Overview

This trial is active, not recruiting.

Condition human immunodeficiency virus (hiv).
Treatment quadrivalent live attenuated influenza vaccine
Phase phase 2
Sponsor University of Colorado, Denver
Collaborator MedImmune LLC
Start date July 2013
End date March 2016
Trial size 110 participants
Trial identifier NCT02474901, 13-1752

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation non-randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose health services research
Arm
(Active Comparator)
QLAIV administered to HIV-infected individuals 2 to 25 yoa
quadrivalent live attenuated influenza vaccine FluMist Quadrivalent
(Active Comparator)
QLAIV administered to HIV-uninfected individuals 2 to 25 yoa
quadrivalent live attenuated influenza vaccine FluMist Quadrivalent

Primary Outcomes

Measure
Rate of shedding for at least one of the influenza strains included in the QLAIV at day 0 in HIV-positive and control groups.
time frame: 2-5 days
Rate of shedding for at least one of the influenza strains included in the QLAIV vaccine at days 2-5 in HIV-positive and control group.
time frame: 5 days
Rate of shedding for at least one of the influenza strains included in the QLAIV vaccine at days 7-10 in HIV-positive and control groups.
time frame: 7 days
Rate of shedding for at least one of the influenza strains included in the QLAIV at day 14-21 in HIV-positive and control groups.
time frame: 10 days

Secondary Outcomes

Measure
Proportion of adverse events between HIV-infected and HIV-uninfected subjects within 14 days after vaccination.
time frame: 14 days
Proportion of adverse events between HIV-infected and HIV-uninfected subjects between 14 and 30 days after vaccination.
time frame: 16 days
Proportion of seroconversion between HIV-positive and control groups
time frame: 14-21 days

Eligibility Criteria

Male or female participants from 2 years up to 25 years old.

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 nay experimental medication at time of immunization or planned over 21 days of shedding collection

Additional Information

Official title Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults
Principal investigator Adriana Weinberg, MD
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 we 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, we will have the opportunity to compare the immunogenicity of QLAIV, measured at baseline and 14-21 dayspost-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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Colorado, Denver.