Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F60162694%3AG44__%2F15%3A43875382" target="_blank" >RIV/60162694:G44__/15:43875382 - isvavai.cz</a>

Result on the web

<a href="http://www.nejm.org/doi/full/10.1056/NEJMoa1501184" target="_blank" >http://www.nejm.org/doi/full/10.1056/NEJMoa1501184</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1056/NEJMoa1501184" target="_blank" >10.1056/NEJMoa1501184</a>

Result language

angličtina

Original language name

Efficacy of an adjuvanted herpes zoster subunit vaccine in older adults

Original language description

In previous phase 1-2 clinical trials involving older adults, a subunit vaccine containing varicella-zoster virus glycoprotein E and the AS01(B) adjuvant system (called HZ/su) had a clinically acceptable safety profile and elicited a robust immune response. We conducted a randomized, placebo-controlled, phase 3 study in 18 countries to evaluate the efficacy and safety of HZ/su in older adults (}= 50 years of age), stratified according to age group (50 to 59, 60 to 69, and }= 70 years). Participants received two intramuscular doses of the vaccine or placebo 2 months apart. The primary objective was to assess the efficacy of the vaccine, as compared with placebo, in reducing the risk of herpes zoster in older adults. A total of 15,411 participants who could be evaluated received either the vaccine (7698 participants) or placebo (7713 participants). During a mean follow-up of 3.2 years, herpes zoster was confirmed in 6 participants in the vaccine group and in 210 participants in the placebo group (incidence rate, 0.3 vs. 9.1 per 1000 person-years) in the modified vaccinated cohort. Overall vaccine efficacy against herpes zoster was 97.2% (95% confidence interval [CI], 93.7 to 99.0; P<0.001). Vaccine efficacy was between 96.6% and 97.9% for all age groups. Solicited reports of injection-site and systemic reactions within 7 days after vaccination were more frequent in the vaccine group. There were solicited or unsolicited reports of grade 3 symptoms in 17.0% of vaccine recipients and 3.2% of placebo recipients. The proportions of participants who had serious adverse events or potential immune-mediated diseases or who died were similar in the two groups.The HZ/su vaccine significantly reduced the risk of herpes zoster in adults who were 50 years of age or older. Vaccine efficacy in adults who were 70 years of age or older was similar to that in the other two age groups. (Funded by GlaxoSmithKline Biologicals; ZOE-50 ClinicalTrials.govnumber, NCT01165177.)

Czech name

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Czech description

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Type

J_x - Unclassified - Peer-reviewed scientific article (Jimp, Jsc and Jost)

CEP classification

EE - Microbiology, virology

OECD FORD branch

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Project

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Continuities

N - Vyzkumna aktivita podporovana z neverejnych zdroju

Publication year

2015

Confidentiality

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

Name of the periodical

New England Journal of Medicine

ISSN

0028-4793

e-ISSN

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Volume of the periodical

372

Issue of the periodical within the volume

22

Country of publishing house

US - UNITED STATES

Number of pages

10

Pages from-to

2087-2096

UT code for WoS article

000355146800004

EID of the result in the Scopus database

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