Response to a Monovalent 2009 Influenza A (H1N1) Vaccine

N Engl J Med. 2009 Dec 17;361(25):2405-13. doi: 10.1056/NEJMoa0907413. Epub 2009 Sep 10.

Abstract

Background: A novel 2009 influenza A (H1N1) virus is responsible for the first influenza pandemic in 41 years. A safe and effective vaccine is needed. A randomized, observer-blind, parallel-group trial evaluating two doses of an inactivated, split-virus 2009 H1N1 vaccine in healthy adults between the ages of 18 and 64 years is ongoing at a single site in Australia.

Methods: We evaluated the immunogenicity and safety of the vaccine after each of two scheduled doses, administered 21 days apart. A total of 240 subjects, equally divided into two age groups (<50 years and >or=50 years), were enrolled and underwent randomization to receive either 15 microg or 30 microg of hemagglutinin antigen by intramuscular injection. We measured antibody titers using hemagglutination-inhibition and microneutralization assays at baseline and 21 days after vaccination. The coprimary immunogenicity end points were the proportion of subjects with antibody titers of 1:40 or more on hemagglutination-inhibition assay, the proportion of subjects with either seroconversion or a significant increase in antibody titer, and the factor increase in the geometric mean titer.

Results: By day 21 after the first dose, antibody titers of 1:40 or more were observed in 114 of 120 subjects (95.0%) who received the 15-microg dose and in 106 of 119 subjects (89.1%) who received the 30-microg dose. A similar result was observed after the second dose of vaccine. No deaths, serious adverse events, or adverse events of special interest were reported. Local discomfort (e.g., injection-site tenderness or pain) was reported by 56.3% of subjects, and systemic symptoms (e.g., headache) by 53.8% of subjects after each dose. Nearly all events were mild to moderate in intensity.

Conclusions: A single 15-microg dose of 2009 H1N1 vaccine was immunogenic in adults, with mild-to-moderate vaccine-associated reactions. (ClinicalTrials.gov number, NCT00938639).

Publication types

  • Clinical Trial, Phase II
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Antibodies, Viral / blood*
  • Female
  • Hemagglutination Inhibition Tests
  • Humans
  • Influenza A Virus, H1N1 Subtype / immunology*
  • Influenza Vaccines / administration & dosage
  • Influenza Vaccines / adverse effects
  • Influenza Vaccines / immunology*
  • Influenza, Human / immunology*
  • Influenza, Human / prevention & control
  • Male
  • Middle Aged
  • Neutralization Tests
  • Prospective Studies
  • Single-Blind Method
  • Young Adult

Substances

  • Antibodies, Viral
  • Influenza Vaccines

Associated data

  • ClinicalTrials.gov/NCT00938639