Immunogenicity is not improved by increased antigen dose or booster dosing of seasonal influenza vaccine in a randomized trial of HIV infected adults |
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Authors: | Cooper Curtis Thorne Anona Klein Marina Conway Brian Boivin Guy Haase David Shafran Stephen Zubyk Wendy Singer Joel Halperin Scott Walmsley Sharon;CIHR Canadian HIV Trials Network Influenza Vaccine Research Group |
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Institution: | University of Ottawa Division of Infectious Diseases, Ottawa, Canada. ccooper@ottawahospital.on.ca |
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Abstract: | IntroductionThe risk of poor vaccine immunogenicity and more severe influenza disease in
HIV necessitate strategies to improve vaccine efficacy.MethodsA randomized, multi-centered, controlled, vaccine trial with three parallel
groups was conducted at 12 CIHR Canadian HIV Trials Network sites. Three
dosing strategies were used in HIV infected adults (18 to 60 years): two
standard doses over 28 days, two double doses over 28 days and a single
standard dose of influenza vaccine, administered prior to the 2008 influenza
season. A trivalent killed split non-adjuvanted influenza vaccine
(Fluviral?) was used. Serum hemagglutinin inhibition (HAI) activity
for the three influenza strains in the vaccine was measured to assess
immunogenicity.Results297 of 298 participants received at least one injection. Baseline CD4 (median
470 cells/µL) and HIV RNA (76% of patients with viral load
<50 copies/mL) were similar between groups. 89% were on HAART. The
overall immunogenicity of influenza vaccine across time points and the three
influenza strains assessed was poor (Range HAI
≥40?=?31–58%). Double dose plus double
dose booster slightly increased the proportion achieving HAI titre doubling
from baseline for A/Brisbane and B/Florida at weeks 4, 8 and 20 compared to
standard vaccine dose. Increased immunogenicity with increased antigen dose
and booster dosing was most apparent in participants with unsuppressed HIV
RNA at baseline. None of 8 serious adverse events were thought to be
immunization-related.ConclusionEven with increased antigen dose and booster dosing, non-adjuvanted influenza
vaccine immunogenicity is poor in HIV infected individuals. Alternative
influenza vaccines are required in this hyporesponsive population.Trial RegistrationClinicalTrials.gov {"type":"clinical-trial","attrs":{"text":"NCT00764998","term_id":"NCT00764998"}}NCT00764998 |
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