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

Kód výsledku v 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>

Nalezeny alternativní kódy

RIV/00216208:11110/24:10488837

Výsledek na webu

<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>

Jazyk výsledku

angličtina

Název v původním jazyce

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

Popis výsledku v původním jazyce

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.

Název v anglickém jazyce

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

Popis výsledku anglicky

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.

Druh

J_imp - Článek v periodiku v databázi Web of Science

CEP obor

—

OECD FORD obor

30303 - Infectious Diseases

Projekt

—

Návaznosti

I - Institucionalni podpora na dlouhodoby koncepcni rozvoj vyzkumne organizace

Rok uplatnění

2024

Kód důvěrnosti údajů

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

Název periodika

npj Vaccines

ISSN

2059-0105

e-ISSN

2059-0105

Svazek periodika

9

Číslo periodika v rámci svazku

1

Stát vydavatele periodika

GB - Spojené království Velké Británie a Severního Irska

Počet stran výsledku

11

Strana od-do

214

Kód UT WoS článku

001352391600001

EID výsledku v databázi Scopus

2-s2.0-85209792852