Evidence map›Paper›PMID 36395746›Full record

Trial reportThe American journal of tropical medicine and hygiene2022

An Age-stratified, Randomized Immunogenicity Trial of Killed Oral Cholera Vaccine with Delayed Second Dose in Cameroon.

Jérôme Ateudjieu, David A Sack, Sonia Sonkeng Nafack, Shaoming Xiao, Ketina Hirma Tchio-Nighie, Herve Tchokomeni, Landry Beyala Bita'a, Paul Ntsekendio Nyibio, Etienne Guenou, Kedia Mayah Mondung and 6 more

Abstract readRandomized Controlled TrialEquivalence Trial
In one paragraph

Trial report in The American journal of tropical medicine and hygiene, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 3 papers.

0numbers the graph read from it
0cells of the map it votes in
3citing papers in PubMed
–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.

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

3 citing papers in PubMed.

  1. Article
  2. Article
  3. 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

16 authors.

Jérôme AteudjieuMA Sante, Yaoundé, Cameroon.
David A SackDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Sonia Sonkeng NafackMA Sante, Yaoundé, Cameroon.
Shaoming XiaoDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Ketina Hirma Tchio-NighieMA Sante, Yaoundé, Cameroon.
Herve TchokomeniMA Sante, Yaoundé, Cameroon.
Landry Beyala Bita'aMA Sante, Yaoundé, Cameroon.
Paul Ntsekendio NyibioMA Sante, Yaoundé, Cameroon.
Etienne GuenouMA Sante, Yaoundé, Cameroon.
Kedia Mayah MondungMA Sante, Yaoundé, Cameroon.
Frank Forex Kiadjieu DieumoMA Sante, Yaoundé, Cameroon.
Rosanne Minone NgomeDepartment of Bacteriology-Parasitology-Mycology Laboratory, Centre Pasteur of Cameroon (CPC), Yaoundé, Cameroon.
Kelsey N MurtDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Malathi RamDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Mohammad AliDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.
Amanda K DebesDepartment of International Health, Johns Hopkins Bloomberg School of Public Health, Baltimore, Maryland.

Funding

Epidemiology and Ecology of Cholera in AfricaR01AI123422 · NIAID · JOHNS HOPKINS UNIVERSITY · PI Amanda Kay Debes, DAVID A SACK · 2017 to 2026
$6.6M
NIAID NIH HHS R01 AI123422
6 · The paper itself

Abstract

The recommended schedule for killed oral cholera vaccine (OCV) is two doses, 2 weeks apart. However, during vaccine campaigns, the second round is often delayed by several months. Because more information is needed to document antibody responses when the second dose is delayed, we conducted an open-label, phase 2, noninferiority clinical trial of OCV. One hundred eighty-six participants were randomized into three dose-interval groups (DIGs) to receive the second dose 2 weeks, 6 months, or 11.5 months after the first dose. The DIGs were stratified into three age strata: 1 to 4, 5 to 14, and > 14 years. Inaba and Ogawa vibriocidal titers were assessed before and after vaccination. The primary analysis was geometric mean titer (GMT) 2 weeks after the second dose. Data for primary analysis was available from 147 participants (54, 44, and 49 participants from the three DIGs respectively). Relative to the 2-week interval, groups receiving a delayed second dose had significantly higher GMTs after the second dose. Two weeks after the second dose, Inaba GMTs were 55.1 190.3, and 289.8 and Ogawa GMTs were 70.4, 134.5, and 302.4 for the three DIGs respectively. The elevated titers were brief, returning to lower levels within 3 months. We conclude that when the second dose of killed oral cholera vaccine was given after 6 or 11.5 months, vibriocidal titers were higher than when given after the standard period of 2 weeks. This provides reassurance that a delayed second dose does not compromise, but rather enhances, the serological response to the vaccine.

Indexed as

CholeraCholera VaccinesAdministration, OralAdolescentAntibodies, BacterialCameroonHumansVaccines, InactivatedAntibodies, BacterialCholera VaccinesVaccines, Inactivated

Identifiers

PMID36395746
PMCPMC9709001

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.