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

Kód výsledku v 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>

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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

Název v anglickém jazyce

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

Popis výsledku anglicky

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

Druh

J_x - Nezařazeno - Článek v odborném periodiku (Jimp, Jsc a Jost)

CEP obor

FN - Epidemiologie, infekční nemoci a klinická imunologie

OECD FORD obor

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Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2013

Kód důvěrnosti údajů

S - Úplné a pravdivé údaje o projektu nepodléhají ochraně podle zvláštních právních předpisů

Název periodika

Journal of Infectious Diseases

ISSN

0022-1899

e-ISSN

—

Svazek periodika

12

Číslo periodika v rámci svazku

208

Stát vydavatele periodika

US - Spojené státy americké

Počet stran výsledku

9

Strana od-do

1953-1961

Kód UT WoS článku

000327544600005

EID výsledku v databázi Scopus

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