Safety and immunogenicity of an AS01 adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults (50 years of age)

Result code in IS VaVaI
<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60162694%3AG44__%2F13%3A43874901" target="_blank" >RIV/60162694:G44__/13:43874901 - isvavai.cz</a>
Result on the web
<a href="http://jid.oxfordjournals.org/content/208/12/1953" target="_blank" >http://jid.oxfordjournals.org/content/208/12/1953</a>
DOI - Digital Object Identifier
<a href="http://dx.doi.org/10.1093/infdis/jit365" target="_blank" >10.1093/infdis/jit365</a>

Result language
angličtina
Original language name
Safety and immunogenicity of an AS01 adjuvanted varicella-zoster virus subunit candidate vaccine against herpes zoster in adults (50 years of age)
Original language description
Background. An adjuvanted varicella-zoster virus glycoprotein E (gE) subunit vaccine candidate for herpes zoster is in development. In this trial we compared the safety, reactogenicity, and immunogenicity of the vaccine antigen combined with different adjuvant doses. Methods. This was a phase II, observer-blind, randomized, multinational study. Adults GREATER-THAN OR EQUAL TO50 years old were randomized 4:4:2:1 to be vaccinated at months 0 and 2 with gE combined with a higher (AS01B) or lower (AS01E) dose adjuvant, unadjuvanted gE, or saline. Following each dose, solicited events were recorded for 7 days and unsolicited adverse events for 30 days. Serious adverse events were collected for 1 year. Cell-mediated and humoral immune responses were assessedat baseline and following each dose. Results. No vaccine-related severe adverse events were reported. Solicited adverse events were generally mild to moderate and transient. For all gE-based vaccines, pain was the most common local sympt
Czech name
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Czech description
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Type
J<sub>x</sub> - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)
CEP classification
FN - Epidemiology, infection diseases and clinical immunology
OECD FORD branch
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Project
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Continuities
I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year
2013
Confidentiality
S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

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