Safety and immunogenicity of influenza A H5 subunit vaccines: Effect of vaccine schedule and antigenic variant

Robert B. Belshe, Sharon E. Frey, Irene Graham, Mark J. Mulligan, Srilatha Edupuganti, Lisa A. Jackson, Anna Wald, Gregory Poland, Robert Jacobson, Harry L. Keyserling, Paul Spearman, Heather Hill, Mark Wolff

Research output: Contribution to journalArticlepeer-review

44 Scopus citations

Abstract

Background. The current US national stockpile of influenza H5 vaccine was produced using the antigen from the strain A/Vietnam/1203/2004 (a clade 1 H5 virus). Recent H5 disease has been caused by antigenically divergent H5 viruses, including A/Indonesia/05/2005 (a clade 2 H5 virus). Methods. The influence of schedule on the antibody response to 2 doses of H5 vaccines (one a clade 1 hemagglutinin protein [HA] vaccine and one a clade 2 HA vaccine) containing 90 lg of antigen was evaluated in healthy adults 18-49 years of age. Results. Two doses of vaccine were required to induce antibody titers ≥1:10 in most subjects. Accelerated schedules were immunogenic, and antibody developed after vaccinations on days 0 and 7, 0 and 14, and 0 and 28, with the day 0 and 7 schedule inducing lower titers than those induced with the other schedules. With mixed vaccine schedules of clade 1 followed by clade 2 vaccine administration, the first vaccination primed for a heterologous boost. The heterologous response was improved when the second vaccination was given 6 months after the first, compared with the response when the second vaccination was given after an interval of 1 month. Conclusions. An accelerated vaccine schedule of injections administered at days 0 and 14 was as immunogenic as a vaccine schedule of injections at days 0 and 28, but both schedules were inferior to a vaccine schedule of injections administered at 0 and 6 months for priming for heterologous vaccine boosting. Clinical Trial Registry Number: NCT00703053.

Original languageEnglish (US)
Pages (from-to)666-673
Number of pages8
JournalJournal of Infectious Diseases
Volume203
Issue number5
DOIs
StatePublished - Mar 1 2011

ASJC Scopus subject areas

  • Immunology and Allergy
  • Infectious Diseases

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