A rapid immune response to 2009 influenza A(H1N1) vaccines in adults: a randomized, double-blind, controlled trial

J Infect Dis. 2010 Sep 1;202(5):675-80. doi: 10.1086/655226.

Abstract

A double-blind, randomized, controlled trial involving 706 adults was conducted to evaluate the immunogenicity and safety of different dosages of whole-virion or split-virion H1N1 influenza vaccines with or without aluminum adjuvant. A rapid and strong immune response was induced at day 14 after the first injection. The seroprotection rates ranged from 72.7% (95% confidence interval [CI], 62.7%-81.1%) for 5-microg whole-virion aluminum formulation to 97.0% (95% CI, 90.9%-99.7%) for 30-microg split-virion nonaluminum formulation. All formulations were well tolerated. The incidences of mild, moderate, and severe reactions were 71 (10.1%), 15 (2.1%), and 1 (0.1%) of 706 reactions, respectively. The 15-microg split-virion formulation had the best immunogenicity and safety.

Trial registration: ClinicalTrials.gov NCT00956111.

Publication types

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

MeSH terms

  • Adjuvants, Immunologic* / administration & dosage
  • Adjuvants, Immunologic* / adverse effects
  • Adolescent
  • Adult
  • Aluminum Hydroxide* / administration & dosage
  • Aluminum Hydroxide* / adverse effects
  • Aluminum Hydroxide* / immunology
  • Antibodies, Viral / blood*
  • Double-Blind Method
  • 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*
  • Influenza, Human / virology
  • Logistic Models
  • Middle Aged
  • Time Factors
  • Treatment Outcome
  • Virion / immunology
  • Young Adult

Substances

  • Adjuvants, Immunologic
  • Antibodies, Viral
  • Influenza Vaccines
  • Aluminum Hydroxide

Associated data

  • ClinicalTrials.gov/NCT00956111