame
14 days after vaccination for AEs; up to 30 days for unscheduled visits
Title
Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups.
Description
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.
Time Frame
14-21 days
Other Pre-specified Outcome Measures:
Title
Number of Participants With PCR-diagnosed Influenza and Clinically-diagnosed Influenza Like Illness.
Description
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).
Time Frame
up to 11 months post-vaccination
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
25 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 2-25
Only supposed to get one dose of vaccine for upcoming influenza season
No viral respiratory symptoms at time of immunization
HIV-infected group: must have:
HIV-infection documented by 2 tests such as positive serology, positive HIV DNA or positive HIV RNA;
must thave a CD4>25% or 500, or
must have CD4>15% or 200 and be on HAART
Healthy controls: no major medical problems affecting the immune system
Recruited among:
HIV-unifected clients of the Children's Immunodeficiency Program(CHIP),
Children's Hospital Colorado Child Health Clinic and Adolescent Clinics.
Exclusion Criteria:
History of:
reactive airway disease,
recurrent wheezing, or
asthma
Active wheezing at time of immunization
On any antiviral agents active against influenza (amantadien/rimantadine, zanamavir, oseltamivir) at time of immunization or planned over 21 days of shedding collection
Receipt of IVIG within 3 months prior to enrollment
Plan to receive IVIG during the 4 weeks after immunization
Moderate to severely immunocompromised individual living in the home
Pregnant
Breastfeeding
Plan to start immunosupressive medications or stop HAART over the 4 weeks following immmunization
Temperature > 100F or 37.8C
Rhinorrhea or cough not related to allergies at the time of immunization
History of fungal sinusitis
History of Guillain-Barre Syndrome
Current on antibiotics
Currently taking aspirin
On an investigational drug at the time of immunization or planned over the 28 days of shedding collection
On any experimental medication at time of immunization or planned over 21 days of shedding collection
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adriana Weinberg, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Myron Levin, MD
Organizational Affiliation
University of Colorado, Denver
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Donna Curtis, MD,MPH
Organizational Affiliation
University of Colorado, Denver
Official's Role
Study Director
Facility Information:
Facility Name
University of Colorado Denver
City
Denver
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults
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