Evidence map›Paper›PMID 42746611›Full record

ArticleIJTLD open2026

Inclusion of pregnant and lactating women in TB treatment and vaccine trials.

S-A Meehan, A C Hesseling, L Viljoen, L M Cranmer, S Verkuijl, K Viney, M Maktabi, M Isaacs, Y Hirsch-Moverman

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Article in IJTLD open, 2026. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.

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

0 citing papers in PubMed.

No citing paper in PubMed yet.

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

9 authors.

S-A MeehanDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa.
A C HesselingDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa.
L ViljoenDesmond Tutu TB Centre, Department of Paediatrics and Child Health, Faculty of Medicine and Health Sciences, Stellenbosch University, South Africa.
L M CranmerEmory University, Atlanta, GA, USA.
S VerkuijlDepartment of HIV, Tuberculosis, Hepatitis and Sexually Transmitted Infections, World Health Organization, Geneva, Switzerland.
K VineyDepartment of HIV, Tuberculosis, Hepatitis and Sexually Transmitted Infections, World Health Organization, Geneva, Switzerland.
M MaktabiDepartment of Epidemiology at Mailman School of Public Health, Columbia University, New York, NY, USA.
M IsaacsDepartment of Epidemiology at Mailman School of Public Health, Columbia University, New York, NY, USA.
Y Hirsch-MovermanDepartment of Epidemiology at Mailman School of Public Health, Columbia University, New York, NY, USA.

Funding

The role of antibodies in infant TB preventionK23AI143479 · NIAID · EMORY UNIVERSITY · PI CRANMER, LISA M · 2019 to 2023
$950k
NIAID NIH HHS K23 AI143479
6 · The paper itself

Abstract

backgroundHistorically, pregnant and lactating women (PLW) have been excluded from clinical trials for TB, thereby denying them access to novel treatment and prevention regimens. We aimed to develop an inventory of TB therapeutic and vaccine trials and determine the barriers and facilitators to the inclusion of PLW in TB clinical trials.

methodsUsing a mixed-methods approach, we conducted: a review of recent, current, and planned trials' inclusion and exclusion practices, and in-depth interviews with trialists and sponsors.

resultsOf 40 TB therapeutic trials, 7/40 (18%) included PLW; 3/40 (8%) excluded PLW at enrolment but allowed women to remain on study treatment if they became pregnant. None of 12 vaccine trials included PLW but 6/12 (50%) included PLW in safety and/or immunogenicity assessments during study follow-up. Eighteen participants completed in-depth interviews. We identified four broad themes: shifting the narrative, differentiated risks, perceived concerns of PLW, and strategies for inclusion.

conclusionsWith limited inclusion of PLW in TB therapeutic trials and no inclusion in vaccine trials at the time of enrolment, there was consensus that clear guidance is required for trialists, funders, and sponsors on strategies for inclusion of PLW, thus ensuring equitable access to novel TB prevention and treatment regimens.

Indexed as

pregnancypreventiontreatment regimentuberculosisvaccines

Identifiers

PMID42746611
PMCPMC13577204

What OpenQuestion holds

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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.