tetano
Editor, Senior Moderator
Clin Vaccine Immunol. 2014 Oct 29. pii: CVI.00275-14. [Epub ahead of print]
Safety and Immunogenicity of a Non-Adjuvanted Vero Cell Culture-Derived Whole-Virus H9N2 Influenza Vaccine in Healthy Adults: a Phase I/II Randomized Double-Blind Study.
Aichinger G1, Grohmann-Izay B2, van der Velden MV2, Fritsch S3, Koska M3, Portsmouth D4, Hart MK5, El-Amin W5, Kistner O4, Barrett PN4.
Author information
Abstract
Studies on candidate pandemic vaccines against avian influenza virus have focussed on H5N1, but viruses of other subtypes, such as A/H9N2, are also considered to have pandemic potential. We investigated the safety and immunogenicity of two immunizations with one of five different antigen doses (ranging from 3.75 to 45 μg hemagglutinin antigen) of a non-adjuvanted, whole-virus G9-lineage H9N2 vaccine in healthy adults aged 18-49 years. Antibody responses were measured by hemagglutination inhibition (HI), microneutralization (MN) and single radial hemolysis (SRH) assays. To investigate a hypothesis that previous exposure to H2N2 viruses in subjects born in or before 1968 might prime for more robust antibody responses to H9N2 vaccination, a post-hoc age-stratified analysis of antibody responses was done. Both vaccinations in all dose groups were safe and well-tolerated. No vaccine-related serious adverse events were reported, and the majority of adverse reactions were rated as mild. Injection site reaction rates were lower in the 3.75 μg and 7.5 μg dose groups compared to the higher dose groups; systemic reaction rates were similar across all dose groups. Seroprotection rates among the different dose groups 21 days after the second immunization ranged from 52.8% to 88.9% measured by HI assay, from 88.7% to 98.1% or 82.7% to 96.2% measured by MN assay (MN titer cut-off 1:40 and 1:80, respectively), and from 94.2% to 100% measured by SRH assay. Higher antibody responses were not induced in subjects born in or before 1968. These data indicate that a non-adjuvanted, whole-virus H9N2 vaccine is well-tolerated and immunogenic in healthy adults.
Copyright ? 2014, American Society for Microbiology. All Rights Reserved.
PMID:
25355797
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/25355797
Safety and Immunogenicity of a Non-Adjuvanted Vero Cell Culture-Derived Whole-Virus H9N2 Influenza Vaccine in Healthy Adults: a Phase I/II Randomized Double-Blind Study.
Aichinger G1, Grohmann-Izay B2, van der Velden MV2, Fritsch S3, Koska M3, Portsmouth D4, Hart MK5, El-Amin W5, Kistner O4, Barrett PN4.
Author information
Abstract
Studies on candidate pandemic vaccines against avian influenza virus have focussed on H5N1, but viruses of other subtypes, such as A/H9N2, are also considered to have pandemic potential. We investigated the safety and immunogenicity of two immunizations with one of five different antigen doses (ranging from 3.75 to 45 μg hemagglutinin antigen) of a non-adjuvanted, whole-virus G9-lineage H9N2 vaccine in healthy adults aged 18-49 years. Antibody responses were measured by hemagglutination inhibition (HI), microneutralization (MN) and single radial hemolysis (SRH) assays. To investigate a hypothesis that previous exposure to H2N2 viruses in subjects born in or before 1968 might prime for more robust antibody responses to H9N2 vaccination, a post-hoc age-stratified analysis of antibody responses was done. Both vaccinations in all dose groups were safe and well-tolerated. No vaccine-related serious adverse events were reported, and the majority of adverse reactions were rated as mild. Injection site reaction rates were lower in the 3.75 μg and 7.5 μg dose groups compared to the higher dose groups; systemic reaction rates were similar across all dose groups. Seroprotection rates among the different dose groups 21 days after the second immunization ranged from 52.8% to 88.9% measured by HI assay, from 88.7% to 98.1% or 82.7% to 96.2% measured by MN assay (MN titer cut-off 1:40 and 1:80, respectively), and from 94.2% to 100% measured by SRH assay. Higher antibody responses were not induced in subjects born in or before 1968. These data indicate that a non-adjuvanted, whole-virus H9N2 vaccine is well-tolerated and immunogenic in healthy adults.
Copyright ? 2014, American Society for Microbiology. All Rights Reserved.
PMID:
25355797
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/25355797