A single-dose influenza a (H5N1) vaccine safe and immunogenic in adult and elderly patients

An approach to pandemic vaccine development

Z. Vajó, John Wood, Lajos Kosa, Istvan Szilvasy, G. Paragh, Zsuzsanna Pauliny, Kálmán Bartha, Ildiko Visontay, Agnes Kis, Istvan Jankovics

Research output: Contribution to journalArticle

18 Citations (Scopus)

Abstract

With the ongoing pandemic of influenza A (H1N1) virus infection and the threat of high fatality rates for recent human cases of infection with highly pathogenic H5N1 strains, there has been considerable interest in developing pandemic vaccines. Here we report a randomized multicenter dose-finding clinical trial of a whole-virion, inactivated, adjuvanted H5N1 vaccine in adult and elderly volunteers. Four hundred eighty patients were randomly assigned to receive one or two doses of 3.5 μg of the vaccine or one dose of 6 or 12 μg. The subjects were monitored for safety analysis, and serum samples were obtained to assess immunogenicity by hemagglutination inhibition and microneutralization tests. The subjects developed antibody responses against the influenza A (H5N1) virus. Single doses of ≥6 μg fulfilled EU and U.S. licensing criteria for interpandemic and pandemic influenza vaccines. Except for occasional injection site pain, malaise, and fever, no adverse events were observed. We found that the present vaccine is safe and immunogenic in healthy adult and elderly subjects and requires low doses and, unlike any other H5N1 vaccines, only one injection to trigger immune responses which comply with licensing criteria. A vaccine using the same methods as those described in this report, but based on a wild-type swine-origin 2009 (H1N1) influenza A virus isolate from the United States (supplied by the CDC), has been developed and is currently being tested by our group.

Original languageEnglish
Pages (from-to)1237-1242
Number of pages6
JournalJournal of Virology
Volume84
Issue number3
DOIs
Publication statusPublished - Feb 2010

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vaccine development
Pandemics
pandemic
influenza
Human Influenza
Vaccines
vaccines
dosage
Influenza A virus
H1N1 Subtype Influenza A Virus
Licensure
H5N1 Subtype Influenza A Virus
Hemagglutination Inhibition Tests
immune response
Injections
Influenza Vaccines
Virus Diseases
Centers for Disease Control and Prevention (U.S.)
safety assessment
injection site

ASJC Scopus subject areas

  • Immunology
  • Virology

Cite this

A single-dose influenza a (H5N1) vaccine safe and immunogenic in adult and elderly patients : An approach to pandemic vaccine development. / Vajó, Z.; Wood, John; Kosa, Lajos; Szilvasy, Istvan; Paragh, G.; Pauliny, Zsuzsanna; Bartha, Kálmán; Visontay, Ildiko; Kis, Agnes; Jankovics, Istvan.

In: Journal of Virology, Vol. 84, No. 3, 02.2010, p. 1237-1242.

Research output: Contribution to journalArticle

Vajó, Z. ; Wood, John ; Kosa, Lajos ; Szilvasy, Istvan ; Paragh, G. ; Pauliny, Zsuzsanna ; Bartha, Kálmán ; Visontay, Ildiko ; Kis, Agnes ; Jankovics, Istvan. / A single-dose influenza a (H5N1) vaccine safe and immunogenic in adult and elderly patients : An approach to pandemic vaccine development. In: Journal of Virology. 2010 ; Vol. 84, No. 3. pp. 1237-1242.
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