Evidence map›Paper›PMID 38341355›Full record

ArticleBiologicals : journal of the International Association of Biological Standardization2024

Fourth Controlled Human Infection Model (CHIM) meeting, CHIM regulatory issues, May 24, 2023.

Marco Cavaleri, David Kaslow, Eric Boateng, Wilbur H Chen, Christopher Chiu, Robert K M Choy, Rodrigo Correa-Oliveira, Anna Durbin, Moses Egesa, Malick Gibani and 13 more

Abstract read
In one paragraph

Article in Biologicals : journal of the International Association of Biological Standardization, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 9 papers.

0numbers the graph read from it
0cells of the map it votes in
9citing 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

9 citing papers in PubMed.

  1. Review
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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

23 authors.

Marco CavaleriEuropean Medicines Agency, Netherlands. Electronic address: marco.cavaleri@ema.europa.eu.
David KaslowUS Food & Drugs Administration, USA. Electronic address: david.kaslow@fda.hhs.gov.
Eric BoatengFood and Drugs Authority, Ghana. Electronic address: gus4tee@gmail.com.
Wilbur H ChenCenter for Vaccine Development, University of Maryland School of Medicine, USA. Electronic address: wilbur.chen@som.umaryland.edu.
Christopher ChiuImperial College London, UK. Electronic address: c.chiu@imperial.ac.uk.
Robert K M ChoyPATH Center for Vaccine Innovation and Access, Seattle, WA, USA. Electronic address: rchoy@path.org.
Rodrigo Correa-OliveiraFundação Oswaldo Cruz (Fiocruz), Brazil.
Anna DurbinJohns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: adurbin1@jhu.edu.
Moses EgesaMRC/UVRI and LSHTM Uganda Research Unit, Uganda; London School of Hygiene and Tropical Medicine, UK. Electronic address: Moses.Egesa@mrcuganda.org.
Malick GibaniImperial College London, UK. Electronic address: m.gibani@imperial.ac.uk.
Melissa KapuluKEMRI-Wellcome Trust Research Programme, Kenya. Electronic address: mkapulu@kemri-wellcome.org.
Melba KatindiKatindi & Company, Kenya. Electronic address: mkatindi@katindilawyers.co.ke.
Ally OlotuIfakara Health Institute, Tanzania. Electronic address: aolotu@ihi.or.tz.
Pongphaya PongsuwanMahidol Oxford Tropical Medicine Research Unit, Bangkok, Thailand.
Michelo SimuyandiCentre for Infectious Disease Research, Zambia. Electronic address: Michelo.Simuyandi@cidrz.org.
Bruno SpederHVIVO plc, UK. Electronic address: b.speder@hvivo.com.
Kawsar R TalaatJohns Hopkins Bloomberg School of Public Health, Baltimore, USA. Electronic address: ktalaat@jhu.edu.
Charlie WellerWellcome Trust, London, UK. Electronic address: C.Weller@wellcome.org.
Bridget WillsOxford University Clinical Research Unit, Ho Chi Minh City, Viet Nam. Electronic address: bwills@oucru.org.
Marc BaayP95 Epidemiology & Pharmacovigilance, Leuven, Belgium. Electronic address: marc.baay@p-95.com.
Shobana BalasingamWellcome Trust, London, UK. Electronic address: shobana.balasingam@wellcome.org.
Ole F OlesenEuropean Vaccine Initiative, Heidelberg, Germany. Electronic address: ole.olesen@euvaccine.eu.
Pieter NeelsIABS-EU, Lyon, France. Electronic address: pieter.neels@vaccine-advice.be.

Funding

Medical Research Council MC_UU_00027/5Wellcome Trust 218528
6 · The paper itself

Abstract

Many aspects of Controlled Human Infection Models (CHIMs, also known as human challenge studies and human infection studies) have been discussed extensively, including Good Manufacturing Practice (GMP) production of the challenge agent, CHIM ethics, environmental safety in CHIM, recruitment, community engagement, advertising and incentives, pre-existing immunity, and clinical, immunological, and microbiological endpoints. The fourth CHIM meeting focused on regulation of CHIM studies, bringing together scientists and regulators from high-, middle-, and low-income countries, to discuss barriers and hurdles in CHIM regulation. Valuable initiatives for regulation of CHIMs have already been undertaken but further capacity building remains essential. The Wellcome Considerations document is a good starting point for further discussions.

Indexed as

Deliberate infectionHuman challengeInfectious diseasesLow- and middle-income countriesVaccine

Identifiers

PMID38341355
PMCPMC7616643

What OpenQuestion holds

Textmetadata
LicenceCC BY-NC-ND
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.