Evidence map›Paper›PMID 29463233›Full record

Trial reportBMC infectious diseases2018

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

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

Registry-linked trialAbstract readRandomized Controlled Trial
In one paragraph

Trial report in BMC infectious diseases, 2018. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00289224 (A Randomized Controlled Trial of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India), which is not on this map. Cited by 13 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
13citing papers in PubMed, 2 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00289224 phase3completednot on this map

A Randomized Controlled Trial of the Bivalent Killed Whole Cell Oral Cholera Vaccine in Eastern Kolkata, West Bengal, India

TypeinterventionalSponsorInternational Vaccine InstituteRan2006 to 2013Enrolled69,329ConditionsDiarrhea, Cholera, Vibrio InfectionsArmsbivalent killed whole cell oral cholera vaccine, Placebo
3 · Its place in the literature

Who cites it

13 citing papers in PubMed, 2 syntheses or guidelines pooled it.

  1. Pooled it
  2. Oral killed cholera vaccines for preventing cholera.The Cochrane database of systematic reviews · 2024
    Pooled it
  3. Trial
  4. Article
  5. Article
  6. Designs for Vaccine Studies.Annual review of statistics and its application · 2025
    Article
  7. Article
  8. Article
  9. Estimating Waning of Vaccine Effectiveness: A Simulation Study.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2023
    Article
  10. Mathematical Modeling of Endemic Cholera Transmission.The Journal of infectious diseases · 2021
    Article
  11. Article
  12. Review
  13. Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

6 authors.

Youyi FongVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N., Seattle, 98109, WA, USA.
M Elizabeth HalloranVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N., Seattle, 98109, WA, USA.
Jin Kyung ParkEpidemiology Unit, International Vaccine Institute, Seoul, Republic of Korea.
Florian MarksEpidemiology Unit, International Vaccine Institute, Seoul, Republic of Korea.
John D Clemensicddr,b, Dhaka, Bangladesh.
Dennis L ChaoVaccine and Infectious Disease Division, Fred Hutchinson Cancer Research Center, 1100 Fairview Ave N., Seattle, 98109, WA, USA. dennisc@idmod.org.ORCID 0000-0002-8253-6321

Funding

Methods for Evaluating Vaccine EfficacyR37AI032042 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI HALLORAN, M ELIZABETH · 2010 to 2019
$5.1M
Statistical methods for HIV-1 immune correlates studiesR01AI122991 · NIAID · FRED HUTCHINSON CANCER RESEARCH CENTER · PI FONG, YOUYI · 2016 to 2020
$1.6M
FHCRC High-Performance Computing ClusterS10OD020069 · OD · FRED HUTCHINSON CANCER RESEARCH CENTER · PI KOOPERBERG, CHARLES L · 2015 to 2015
$600k
National Institute of Allergy and Infectious Diseases R01-AI122991National Institute of Allergy and Infectious Diseases R37-AI032042NIAID NIH HHS R01 AI122991NIAID NIH HHS R37 AI032042NIH HHS S10 OD020069
6 · The paper itself

Abstract

backgroundOral 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.

methodsTo 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.

resultsVaccine 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.

conclusionsThrough 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 registrationClinicalTrials.gov identifier NCT00289224.

Indexed as

Administration, OralAdolescentAdultChildChild, PreschoolCholeraCholera VaccinesDouble-Blind MethodFemaleFollow-Up StudiesHumansInfantMalePlacebo EffectProportional Hazards ModelsRisk FactorsCholera VaccinesCholeraCluster randomized trialRandomized control trialVaccination

Identifiers

PMID29463233
PMCPMC5819652

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.