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 Curlin, Robert V. Gibbons, Timothy H. Holtz, Fatimah S. Dawood, Sonja J. Olsen

Research output: Contribution to journalArticle

3 Citations (Scopus)

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.

Original languageEnglish (US)
Pages (from-to)383-391
Number of pages9
JournalClinical Infectious Diseases
Volume62
Issue number3
DOIs
StatePublished - Feb 1 2016
Externally publishedYes

Fingerprint

Inactivated Vaccines
Influenza Vaccines
Thailand
Human Influenza
Vaccines
Randomized Controlled Trials
HIV
Antibodies
Hemagglutination
CD4 Lymphocyte Count
Dendritic Cells
Population
Vaccination
Outcome Assessment (Health Care)
RNA
Injections
Serum

Keywords

  • HIV
  • immunogenicity
  • influenza
  • intradermal
  • vaccine

ASJC Scopus subject areas

  • Infectious Diseases
  • Microbiology (medical)

Cite this

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

In: Clinical Infectious Diseases, Vol. 62, No. 3, 01.02.2016, p. 383-391.

Research output: Contribution to journalArticle

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, M, Gibbons, RV, Holtz, TH, Dawood, FS & Olsen, SJ 2016, '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', Clinical Infectious Diseases, vol. 62, no. 3, pp. 383-391. https://doi.org/10.1093/cid/civ884
Garg, Shikha ; Thongcharoen, Prasert ; Praphasiri, Prabda ; Chitwarakorn, Anupong ; Sathirapanya, Pornchai ; Fernandez, Stefan ; Rungrojcharoenkit, Kamonthip ; Chonwattana, Wannee ; Mock, Philip A. ; Sukwicha, Wichuda ; Katz, Jacqueline M. ; Widdowson, Marc Alain ; Curlin, Marcel ; Gibbons, Robert V. ; Holtz, Timothy H. ; Dawood, Fatimah S. ; Olsen, Sonja J. / 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. In: Clinical Infectious Diseases. 2016 ; Vol. 62, No. 3. pp. 383-391.
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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.",
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AU - Garg, Shikha

AU - Thongcharoen, Prasert

AU - Praphasiri, Prabda

AU - Chitwarakorn, Anupong

AU - Sathirapanya, Pornchai

AU - Fernandez, Stefan

AU - Rungrojcharoenkit, Kamonthip

AU - Chonwattana, Wannee

AU - Mock, Philip A.

AU - Sukwicha, Wichuda

AU - Katz, Jacqueline M.

AU - Widdowson, Marc Alain

AU - Curlin, Marcel

AU - Gibbons, Robert V.

AU - Holtz, Timothy H.

AU - Dawood, Fatimah S.

AU - Olsen, Sonja J.

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N2 - 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.

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