tetano
Editor, Senior Moderator
Hum Vaccin Immunother. 2015 Mar 9:0. [Epub ahead of print]
[h=1]Safety and immunogenicity of influenza whole inactivated virus vaccines: A phase I randomized clinical trial.[/h] Van Boxtel RA[SUP]1[/SUP], Verdijk P, De Boer OJ, Van Riet E, Mensinga TT, Luytjes W.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Influenza vaccine production capacity is still insufficient to meet global demand in case of a pandemic. To expand worldwide influenza vaccine production capacity, a solid and transferable egg-based influenza vaccine production process was established that is suitable for upscaling and technology transfer to vaccine manufacturers in low- and middle-income countries. As a proof-of concept, the safety and immunogenicity of a pandemic whole inactivated virus (WIV) vaccine (H5N1) and a monovalent seasonal WIV vaccine (H3N2) were evaluated in a phase I clinical trial in adults.
[h=4]METHODS:[/h] Subjects were vaccinated with two doses of pandemic WIV vaccine (pWIV), or one dose of either seasonal WIV vaccine (sWIV) or a commercially available trivalent comparator followed by a placebo dose. Haemagglutination inhibiting antibody titres against the influenza strains were determined before and 21 days after each vaccination.
[h=4]RESULTS:[/h] The frequency and severity of adverse reactions were comparable between groups. No serious adverse events were reported. After a single dose of sWIV the seroconversion rate was 91% (Committee for Proprietary Medicinal Products (CPMP) criterion >40%), the seroprotection rate was 100% (CPMP criterion >70%), and the mean geometric mean titre (GMT) increase was 24.9 (CPMP criterion >2.5). After two doses of pWIV, seroconversion rate and seroprotection rate were both 71%, and the mean GMT increase was 7.8.
[h=4]CONCLUSIONS:[/h] Both pWIV and sWIV were equally well-tolerated as the comparator vaccine, and both vaccines complied with all three CPMP criteria. EudraCT 2006-003448-40. Netherlands National Trial Register 2695.
[h=4]KEYWORDS:[/h] Influenza; immunogenicity; pandemic; phase I trial; safety; seasonal; whole inactivated virus vaccine
PMID: 25751506 [PubMed - as supplied by publisher]
[h=1]Safety and immunogenicity of influenza whole inactivated virus vaccines: A phase I randomized clinical trial.[/h] Van Boxtel RA[SUP]1[/SUP], Verdijk P, De Boer OJ, Van Riet E, Mensinga TT, Luytjes W.
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Influenza vaccine production capacity is still insufficient to meet global demand in case of a pandemic. To expand worldwide influenza vaccine production capacity, a solid and transferable egg-based influenza vaccine production process was established that is suitable for upscaling and technology transfer to vaccine manufacturers in low- and middle-income countries. As a proof-of concept, the safety and immunogenicity of a pandemic whole inactivated virus (WIV) vaccine (H5N1) and a monovalent seasonal WIV vaccine (H3N2) were evaluated in a phase I clinical trial in adults.
[h=4]METHODS:[/h] Subjects were vaccinated with two doses of pandemic WIV vaccine (pWIV), or one dose of either seasonal WIV vaccine (sWIV) or a commercially available trivalent comparator followed by a placebo dose. Haemagglutination inhibiting antibody titres against the influenza strains were determined before and 21 days after each vaccination.
[h=4]RESULTS:[/h] The frequency and severity of adverse reactions were comparable between groups. No serious adverse events were reported. After a single dose of sWIV the seroconversion rate was 91% (Committee for Proprietary Medicinal Products (CPMP) criterion >40%), the seroprotection rate was 100% (CPMP criterion >70%), and the mean geometric mean titre (GMT) increase was 24.9 (CPMP criterion >2.5). After two doses of pWIV, seroconversion rate and seroprotection rate were both 71%, and the mean GMT increase was 7.8.
[h=4]CONCLUSIONS:[/h] Both pWIV and sWIV were equally well-tolerated as the comparator vaccine, and both vaccines complied with all three CPMP criteria. EudraCT 2006-003448-40. Netherlands National Trial Register 2695.
[h=4]KEYWORDS:[/h] Influenza; immunogenicity; pandemic; phase I trial; safety; seasonal; whole inactivated virus vaccine
PMID: 25751506 [PubMed - as supplied by publisher]