Human Immunodeficiency Virus (HIV) Clinical Trial
— QLAIVOfficial title:
Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults
Verified date | October 2017 |
Source | University of Colorado, Denver |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 101 |
Est. completion date | December 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 2 Years to 25 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United States | University of Colorado Denver | Denver | Colorado |
Lead Sponsor | Collaborator |
---|---|
University of Colorado, Denver | MedImmune LLC |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Number of Participants With PCR-diagnosed Influenza and Clinically-diagnosed Influenza Like Illness. | 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). | up to 11 months post-vaccination | |
Primary | 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. | 21 days | |
Primary | 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.) | day 0-21 post-vaccine | |
Secondary | 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. | 14 days after vaccination for AEs; up to 30 days for unscheduled visits | |
Secondary | 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. | 14-21 days |
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