Immunogenicity of Influenza Vaccines in HIV-infected Persons in Thailand

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.

Timeline

Start

2011-11-01

Primary completion

2013-09-09

Completion

2015-10

Outcome

Missed primary endpoint

paper Percentage of seroconversion to all (ID 14% vs IM 15%; P = .8) PMID 26486702 ↗

paper Percentage of seroconversion to all (ID 14% vs IM 15%; P = .8) or at least 1 (ID 69% vs IM 68%; P = .7) PMID 26486702 ↗

Publications

• Amoah S, Mishina M, Praphasiri P, Cao W, Kim JH, Liepkalns JS, Guo Z, Carney PJ, Chang JC, Fernandez S, Garg S, Beacham L, Holtz TH, Curlin ME, Dawood F, Olsen SJ, Gangappa S, Stevens J, Sambhara S. Standard-Dose Intradermal Influenza Vaccine Elicits Cellular Immune Responses Similar to Those of Intramuscular Vaccine in Men With and Those Without HIV Infection. J Infect Dis. 2019 Jul 31;220(5):743-751. doi: 10.1093/infdis/jiz205.
• Garg S, Thongcharoen P, Praphasiri P, Chitwarakorn A, Sathirapanya P, Fernandez S, Rungrojcharoenkit K, Chonwattana W, Mock PA, Sukwicha W, Katz JM, Widdowson MA, Curlin ME, Gibbons RV, Holtz TH, Dawood FS, Olsen SJ. Randomized Controlled Trial to Compare Immunogenicity of Standard-Dose Intramuscular Versus Intradermal Trivalent Inactivated Influenza Vaccine in HIV-Infected Men Who Have Sex With Men in Bangkok, Thailand. Clin Infect Dis. 2016 Feb 1;62(3):383-391. doi: 10.1093/cid/civ884. Epub 2015 Oct 20.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Trivalent Inactivated Split Virion Influenza Vaccine	Vaccine	15 ug	Intravitreal
Subject	Trivalent Inactivated Split Virion Influenza Vaccine	Vaccine	15 ug	Intramuscular

Indications