tetano
Editor, Senior Moderator
J Infect Dis. 2016 Sep 7. pii: jiw414. [Epub ahead of print]
[h=1]Immunogenicity and safety of an AS03-adjuvanted H7N9 pandemic influenza vaccine in a randomized trial in healthy adults.[/h] Madan A[SUP]1[/SUP], Segall N[SUP]2[/SUP], Ferguson M[SUP]3[/SUP], Frenette L[SUP]4[/SUP], Kroll R[SUP]5[/SUP], Friel D[SUP]6[/SUP], Soni J[SUP]7[/SUP], Li P[SUP]8[/SUP], Innis BL[SUP]8[/SUP], Schuind A[SUP]8[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Almost 700 cases of human infection with avian influenza A/H7N9 have been reported since 2013. Pandemic preparedness strategies include H7N9 vaccine development.
[h=4]METHODS:[/h] We evaluated an inactivated H7N9 vaccine in an observer-blind study in healthy adults aged 18-64 years (NCT01999842). Participants were randomized to receive one of four AS03-adjuvanted vaccines (low or medium dose of hemagglutinin with AS03A or AS03B), one non-adjuvanted vaccine or placebo. The co-primary immunogenicity objective determined whether adjuvanted vaccines elicited an immune response against the vaccine-homologous virus, 21 days after the second vaccine dose per US and European licensure criteria in the per-protocol cohort (N=389).
[h=4]RESULTS:[/h] All adjuvanted vaccines met regulatory acceptance criteria. In groups receiving adjuvanted formulations, seroconversion rates were ≥85.7%, seroprotection rates ≥91.1%, and geometric mean titers ≥92.9 vs. 23.2%, 28.6%, and 17.2 for the non-adjuvanted vaccine. The AS03 adjuvant enhanced immune response at antigen-sparing doses. Injection site pain occurred more frequently with adjuvanted vaccines (in ≤98.3% of vaccinees) than with the non-adjuvanted vaccine (40.7%) or placebo (20.0%). None of the 20 serious adverse events reported were related to vaccination.
[h=4]CONCLUSIONS:[/h] Two doses of AS03-adjuvanted H7N9 vaccine were well tolerated and induced a robust antibody response at antigen-sparing doses in healthy adults.
? The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.
PMID: 27609809 DOI: 10.1093/infdis/jiw414
[PubMed - as supplied by publisher]
[h=1]Immunogenicity and safety of an AS03-adjuvanted H7N9 pandemic influenza vaccine in a randomized trial in healthy adults.[/h] Madan A[SUP]1[/SUP], Segall N[SUP]2[/SUP], Ferguson M[SUP]3[/SUP], Frenette L[SUP]4[/SUP], Kroll R[SUP]5[/SUP], Friel D[SUP]6[/SUP], Soni J[SUP]7[/SUP], Li P[SUP]8[/SUP], Innis BL[SUP]8[/SUP], Schuind A[SUP]8[/SUP].
[h=3]Author information[/h]
[h=3]Abstract[/h] [h=4]BACKGROUND:[/h] Almost 700 cases of human infection with avian influenza A/H7N9 have been reported since 2013. Pandemic preparedness strategies include H7N9 vaccine development.
[h=4]METHODS:[/h] We evaluated an inactivated H7N9 vaccine in an observer-blind study in healthy adults aged 18-64 years (NCT01999842). Participants were randomized to receive one of four AS03-adjuvanted vaccines (low or medium dose of hemagglutinin with AS03A or AS03B), one non-adjuvanted vaccine or placebo. The co-primary immunogenicity objective determined whether adjuvanted vaccines elicited an immune response against the vaccine-homologous virus, 21 days after the second vaccine dose per US and European licensure criteria in the per-protocol cohort (N=389).
[h=4]RESULTS:[/h] All adjuvanted vaccines met regulatory acceptance criteria. In groups receiving adjuvanted formulations, seroconversion rates were ≥85.7%, seroprotection rates ≥91.1%, and geometric mean titers ≥92.9 vs. 23.2%, 28.6%, and 17.2 for the non-adjuvanted vaccine. The AS03 adjuvant enhanced immune response at antigen-sparing doses. Injection site pain occurred more frequently with adjuvanted vaccines (in ≤98.3% of vaccinees) than with the non-adjuvanted vaccine (40.7%) or placebo (20.0%). None of the 20 serious adverse events reported were related to vaccination.
[h=4]CONCLUSIONS:[/h] Two doses of AS03-adjuvanted H7N9 vaccine were well tolerated and induced a robust antibody response at antigen-sparing doses in healthy adults.
? The Author 2016. Published by Oxford University Press for the Infectious Diseases Society of America.
PMID: 27609809 DOI: 10.1093/infdis/jiw414
[PubMed - as supplied by publisher]