Evidence map›Paper›PMID 26023778›Full record

Trial reportPLoS neglected tropical diseases2015

An Open Label Non-inferiority Trial Assessing Vibriocidal Response of a Killed Bivalent Oral Cholera Vaccine Regimen following a Five Year Interval in Kolkata, India.

Suman Kanungo, Sachin N Desai, Jayanta Saha, Ranjan Kumar Nandy, Anuradha Sinha, Deok Ryun Kim, Barnali Bannerjee, Byomkesh Manna, Jae Seung Yang, Mohammad Ali and 2 more

Open access · goldAbstract readClinical Trial, Phase IIIRandomized Controlled Trial
In one paragraph

Trial report in PLoS neglected tropical diseases, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers, 2 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
12citing papers in PubMed, 2 pooled it
1.7field-weighted citation impact, top 19% of its field
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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

12 citing papers in PubMed, 2 syntheses or guidelines pooled it, 15 citations in OpenAlex.

  1. Oral killed cholera vaccines for preventing cholera.The Cochrane database of systematic reviews · 2024
    Pooled it
  2. Immunogenicity and Protection From a Single Dose of Internationally Available Killed Oral Cholera Vaccine: A Systematic Review and Metaanalysis.Clinical infectious diseases : an official publication of the Infectious Diseases Society of America · 2018
    Pooled it
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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

12 authors at 2 institutions in 3 countries.

Suman KanungoNational Institute of Cholera and Enteric Diseases, Kolkata, India.
Sachin N DesaiInternational Vaccine Institute, Seoul, Republic of Korea.
Jayanta SahaNational Institute of Cholera and Enteric Diseases, Kolkata, India.
Ranjan Kumar NandyNational Institute of Cholera and Enteric Diseases, Kolkata, India.
Anuradha SinhaNational Institute of Cholera and Enteric Diseases, Kolkata, India.
Deok Ryun KimInternational Vaccine Institute, Seoul, Republic of Korea.
Barnali BannerjeeInternational Vaccine Institute, Seoul, Republic of Korea.
Byomkesh MannaNational Institute of Cholera and Enteric Diseases, Kolkata, India.
Jae Seung YangInternational Vaccine Institute, Seoul, Republic of Korea.
Mohammad AliNational Institute of Cholera and Enteric Diseases, Kolkata, India; Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland, United States of America.
Dipika SurNational Institute of Cholera and Enteric Diseases, Kolkata, India; PATH India Office, New Delhi, India.
Thomas F WierzbaInternational Vaccine Institute, Seoul, Republic of Korea.
National Institute of Cholera and Enteric Diseases · INInternational Vaccine Institute · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundThe bivalent killed oral cholera vaccine (OCV) provides 65% cumulative protection over five years. It remains unknown whether a boosting regimen can maintain protection in previously immunized populations. This study examines the immunogenicity and safety of an OCV regimen given five years following initial dosing. METHODOLOGY/PRINCIPAL

findingsAn open label controlled trial was conducted in 426 healthy Indian participants previously enrolled in a large efficacy trial. To assess whether an OCV regimen given after five years can elicit an antibody response equal to that of a primary series, we compared vibriocidal antibody titers in previously immunized participants receiving a two dose booster regimen to participants receiving a primary two dose immunization series. Among participants receiving a two dose primary series of OCV (n = 186), 69% (95% CI 62%-76%) seroconverted. In the intervention arm (n = 184), 66% (95% CI 59%-73%) seroconverted following a two dose boosting schedule given five years following the initial series. Following a single boosting dose, 71% (95% CI 64%-77%) seroconverted. Children demonstrated 79% (95% CI 69%-86%) and 82% (95% CI 73%-88%) seroconversion after primary and boosting regimens, respectively. CONCLUSIONS/SIGNIFICANCE: Administration of an OCV boosting regimen elicits an immune response similar to those receiving a primary series in endemic areas. Though a single boosting dose induces a strong immune response, further investigations are needed to measure if these findings translate to clinical protection.

Indexed as

VaccinationAdministration, OralAdolescentAdultAntibodies, BacterialChildCholeraCholera VaccinesCohort StudiesDouble-Blind MethodFemaleHumansImmunization, SecondaryIndiaMaleVaccines, InactivatedAntibodies, BacterialCholera VaccinesVaccines, Inactivated

Identifiers

PMID26023778
PMCPMC4449043
OpenAlexW601581515

What OpenQuestion holds

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LicenceCC BY
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Registered trials

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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.