tetano
Editor, Senior Moderator
Clin Vaccine Immunol. 2012 Oct 17. [Epub ahead of print]
Assessment of Antigen-Specific and Cross-Reactive Antibody Responses to an MF59(R)-Adjuvanted, A/H5N1, Pre-Pandemic Influenza Vaccine in Adult and Elderly Subjects.
Bihari I, P?ncz?l G, Kovacs J, Beygo J, Fragapane E.
Source
Pestszentlőrinc-Pestszentimre Health Service KFT, Budapest, Hungary.
Abstract
Background: Preparedness against an A/H5N1 influenza pandemic requires well-tolerated, effective vaccines which provide both vaccine strain-specific and heterologous, cross-clade protection. This study was conducted to assess the immunogenicity and safety profile of an MF59?-adjuvanted, pre-pandemic influenza vaccine containing A/turkey/Turkey/01/2005 (H5N1) strain viral antigen.Methods: A total of 343 participants, 194 adults (18-60 years) and 149 elderly individuals (≥61 years), received two doses of the investigational vaccine given three weeks apart. Homologous and heterologous antibody responses were analysed by haemagglutination inhibition (HI), single radial haemolysis (SRH), and microneutralization (MN) assays three weeks after administration of the first vaccine dose, and three weeks and 6 months after the second dose. Immunogenicity was assessed according to European licensure criteria for pandemic influenza vaccines.Results: After two vaccine doses, all three European licensure criteria were met for adult and elderly subjects against the homologous vaccine strain, A/turkey/Turkey/1/2005, when analysed by HI and SRH assays. Cross-reactive antibody responses were observed by HI and SRH analyses against the heterologous H5N1 strains, A/Indonesia/5/2005 and A/Vietnam/1194/2004, in adult and elderly subjects. Solicited local and systemic reactions were mostly mild to moderate in severity, and occurred less frequently in the elderly compared with adult vaccinees.Conclusion: In both adult and elderly subjects, MF59-adjuvanted vaccine containing 7.5 μg of A/Turkey strain influenza antigen was highly immunogenic, well-tolerated, and able to elicit cross-clade, heterologous antibody responses against A/Indonesia and A/Vietnam strains six weeks after first vaccination.Trial registration: (www.clincialtrials.gov) NCT00841646.
PMID:
23081815
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23081815
Assessment of Antigen-Specific and Cross-Reactive Antibody Responses to an MF59(R)-Adjuvanted, A/H5N1, Pre-Pandemic Influenza Vaccine in Adult and Elderly Subjects.
Bihari I, P?ncz?l G, Kovacs J, Beygo J, Fragapane E.
Source
Pestszentlőrinc-Pestszentimre Health Service KFT, Budapest, Hungary.
Abstract
Background: Preparedness against an A/H5N1 influenza pandemic requires well-tolerated, effective vaccines which provide both vaccine strain-specific and heterologous, cross-clade protection. This study was conducted to assess the immunogenicity and safety profile of an MF59?-adjuvanted, pre-pandemic influenza vaccine containing A/turkey/Turkey/01/2005 (H5N1) strain viral antigen.Methods: A total of 343 participants, 194 adults (18-60 years) and 149 elderly individuals (≥61 years), received two doses of the investigational vaccine given three weeks apart. Homologous and heterologous antibody responses were analysed by haemagglutination inhibition (HI), single radial haemolysis (SRH), and microneutralization (MN) assays three weeks after administration of the first vaccine dose, and three weeks and 6 months after the second dose. Immunogenicity was assessed according to European licensure criteria for pandemic influenza vaccines.Results: After two vaccine doses, all three European licensure criteria were met for adult and elderly subjects against the homologous vaccine strain, A/turkey/Turkey/1/2005, when analysed by HI and SRH assays. Cross-reactive antibody responses were observed by HI and SRH analyses against the heterologous H5N1 strains, A/Indonesia/5/2005 and A/Vietnam/1194/2004, in adult and elderly subjects. Solicited local and systemic reactions were mostly mild to moderate in severity, and occurred less frequently in the elderly compared with adult vaccinees.Conclusion: In both adult and elderly subjects, MF59-adjuvanted vaccine containing 7.5 μg of A/Turkey strain influenza antigen was highly immunogenic, well-tolerated, and able to elicit cross-clade, heterologous antibody responses against A/Indonesia and A/Vietnam strains six weeks after first vaccination.Trial registration: (www.clincialtrials.gov) NCT00841646.
PMID:
23081815
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/23081815