Immunogenicity of a half-dose of adjuvanted 2009 pandemic H1N1 influenza vaccine in adults: a prospective cohort study

Eur J Clin Microbiol Infect Dis. 2012 Apr;31(4):591-7. doi: 10.1007/s10096-011-1352-5. Epub 2011 Jul 28.

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.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adjuvants, Immunologic / administration & dosage
  • Adult
  • Age Factors
  • Antibodies, Viral / blood
  • Cohort Studies
  • Female
  • Hemagglutination Inhibition Tests
  • Humans
  • Influenza A Virus, H1N1 Subtype / immunology*
  • Influenza Vaccines / administration & dosage*
  • Influenza Vaccines / immunology*
  • Influenza, Human / prevention & control*
  • Injections, Intramuscular
  • Male
  • Middle Aged
  • Prospective Studies

Substances

  • Adjuvants, Immunologic
  • Antibodies, Viral
  • Influenza Vaccines