Giuseppe
Emeritus
J Virol. 2009 Nov 11. [Epub ahead of print]
A single-dose influenza A (H5N1) vaccine safe and immunogenic in adult and elderly patients - an approach to pandemic vaccine development.
Vajo Z, Wood J, Kosa L, Szilvasy I, Paragh G, Pauliny Z, Bartha K, Visontay I, Kis A, Jankovics I. - National Center for Allergy and Immunology, Budapest, Hungary (LK); National Institute for Biological Standards and Control (NIBSC), Potters Bar, Hertfordshire, UK (JW); National Center for Epidemiology, Budapest, Hungary (IV, IJ, ZP, KB); State Health Center, Budapest, Hungary (IS); National Institute of Pharmacy, Budapest, Hungary (AK); University of Debrecen, Hungary (ZV); National Internal Medicine Supervisor Office (GP).
Background:
With the ongoing pandemic of influenza A (H1N1) and the threat of the high fatality rates of recent human cases of highly pathogenic H5N1 strains, there has been a considerable interest of developing pandemic vaccines. Here we report a randomized multi-center dose-finding clinical trial of a whole-virion inactivated, adjuvanted H5N1 vaccine in adult and elderly volunteers.
Methods:
480 patients were randomly assigned to receive one or two doses of the vaccine of 3.5, or one dose of 6 or 12 mug. The subjects were followed for safety analysis, and serum samples were obtained to assess immunogenicity by hemagglutination inhibition and microneutralization tests.
Results:
The subjects developed antibody responses against the influenza A (H5N1) virus. Single doses >=6 mug fulfilled EU and US licensing criteria for interpandemic and pandemic influenza vaccines. Except occasional injection site pain, malaise and fever, no adverse events were observed.
Conclusions:
We found that the present vaccine is safe and immunogenic in healthy adult and elderly subjects, 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 described in this report but based on a wild type Swine-Origin 2009 A(H1N1) influenza virus isolate from the United States, supplied by the CDC is has been developed and currently being tested by the present investigators.
PMID: 19906909 [PubMed - as supplied by publisher]
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A single-dose influenza A (H5N1) vaccine safe and immunogenic in adult and elderly patients - an approach to pandemic vaccine development.
Vajo Z, Wood J, Kosa L, Szilvasy I, Paragh G, Pauliny Z, Bartha K, Visontay I, Kis A, Jankovics I. - National Center for Allergy and Immunology, Budapest, Hungary (LK); National Institute for Biological Standards and Control (NIBSC), Potters Bar, Hertfordshire, UK (JW); National Center for Epidemiology, Budapest, Hungary (IV, IJ, ZP, KB); State Health Center, Budapest, Hungary (IS); National Institute of Pharmacy, Budapest, Hungary (AK); University of Debrecen, Hungary (ZV); National Internal Medicine Supervisor Office (GP).
Background:
With the ongoing pandemic of influenza A (H1N1) and the threat of the high fatality rates of recent human cases of highly pathogenic H5N1 strains, there has been a considerable interest of developing pandemic vaccines. Here we report a randomized multi-center dose-finding clinical trial of a whole-virion inactivated, adjuvanted H5N1 vaccine in adult and elderly volunteers.
Methods:
480 patients were randomly assigned to receive one or two doses of the vaccine of 3.5, or one dose of 6 or 12 mug. The subjects were followed for safety analysis, and serum samples were obtained to assess immunogenicity by hemagglutination inhibition and microneutralization tests.
Results:
The subjects developed antibody responses against the influenza A (H5N1) virus. Single doses >=6 mug fulfilled EU and US licensing criteria for interpandemic and pandemic influenza vaccines. Except occasional injection site pain, malaise and fever, no adverse events were observed.
Conclusions:
We found that the present vaccine is safe and immunogenic in healthy adult and elderly subjects, 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 described in this report but based on a wild type Swine-Origin 2009 A(H1N1) influenza virus isolate from the United States, supplied by the CDC is has been developed and currently being tested by the present investigators.
PMID: 19906909 [PubMed - as supplied by publisher]
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