Evidence map›Paper›PMID 40614747›Full record

Trial reportThe lancet. HIV2025

Safety and immunogenicity of investigational tuberculosis vaccine M72/AS01

Alemnew F Dagnew, Linda L Han, Kogieleum Naidoo, Lee Fairlie, James C Innes, Keren Middelkoop, Michele Tameris, Robert J Wilkinson, Jintanat Ananworanich, Daniel Bower and 5 more

Abstract readClinical Trial, Phase IIRandomized Controlled Trial
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The lancet. HIV, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 12 papers.

0numbers the graph read from it
0cells of the map it votes in
12citing 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

12 citing papers in PubMed.

  1. Article
  2. Article
  3. Preparing for Tuberculosis Vaccine M72/AS01Infectious diseases and therapy · 2026
    Article
  4. Review
  5. Article
  6. Article
  7. Article
  8. Review
  9. Review
  10. Review
  11. Review
  12. 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

15 authors.

Alemnew F DagnewGates Medical Research Institute, Clinical Development, Cambridge, MA, USA. Electronic address: alemnew.dagnew@gatesmri.org.
Linda L HanGates Medical Research Institute, Clinical Development, Cambridge, MA, USA.
Kogieleum NaidooCAPRISA-South African Medical Research Council (SAMRC) TB-HIV Pathogenesis and Treatment Research Unit, University of KwaZulu-Natal Nelson R Mandela School of Medicine, Durban, South Africa.
Lee FairlieWits RHI, Faculty of Health Sciences, University of the Witwatersrand, Johannesburg, South Africa.
James C InnesThe Aurum Institute, Clinical Research Division, Aurum Klerksdorp Clinical Research, Klerksdorp, South Africa.
Keren MiddelkoopDesmond Tutu HIV Center, Institute of Infectious Disease and Molecular Medicine, Department of Medicine, University of Cape Town, Cape Town, South Africa.
Michele TamerisSouth African Tuberculosis Vaccine Initiative (SATVI), Department of Pathology and Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Cape Town, South Africa.
Robert J WilkinsonWellcome Discovery Research Platforms in Infection, Center for Infectious Diseases Research in Africa, Institute of Infectious Disease and Molecular Medicine and Department of Medicine, University of Cape Town, Cape Town, South Africa; Francis Crick Institute, London, UK; Department of Infectious Diseases, Imperial College London, London, UK.
Jintanat AnanworanichGates Medical Research Institute, Clinical Development, Cambridge, MA, USA.
Daniel BowerGates Medical Research Institute, Clinical Development, Cambridge, MA, USA.
Lisa SchlehuberGates Medical Research Institute, Clinical Development, Cambridge, MA, USA.
Nicole FrahmGates Medical Research Institute, Clinical Development, Cambridge, MA, USA.
Amy CinarGates Medical Research Institute, Clinical Development, Cambridge, MA, USA.
Michael DunneGates Medical Research Institute, Clinical Development, Cambridge, MA, USA.
Alexander C SchmidtGates Medical Research Institute, Clinical Development, Cambridge, MA, USA.

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundM72/AS01

methodsIn this observer-blinded, randomised, controlled, phase 2 trial, participants aged 16-35 years with well controlled HIV were enrolled from urban, semi-urban, and semi-rural settings in South Africa, including sites with high tuberculosis and HIV prevalence, as well as agricultural and mining communities. Participants were randomly assigned (1:1), stratified by site and interferon-gamma release assay (IGRA) status, to receive two intramuscular doses of M72/AS01

findingsBetween Nov 17, 2020, and Aug 12, 2022, 402 eligible participants were assigned treatment, of whom 401 participants received at least one dose of M72/AS01

interpretationThe two-dose regimen of the M72/AS01

fundingGates Foundation and the Wellcome Trust.

Indexed as

HIV InfectionsImmunogenicity, VaccineTuberculosisTuberculosis VaccinesAdolescentAdultAntigens, BacterialFemaleHumansMaleMycobacterium tuberculosisSouth AfricaYoung AdultAntigens, BacterialTuberculosis Vaccines

Identifiers

PMID40614747
PMCPMC12310912

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.