A unified evaluation of differential vaccine efficacy.
Biometrics
; 76(4): 1053-1063, 2020 12.
Article
em En
| MEDLINE
| ID: mdl-31868914
ABSTRACT
Many infectious diseases are well prevented by proper vaccination. However, when a vaccine is not completely efficacious, there is great interest in determining how the vaccine effect differs in subgroups conditional on measured immune responses postvaccination and also according to the type of infecting agent (eg, strain of a virus). The former is often called correlate of protection (CoP) analysis, while the latter has been called sieve analysis. We propose a unified framework for simultaneously assessing CoP and sieve effects of a vaccine in a large Phase III randomized trial. We use flexible parametric models treating times to infection from different agents as competing risks and estimated maximum likelihood to fit the models. The parametric models under competing risks allow for estimation of both cumulative incidence-based contrasts and instantaneous rates. We outline the assumptions with which we can link the observable data to the causal contrasts of interest, propose hypothesis testing procedures, and evaluate our proposed methods in an extensive simulation study.
Palavras-chave
Texto completo:
1
Coleções:
01-internacional
Base de dados:
MEDLINE
Assunto principal:
Vacinas
Tipo de estudo:
Clinical_trials
/
Incidence_studies
/
Prognostic_studies
Idioma:
En
Revista:
Biometrics
Ano de publicação:
2020
Tipo de documento:
Article
País de afiliação:
Suécia