Shedding, Immunogenicity and Safety of Quadrivalent Live Intranasal Influenza Vaccine (QLAIV) in HIV-infected Children and Young Adults

NCT02474901 | Completed Phase 2 Results DMC

• 1 other identifier: 13-1752
• Study Type: interventional
• Target: 101
• Locations: 1 country
• Sites: 1

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).

Conditions

Human Immunodeficiency Virus (HIV)

Keywords

Shedding; Immunogenicity; Safety; HIV infected; Children; Young adults

Outcome Measures

Primary Outcomes (2)

• 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

• 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 Outcomes (2)

• Number of Participants With Adverse Events Within 14 Days After Vaccination

  14 days after vaccination for AEs; up to 30 days for unscheduled visits

• Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups.

  14-21 days

Other Outcomes (1)

• Number of Participants With PCR-diagnosed Influenza and Clinically-diagnosed Influenza Like Illness.

  up to 11 months post-vaccination

Study Arms (2)

QLAIV, HIV-infected

ACTIVE COMPARATOR

QLAIV administered to HIV-infected individuals 2 to 25 yoa

Biological: Quadrivalent Live Attenuated Influenza Vaccine

QLAIV, HIV-uninfected

ACTIVE COMPARATOR

QLAIV administered to HIV-uninfected individuals 2 to 25 yoa

Biological: Quadrivalent Live Attenuated Influenza Vaccine

Interventions

Quadrivalent Live Attenuated Influenza Vaccine BIOLOGICAL

Also known as: FluMist Quadrivalent, QLAIV

QLAIV, HIV-infected; QLAIV, HIV-uninfected

Eligibility Criteria

• Age: 2 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Colorado, Denver: lead
• MedImmune LLC: collaborator

Study Sites (1)

University of Colorado Denver

Denver, Colorado, 80045, United States

Location

MeSH Terms

Conditions

Acquired Immunodeficiency Syndrome

Condition Hierarchy (Ancestors)

HIV Infections; Blood-Borne Infections; Communicable Diseases; Infections; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Lentivirus Infections; Retroviridae Infections; RNA Virus Infections; Virus Diseases; Slow Virus Diseases; Genital Diseases; Urogenital Diseases; Immunologic Deficiency Syndromes; Immune System Diseases

Limitations and Caveats

Data on influenza diagnosis from the end-of-season questionnaire is limited by the number of subjects who were available to answer the questionnaire (17/45 in HIV-infected group, 53/55 in HIV-uninfected group).

Results Point of Contact

• Title: Adriana Weinberg, MD
• Organization: University of Colorado

adriana.weinberg@ucdenver.edu

3037244480

Study Officials

• Adriana Weinberg, MD

  University of Colorado, Denver

  PRINCIPAL INVESTIGATOR

• Myron Levin, MD

  University of Colorado, Denver

  STUDY CHAIR

• Donna Curtis, MD,MPH

  University of Colorado, Denver

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Open label
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 15, 2015
• First Posted: June 18, 2015
• Study Start: July 1, 2013
• Primary Completion: March 1, 2016
• Study Completion: December 1, 2016
• Last Updated: November 20, 2017
• Results First Posted: October 16, 2017

Record last verified: 2017-10

Locations

US (1)