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Efficacy of a bivalent killed whole-cell cholera vaccine over five years: a re-analysis of a cluster-randomized trial.

Published version
Peer-reviewed

Type

Article

Change log

Authors

Fong, Youyi 
Halloran, M Elizabeth 
Park, Jin Kyung 
Marks, Florian 
Clemens, John D 

Abstract

BACKGROUND: Oral cholera vaccine (OCV) is a feasible tool to prevent or mitigate cholera outbreaks. A better understanding of the vaccine's efficacy among different age groups and how rapidly its protection wanes could help guide vaccination policy. METHODS: To estimate the level and duration of OCV efficacy, we re-analyzed data from a previously published cluster-randomized, double-blind, placebo controlled trial with five years of follow-up. We used a Cox proportional hazards model and modeled the potentially time-dependent effect of age categories on both vaccine efficacy and risk of infection in the placebo group. In addition, we investigated the impact of an outbreak period on model estimation. RESULTS: Vaccine efficacy was 38% (95% CI: -2%,62%) for those vaccinated from ages 1 to under 5 years old, 85% (95% CI: 67%,93%) for those 5 to under 15 years, and 69% (95% CI: 49%,81%) for those vaccinated at ages 15 years and older. Among adult vaccinees, efficacy did not appear to wane during the trial, but there was insufficient data to assess the waning of efficacy among child vaccinees. CONCLUSIONS: Through this re-analysis we were able to detect a statistically significant difference in OCV efficacy when the vaccine was administered to children under 5 years old vs. children 5 years and older. The estimated efficacies are more similar to the previously published analysis based on the first two years of follow-up than the analysis based on all five years. TRIAL REGISTRATION: ClinicalTrials.gov identifier NCT00289224.

Description

Keywords

Cholera, Cluster randomized trial, Randomized control trial, Vaccination, Administration, Oral, Adolescent, Adult, Child, Child, Preschool, Cholera, Cholera Vaccines, Double-Blind Method, Female, Follow-Up Studies, Humans, Infant, Male, Placebo Effect, Proportional Hazards Models, Risk Factors, Treatment Outcome

Journal Title

BMC Infect Dis

Conference Name

Journal ISSN

1471-2334
1471-2334

Volume Title

18

Publisher

Springer Science and Business Media LLC