NCT02474901

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 101 (actual)
• Sponsor: University of Colorado, Denver · Academic / Other
• Sex: All
• Age: 2 Years – 25 Years
• Healthy volunteers: Accepted

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.

Conditions

• Human Immunodeficiency Virus (HIV)

Interventions

Type	Name	Description
BIOLOGICAL	Quadrivalent Live Attenuated Influenza Vaccine

Timeline

• Start date: 2013-07-01
• Primary completion: 2016-03-01
• Completion: 2016-12-01
• First posted: 2015-06-18
• Last updated: 2017-11-20
• Results posted: 2017-10-16

Locations

1 site across 1 country: United States