Improving precision of vaccine efficacy evaluation using immune correlate data in time-to-event models

Result code in IS VaVaI

<a href="https://www.isvavai.cz/riv?ss=detail&h=RIV%2F67985807%3A_____%2F24%3A00600766" target="_blank" >RIV/67985807:_____/24:00600766 - isvavai.cz</a>

Alternative codes found

RIV/00216208:11110/24:10488837

Result on the web

<a href="https://doi.org/10.1038/s41541-024-00937-6" target="_blank" >https://doi.org/10.1038/s41541-024-00937-6</a>

DOI - Digital Object Identifier

<a href="http://dx.doi.org/10.1038/s41541-024-00937-6" target="_blank" >10.1038/s41541-024-00937-6</a>

Result language

angličtina

Original language name

Improving precision of vaccine efficacy evaluation using immune correlate data in time-to-event models

Original language description

Understanding potential differences in vaccine-induced protection between demographic subgroups is key for vaccine development. Vaccine efficacy evaluation across these subgroups in phase 2b or 3 clinical trials presents challenges due to lack of precision: such trials are typically designed to demonstrate overall efficacy rather than to differentiate its value between subgroups. This study proposes a method for estimating vaccine efficacy using immunogenicity (instead of vaccination status) as a predictor in time-to-event models. The method is applied to two datasets from immunogenicity sub-studies of vaccine phase 3 clinical trials for zoster and dengue vaccines. Results show that using immunogenicity-based estimation of efficacy in subgroups using time-to-event models is more precise than the standard estimation. Incorporating immune correlate data in time-to-event models improves precision in estimating efficacy (i.e., yields narrower confidence intervals), which can assist vaccine developers and public health authorities in making informed decisions.

Czech name

—

Czech description

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Type

J_imp - Article in a specialist periodical, which is included in the Web of Science database

CEP classification

—

OECD FORD branch

30303 - Infectious Diseases

Project

—

Continuities

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Publication year

2024

Confidentiality

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

Name of the periodical

npj Vaccines

ISSN

2059-0105

e-ISSN

2059-0105

Volume of the periodical

9

Issue of the periodical within the volume

1

Country of publishing house

GB - UNITED KINGDOM

Number of pages

11

Pages from-to

214

UT code for WoS article

001352391600001

EID of the result in the Scopus database

2-s2.0-85209792852