NCT01155037

Safety of and Immunogenicity to an H1N1 Influenza Vaccine in HIV-infected Adults

Phase 2 Study to Evaluate the Safety of and the Immunogenicity to an Adjuvanted A(H1N1)v Influenza Vaccine in HIV-Infected Adults

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (actual)
• Sponsor: Oswaldo Cruz Foundation · Academic / Other
• Sex: All
• Age: 18 Years – 59 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, open label, phase II trial to evaluate the safety and immunogenicity of two different schedules of vaccination against influenza A H1N1 in HIV-infected individuals, in which each of the randomized groups will be compared with HIV-negative volunteers vaccinated with the regimen indicated by the Brazilian National Immunization Program. Will be included in the study HIV-infected patients, stratified by CD4 count (\< 200 cells/mm3 or \> 200 cells/mm3) at the time of screening for the study, not receiving antiretroviral therapy treatment or receiving stable treatment for at least 8 weeks, with no plans to change over the next 6 months, eligible to receive vaccine against influenza A H1N1. The control group will be formed by HIV-negative individuals, confirmed by serology performed at screening, eligible to receive vaccine against influenza A H1N1. Patients infected with HIV will receive one of two possible vaccination regimens: 1) 3.75 µg in two applications 21 days apart, 2) 7.5 µg in two applications 21 days apart. The volunteers in the control group will receive a single application of 3.75 µg dose of the vaccine. The study's hypotheses are: 1) The vaccine against the H1N1 virus promotes antibody titers above the level specified for protection (seroconversion), being as safe and well tolerated in patients HIV-1 infected as in non HIV-infected volunteers; 2) The proportion of seroconversion for H1N1 virus vaccine at a dose of 3.75 µg in HIV-1-infected patients is similar to the proportion of seroconversion induced by the same vaccine at a dose of 7.5 µg; 3)The proportion of seroconversion with one dose of the vaccine against H1N1 virus is similar to the proportion after the second dose.

Conditions

• HIV Infection

Interventions

Type	Name	Description
BIOLOGICAL	Adjuvanted vaccine against H1N1 influenza virus (GSK)	Patients infected with HIV will receive 3.75 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.
BIOLOGICAL	Adjuvanted vaccine against H1N1 influenza virus (GSK)	Patients infected with HIV will receive 7.5 µg of an adjuvanted A H1N1 vaccine in two applications 21 days apart.
BIOLOGICAL	Adjuvanted vaccine against H1N1 influenza virus (GSK)	Control group will receive 3.75 µg of an adjuvanted A H1N1 vaccine in one single application.

Timeline

• Start date: 2010-03-01
• Primary completion: 2012-03-01
• Completion: 2012-04-01
• First posted: 2010-07-01
• Last updated: 2018-07-18

Locations

1 site across 1 country: Brazil