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Randomized Controlled Trial to Compare Immunogenicity of Standard Dose Intramuscular versus Intradermal Trivalent Inactivated Influenza Vaccine in HIV

tetano

Editor, Senior Moderator
Clin Infect Dis. 2015 Oct 20. pii: civ884. [Epub ahead of print]
[h=1]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.[/h] Garg S[SUP]1[/SUP], Thongcharoen P[SUP]2[/SUP], Prapasiri P[SUP]3[/SUP], Chitwarakorn A[SUP]4[/SUP], Sathirapanya P[SUP]2[/SUP], Fernandez S[SUP]5[/SUP], Rungrojcharoenkit K[SUP]5[/SUP], Chonwattana W[SUP]3[/SUP], Mock PA[SUP]3[/SUP], Sukwicha W[SUP]3[/SUP], Katz JM[SUP]6[/SUP], Widdowson MA[SUP]6[/SUP], Curlin ME[SUP]7[/SUP], Gibbons RV[SUP]5[/SUP], Holtz T[SUP]7[/SUP], Dawood FS[SUP]6[/SUP], Olsen SJ[SUP]6[/SUP].
[h=3]Author information[/h]

[h=3]Abstract[/h] [h=4]BACKGROUND:[/h]  HIV-infected persons are at increased risk for severe influenza, yet immune responses to standard dose intramuscular influenza vaccine are suboptimal in this population. Intradermal delivery of influenza vaccine might improve immune response through enhanced stimulation of dendritic cells.
[h=4]METHODS:[/h]   We conducted a randomized, double-blind, controlled trial to compare the immunogenicity of off-label standard dose (15mcg) intradermal (ID) versus standard dose (15mcg) intramuscular (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 post vaccination based on serum hemagglutination inhibition (HI) antibody titers against each vaccine strain. Adverse events in the 7 days following vaccination were also assessed.
[h=4]RESULTS:[/h]   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 viral load and antiretroviral treatment. Percent seroconversion to all (ID 14% vs. IM 15%; p=0.8) or at least one (ID 69% vs. IM 68%; p=0.7) of the three vaccine strains did not differ significantly between ID versus IM vaccine recipients. A higher proportion of participants who received ID vaccine had mild injection site adverse events compared to participants who received IM vaccine (77% versus 27%).
[h=4]CONCLUSIONS:[/h]  There were no significant differences in the immunogenicity of standard dose ID versus 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.
? The Author 2015. Published by Oxford University Press for the Infectious Diseases Society of America. All rights reserved. For permissions, e-mail journals.permissions@oup.com.


PMID: 26486702 [PubMed - as supplied by publisher]
 
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