Open AccessA Single-Dose Influenza A (H5N1) Vaccine Safe and Immunogenic in Adult and Elderly Patients: an Approach to Pandemic Vaccine Development
Author(s) -
Zoltán Vajó,
John M. Wood,
Lajos Kósa,
Istvan Szilvasy,
György Paragh,
Zsuzsanna Pauliny,
Kálmán Bartha,
Ildiko Visontay,
Agnes Kis,
István Jankovics
Publication year - 2010
Publication title -
journal of virology
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 2.617
H-Index - 292
eISSN - 1070-6321
pISSN - 0022-538X
DOI - 10.1128/jvi.01894-09
Subject(s) - pandemic , influenza a virus subtype h5n1 , immunogenicity , virology , live attenuated influenza vaccine , trivalent influenza vaccine , attenuated vaccine , virus , influenza a virus , influenza vaccine , immunology , inactivated vaccine , hemagglutination assay , medicine , adverse effect , reactogenicity , biology , antibody , covid-19 , virulence , titer , disease , infectious disease (medical specialty) , biochemistry , gene
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.