tetano
Editor, Senior Moderator
Clin Vaccine Immunol. 2014 Apr 16. [Epub ahead of print]
Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus H5N1 Influenza Vaccine in Chronically Ill and Immunocompromised Patients.
van der Velden MV1, Geisberger A, Dvorak T, Portsmouth D, Fritz R, Crowe BA, Herr W, Distler E, Wagner EM, Zeitlinger M, Sauermann R, Stephan C, Ehrlich HJ, Barrett PN, Aichinger G.
Author information
Abstract
The development of vaccines against H5N1 influenza viruses is a cornerstone of pandemic preparedness. Clinical trials of H5N1 vaccines have been undertaken in healthy subjects but studies in risk groups are lacking. In this study, the immunogenicity and safety of a non-adjuvanted cell culture-derived whole-virus H5N1 vaccine was assessed in chronically ill and immunocompromised adults. Subjects received two priming immunizations with a clade 1 A/Vietnam H5N1 vaccine and a subset also received a booster immunization with a clade 2.1 A/Indonesia H5N1 vaccine 12-24 months later. Antibody responses in both populations were assessed by virus neutralization and single radial haemolysis assay. T-cell responses in a subset of immunocompromised patients were assessed by ELISPOT. Both priming and booster vaccinations were safe and well-tolerated in both risk populations and adverse reactions were predominantly mild and transient. Priming immunizations induced neutralizing antibody titers ≥1:20 against the A/Vietnam strain in 64.2% of chronically ill and 41.5% of immunocompromised subjects. After the booster vaccination, 77.5% and 70.8% of chronically ill subjects, and 71.6% and 67.5% of immunocompromised subjects achieved neutralizing antibody titers ≥1:20 against the A/Vietnam and A/Indonesia strains, respectively. T-cell responses against both H5N1 strains increased significantly compared to baseline. Substantial heterosubtypic T-cell responses were elicited against the 2009 pandemic H1N1 virus and seasonal H1N1, H3N2 and B subtypes. There was a significant correlation between T-cell responses and neutralizing antibody titers. These data indicate that non-adjuvanted whole-virus cell culture-derived H5N1 influenza vaccines are suitable for immunization of chronically ill and immunocompromised populations.
PMID:
24739978
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24739978
Safety and Immunogenicity of a Vero Cell Culture-Derived Whole-Virus H5N1 Influenza Vaccine in Chronically Ill and Immunocompromised Patients.
van der Velden MV1, Geisberger A, Dvorak T, Portsmouth D, Fritz R, Crowe BA, Herr W, Distler E, Wagner EM, Zeitlinger M, Sauermann R, Stephan C, Ehrlich HJ, Barrett PN, Aichinger G.
Author information
Abstract
The development of vaccines against H5N1 influenza viruses is a cornerstone of pandemic preparedness. Clinical trials of H5N1 vaccines have been undertaken in healthy subjects but studies in risk groups are lacking. In this study, the immunogenicity and safety of a non-adjuvanted cell culture-derived whole-virus H5N1 vaccine was assessed in chronically ill and immunocompromised adults. Subjects received two priming immunizations with a clade 1 A/Vietnam H5N1 vaccine and a subset also received a booster immunization with a clade 2.1 A/Indonesia H5N1 vaccine 12-24 months later. Antibody responses in both populations were assessed by virus neutralization and single radial haemolysis assay. T-cell responses in a subset of immunocompromised patients were assessed by ELISPOT. Both priming and booster vaccinations were safe and well-tolerated in both risk populations and adverse reactions were predominantly mild and transient. Priming immunizations induced neutralizing antibody titers ≥1:20 against the A/Vietnam strain in 64.2% of chronically ill and 41.5% of immunocompromised subjects. After the booster vaccination, 77.5% and 70.8% of chronically ill subjects, and 71.6% and 67.5% of immunocompromised subjects achieved neutralizing antibody titers ≥1:20 against the A/Vietnam and A/Indonesia strains, respectively. T-cell responses against both H5N1 strains increased significantly compared to baseline. Substantial heterosubtypic T-cell responses were elicited against the 2009 pandemic H1N1 virus and seasonal H1N1, H3N2 and B subtypes. There was a significant correlation between T-cell responses and neutralizing antibody titers. These data indicate that non-adjuvanted whole-virus cell culture-derived H5N1 influenza vaccines are suitable for immunization of chronically ill and immunocompromised populations.
PMID:
24739978
[PubMed - as supplied by publisher]
http://www.ncbi.nlm.nih.gov/pubmed/24739978