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

Shikha Garg, Prasert Thongcharoen, Prabda Praphasiri, Anupong Chitwarakorn, Pornchai Sathirapanya, Stefan Fernandez, Kamonthip Rungrojcharoenkit, Wannee Chonwattana, Philip A Mock, Wichuda Sukwicha, Jacqueline M Katz, Marc-Alain Widdowson, Marcel E Curlin, Robert V Gibbons, Timothy H Holtz, Fatimah S Dawood, Sonja J Olsen

Research output: Contribution to journalA1: Web of Science-article

Abstract

BACKGROUND: Individuals infected with human immunodeficiency virus (HIV) are at increased risk for severe influenza, yet immune responses to standard-dose intramuscular (IM) influenza vaccine are suboptimal in this population. Intradermal (ID) delivery of influenza vaccine might improve immune response through enhanced stimulation of dendritic cells.

METHODS: We conducted a randomized, double-blind, controlled trial to compare the immunogenicity of off-label standard-dose (15 µg) ID vs standard-dose (15 µg) IM inactive influenza vaccine in HIV-infected men in Bangkok, Thailand. The primary study outcome was seroconversion (minimum titer of 1:40 and ≥4-fold rise in antibody titer) at 1 month postvaccination based on serum hemagglutination inhibition antibody titers against each vaccine strain. Adverse events (AEs) in the 7 days following vaccination were also assessed.

RESULTS: We enrolled 400 HIV-infected participants; 200 were randomly assigned to receive IM and 200 ID vaccine. Vaccine arms were well-balanced with respect to age, CD4 cell count, HIV RNA load, and antiretroviral treatment. Percentage of seroconversion to all (ID 14% vs IM 15%; P = .8) or at least 1 (ID 69% vs IM 68%; P = .7) of the 3 vaccine strains did not differ significantly between ID vs IM vaccine recipients. A higher proportion of participants who received ID vaccine had mild injection-site AEs compared with participants who received IM vaccine (77% vs 27%).

CONCLUSIONS: There were no significant differences in the immunogenicity of standard-dose ID vs IM influenza vaccine in this HIV-infected population in Thailand. Additional strategies to enhance immune responses to influenza vaccine among HIV-infected persons are needed.

CLINICAL TRIALS REGISTRATION: NCT01538940.

Original languageEnglish
JournalClinical Infectious Diseases
Volume62
Issue number3
Pages (from-to)383-391
Number of pages9
ISSN1058-4838
DOIs
Publication statusPublished - 2016

Keywords

  • Adolescent
  • Adult
  • Antibodies, Viral/blood
  • Double-Blind Method
  • Drug-Related Side Effects and Adverse Reactions/epidemiology
  • HIV Infections/complications
  • Hemagglutination Inhibition Tests
  • Homosexuality, Male
  • Humans
  • Influenza Vaccines/administration & dosage
  • Influenza, Human/prevention & control
  • Injections, Intradermal/adverse effects
  • Injections, Intramuscular/adverse effects
  • Male
  • Middle Aged
  • Thailand
  • Treatment Outcome
  • Vaccines, Inactivated/administration & dosage
  • Young Adult

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