Evidence map›Paper›PMID 37537677›Full record

Trial reportTrials2023

An observer-blinded, cluster randomised trial of a typhoid conjugate vaccine in an urban South Indian cohort.

Nikhil Sahai, Dilesh Kumar Arunachalam, Tim Morris, Andrew Copas, Prasanna Samuel, Venkata Raghava Mohan, Vinod Abraham, Joshua Anish Selwyn, Praveen Kumar, Winsley Rose and 3 more

Open access · goldAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Trials, 2023. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 5 papers.

0numbers the graph read from it
0cells of the map it votes in
5citing papers in PubMed
1.0field-weighted citation impact, top 23% 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

5 citing papers in PubMed, 5 citations in OpenAlex.

  1. Article
  2. Article
  3. Article
  4. Review
  5. Review
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

13 authors at 2 institutions in 2 countries.

Nikhil Sahai *Wellcome Trust Research Laboratory, Department of G.I. Sciences, Christian Medical College Vellore, Vellore, India.
Dilesh Kumar Arunachalam *Wellcome Trust Research Laboratory, Department of G.I. Sciences, Christian Medical College Vellore, Vellore, India.
Tim MorrisMRC Clinical Trials Unit, University College London, London, UK.
Andrew CopasMRC Clinical Trials Unit, University College London, London, UK.
Prasanna SamuelDepartment of Biostatistics, Christian Medical College Vellore, Vellore, India.
Venkata Raghava MohanDepartment of Community Health, Christian Medical College Vellore, Vellore, India.
Vinod AbrahamDepartment of Community Health, Christian Medical College Vellore, Vellore, India.
Joshua Anish SelwynDepartment of Community Health, Christian Medical College Vellore, Vellore, India.
Praveen KumarDepartment of Community Health, Christian Medical College Vellore, Vellore, India.
Winsley RoseDepartment of Paediatrics, Christian Medical College Vellore, Vellore, India.
Veeraraghavan BalajiDepartment of Clinical Microbiology, Christian Medical College Vellore, Vellore, India.
Gagandeep Kang *Wellcome Trust Research Laboratory, Department of G.I. Sciences, Christian Medical College Vellore, Vellore, India.
Jacob John *Department of Community Health, Christian Medical College Vellore, Vellore, India. jacob@cmcsph.org.ORCID http://orcid.org/0000-0003-3654-5099
Christian Medical College, Vellore · INMRC Clinical Trials Unit at UCL · GB

Funding

Bill & Melinda Gates Foundation INV-036437Medical Research Council MC_UU_00004/07Medical Research Council MC_UU_00004/09
6 · The paper itself

Abstract

backgroundTyphoid fever causes nearly 110,000 deaths among 9.24 million cases globally and disproportionately affects developing countries. As a control measure in such regions, typhoid conjugate vaccines (TCVs) are recommended by the World Health Organization (WHO). We present here the protocol of a cluster randomised vaccine trial to assess the impact of introducing TyphiBEV® vaccine to those between 1 and 30 years of age in a high-burden setting.

methodsThe primary objective is to determine the relative and absolute rate reduction of symptomatic, blood-culture-confirmed S. Typhi infection among participants vaccinated with TyphiBEV® in vaccine clusters compared with the unvaccinated participants in non-vaccine clusters. The study population is residents of 30 wards of Vellore (a South Indian city) with participants between the ages of 1 and 30 years who provide informed consent. The wards will be divided into 60 contiguous clusters and 30 will be randomly selected for its participants to receive TyphiBEV® at the start of the study. No placebo/control is planned for the non-intervention clusters, which will receive the vaccine at the end of the trial. Participants will not be blinded to their intervention. Episodes of typhoid fever among participants will be captured via stimulated, passive fever surveillance in the area for 2 years after vaccination, which will include the most utilised healthcare facilities. Observers blinded to the participants' intervention statuses will record illness details. Relative and absolute rate reductions will be calculated at the end of this surveillance and used to estimate vaccine effectiveness. DISCUSSION: The results from our trial will allow countries to make better-informed decisions regarding the TCV that they will roll-out and may improve the global supplies and affordability of the vaccines.

trial registrationClinical Trials Registry of India (CTRI) CTRI/2022/03/041314. Prospectively registered on 23 March 2022 ( https://ctri.nic.in/Clinicaltrials/pmaindet2.php?trialid=62548&EncHid=&userName=vellore%20typhoid ). CTRI collects the full WHO Trial Registration Data Set.

Indexed as

Typhoid FeverTyphoid-Paratyphoid VaccinesAdolescentAdultChildChild, PreschoolHumansIndiaInfantVaccinationVaccines, ConjugateYoung AdultTyphoid-Paratyphoid VaccinesVaccines, ConjugateClinical trialCluster randomisedIndiaTCVTyphoidTyphoid conjugate vaccineVaccine

Identifiers

PMID37537677
PMCPMC10399005
OpenAlexW4385551317

What OpenQuestion holds

Textmetadata
LicenceCC BY
Read underepoch 390

Registered trials

None linked

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.