Phase 2 Completed N=101 Health Services Research

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

HIV

Source: ClinicalTrials.gov NCT02474901 ↗

Enrolled (actual)

101

Serious AEs

1.0%

Results posted

Oct 2017

Primary outcomePrimary: 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. — 0; 0; 30; 28 Participants

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).

Outcome Measures

Outcome	Result	p-value
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.	0; 0; 30; 28	—
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.	0; 0; 30; 27; 13; 11	—
SECONDARY Number of Participants With Adverse Events Within 14 Days After Vaccination	0; 1; 17; 16; 17; 16	<0.05 sig
SECONDARY Number of Participants Reaching Seroprotection (HAI ≥ 40) Within the HIV-positive and Control Groups.	35; 35; 27; 35; 7; 4	—

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02474901). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.