NCT01538940

Immunogenicity of Influenza Vaccines in HIV-infected Persons in Thailand

Randomized Controlled Trial to Compare the Immunogenicity of Intramuscular Versus Intradermal Trivalent Inactivated Split Virion Influenza Vaccine in HIV-infected Men Who Have Sex With Men in Bangkok, Thailand

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 415 (actual)
• Sponsor: Centers for Disease Control and Prevention · Federal
• Sex: Male
• Age: 18 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This study will assess the efficacy of a new intradermal formulation of the trivalent inactivated influenza vaccine compared to the standard intramuscular vaccine in HIV-infected men who have sex with men in Bangkok, Thailand. Relative efficacy of the two different formulations of influenza vaccine will be assessed by comparing immunologic responses to vaccine between the two study arms.

Detailed description

This study will assess the efficacy of a new intradermal formulation of the trivalent inactivated influenza vaccine (TIV) compared to standard intramuscular TIV in HIV-infected men who have sex with men (MSM) in Bangkok, Thailand. Eligible participants will be randomized to receive standard full-dose intramuscular vaccine versus full-dose intradermal vaccine. Full dose (15 micrograms) intradermal TIV will be licensed for use in adult's ≥ 60 years of age in Thailand in mid-2011. In this study, intradermal TIV will be used off-label as the 15 microgram dose will be administered to individuals \< 60 years of age. Efficacy of the two different formulations of influenza vaccine will be assessed by comparing immunologic responses to vaccine between the two HIV-infected study arms. Both humoral (influenza antibody) and cell-mediated (influenza- specific CD4 and CD8 T cell) immune responses will be evaluated. Humoral and cell-mediated immune responses among HIV-infected individuals with CD4 cell counts less than 200 per microliter will also be compared to immune responses in HIV-infected individuals with CD4 cell counts of 200 per microliter or greater. A small HIV-uninfected MSM control group will also be enrolled (with persons randomized into either an intramuscular or intradermal TIV arm) to serve as a comparator group for the cell-mediated immunity studies.

Conditions

• Influenza

Interventions

Type	Name	Description
BIOLOGICAL	Intradermal vaccine	15ug
BIOLOGICAL	Intramuscular vaccine	15ug

Timeline

• Start date: 2011-11-01
• Primary completion: 2013-09-09
• Completion: 2015-10-01
• First posted: 2012-02-27
• Last updated: 2024-09-19

Locations

1 site across 1 country: Thailand