Abstract
We aimed to assess the immunogenicity of a single half-dose of AS03-adjuvanted monovalent 2009 pandemic H1N1 vaccine in healthy adults. Healthy subjects age 20–60 years were prospectively enrolled in a cohort receiving intramuscular administration of a single half-dose (1.875 μg of hemagglutinin [HA]) of adjuvanted 2009 pandemic H1N1 influenza vaccine. Data from participants enrolled in a concomitant study of immunogenicity following a full-dose (3.75 μg of HA) are presented concurrently. Sera for assessment of hemagglutination-inhibiting (HAI) antibody to the vaccine strain were obtained before and 14 or 21 days after vaccination. Ninety-seven participants received a half-dose and 50 received a full-dose of vaccine. In the half-dose cohort, Food and Drug Administration criteria for immunogenicity regarding seroprotection and seroconversion rates were met for subjects aged 20–45 years, but not for those aged 46–60 years. There was no statistically significant difference in the proportion of individuals achieving a post-vaccination HAI titre of ≥1:40, the geometric mean titres of post-vaccination antibody, or the proportion of individuals with a four-fold or greater increase in antibody levels between the two cohorts. Participants 46–60 years of age were significantly less likely to be seroprotected at day 21 than those 20–45 years old in both cohorts. Immunogenicity of a half dose of adjuvanted pH1N1 influenza vaccine was adequate in subjects aged 20–45 years. Dose reduction is a possible strategy for expanding the availability in the event of vaccine shortage in this age group.
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Acknowledgements
The authors wish to thank the staff of the Public Health Laboratory, Ontario Agency of Health Protection and Promotion, for their assistance with this study.
Financial disclosure
This project was supported by a research fellowship of the Swiss National Science Foundation (grant number PBZHP3-125576, http://www.snf.ch/E/Pages/default.aspx) to SPK. The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.
Competing interests
AM has investigator-initiated research studies funded by GlaxoSmithKline Ltd. and Sanofi Pasteur, both of which manufacture vaccines. All other authors report no conflicts.
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Coleman, B.L., Kuster, S.P., Gubbay, J. et al. Immunogenicity of a half-dose of adjuvanted 2009 pandemic H1N1 influenza vaccine in adults: a prospective cohort study. Eur J Clin Microbiol Infect Dis 31, 591–597 (2012). https://doi.org/10.1007/s10096-011-1352-5
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DOI: https://doi.org/10.1007/s10096-011-1352-5