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

Completed · Phase 2

Conditions studied: Human Immunodeficiency Virus (HIV)

In brief

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).

Key facts

Study ID

NCT02474901

Run by

University of Colorado, Denver

People needed

101

Starts

2013-07-01

Expected to finish

2016-12-01

Last updated by the study team

2017-11-20

Who can join

Age: 2 and older, up to 25. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• University of Colorado Denver — Denver, Colorado, United States

Full record on ClinicalTrials.gov

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