Evidence map›Paper›PMID 40250461›Full record

Trial reportThe Lancet. Global health2025

Live-attenuated Mycobacterium tuberculosis vaccine, MTBVAC, in adults with or without M tuberculosis sensitisation: a single-centre, phase 1b-2a, double-blind, dose-escalation, randomised controlled trial.

Angelique Kany Kany Luabeya, Virginie Rozot, Claire Imbratta, Frances Ratangee, Justin Shenje, Michele Tameris, Simon C Mendelsohn, Hennie Geldenhuys, Michelle Fisher, Munyaradzi Musvosvi and 20 more

Registry-linked trialAbstract readRandomized Controlled TrialClinical Trial, Phase IClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in The Lancet. Global health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT02933281 (MTBVAC Phase 1b/2a Randomized, Double-blind, Active-controlled,Safety, Immunogenicity, and Dose-escalation Study in Adults With and Without Latent Tuberculosis Infection in South Africa), which is not on this map. Cited by 10 papers.

0numbers the graph read from it
0cells of the map it votes in
10citing 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.

NCT02933281 phase1 / phase2completednot on this map

MTBVAC Phase 1b/2a Randomized, Double-blind, Active-controlled,Safety, Immunogenicity, and Dose-escalation Study in Adults With and Without Latent Tuberculosis Infection in South Africa

TypeinterventionalSponsorInternational AIDS Vaccine InitiativeRan2018 to 2021Enrolled144ConditionsTuberculosisArmsMTBVAC, BCG
3 · Its place in the literature

Who cites it

10 citing papers in PubMed.

  1. Review
  2. Construction and characterization of novelInfection and immunity · 2026
    Article
  3. Review
  4. Vaccine development againstClinical and experimental vaccine research · 2026
    Review
  5. mBio · 2026
    Article
  6. Article
  7. Review
  8. bioRxiv : the preprint server for biology · 2025
    Article
  9. Review
  10. 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

30 authors.

Angelique Kany Kany LuabeyaSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Virginie RozotSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Claire ImbrattaSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Frances RatangeeSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Justin ShenjeSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Michele TamerisSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Simon C MendelsohnSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Hennie GeldenhuysSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Michelle FisherSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Munyaradzi MusvosviSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Carly YoungSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Humphrey MulengaSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Nicole BilekSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Simbarashe MabweSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Ingrid Murillo JelsbakBiofabri, Porriño (Pontevedra), Spain.
Esteban RodríguezBiofabri, Porriño (Pontevedra), Spain.
Eugenia PuentesBiofabri, Porriño (Pontevedra), Spain.
Juana DoceBiofabri, Porriño (Pontevedra), Spain.
Nacho AguiloDepartment of Microbiology Pediatrics, Radiology, and Public Health, Faculty of Medicine, University of Zaragoza, CIBERES, Instituto Salud Carlos III, Madrid, Spain.
Carlos MartinDepartment of Microbiology Pediatrics, Radiology, and Public Health, Faculty of Medicine, University of Zaragoza, CIBERES, Instituto Salud Carlos III, Madrid, Spain.
Cadwill PillayIAVI, New York, NY, USA; IAVI, Cape Town, South Africa.
Dereck TaitIAVI, New York, NY, USA; IAVI, Cape Town, South Africa.
Marisa RussellIAVI, New York, NY, USA; IAVI, Cape Town, South Africa.
Arrie Van Der MerveIAVI, New York, NY, USA; IAVI, Cape Town, South Africa.
Kathryn RutkowskiIAVI, New York, NY, USA; IAVI, Cape Town, South Africa.
Devin HuntIAVI, New York, NY, USA; IAVI, Cape Town, South Africa.
Ann GinsbergIAVI, New York, NY, USA; IAVI, Cape Town, South Africa; Bill & Melinda Gates Foundation, Seattle, WA, USA.
Thomas J ScribaSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa.
Mark HatherillSouth African Tuberculosis Vaccine Initiative, Institute of Infectious Disease and Molecular Medicine and Department of Pathology, University of Cape Town, Cape Town, South Africa. Electronic address: mark.hatherill@uct.ac.za.
A050 team

Funding

MTBVAC Phase 1b/2a Randomized, Double-blind, Active-controlled, Safety, Immunogenicity, and Dose-escalation Study in Adults with and without Latent Tuberculosis Infection in South AfricaU01AI131861 · NIAID · INTERNATIONAL AIDS VACCINE INITIATIVE · PI LAUFER, DAGNA · 2017 to 2019
$714k
NIAID NIH HHS U01 AI131861
6 · The paper itself

Abstract

backgroundAn effective adult vaccine is needed to control tuberculosis. We evaluated the safety and immunogenicity of a live-attenuated Mycobacterium tuberculosis vaccine (MTBVAC).

methodsThis single-centre, phase 1b-2a, double-blind, dose-escalation, randomised controlled trial (NCT02933281) enrolled South African adults previously vaccinated with BCG, who were HIV negative and aged 18-50 years, with or without M tuberculosis sensitisation assessed by QuantiFERON-tuberculosis Gold-Plus assay (QFT). Participants were recruited from the local community and randomly allocated (2:1) to receive MTBVAC (5 × 10

findingsBetween Jan 15, 2019, and Sept 7, 2020, 485 participants provided consent and were screened. 144 participants were enrolled and 143 (99%) were vaccinated. BCG was administrated to 47 (33%) of 143 and MTBVAC to 96 (67%) of 143. 12 participants with QFT-negative results and 12 with QFT-positive results were randomly allocated to receive each dose of MTBVAC and 24 participants with QFT-negative results and 24 with QFT-positive results were randomly allocated to receive BCG revaccination. Injection-site pain, discharge, erythema, and swelling increased with MTBVAC dose level. MTBVAC 5 × 10

interpretationMTBVAC at the 5 × 10

fundingCongressionally Directed Medical Research Programmes and US National Institutes of Health.

Indexed as

Mycobacterium tuberculosisTuberculosisTuberculosis VaccinesAdolescentAdultBCG VaccineDouble-Blind MethodFemaleHumansMaleMiddle AgedSouth AfricaVaccines, AttenuatedYoung AdultBCG VaccineMTBVAC vaccineTuberculosis VaccinesVaccines, Attenuated

Identifiers

PMID40250461
PMCPMC12780950

What OpenQuestion holds

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Registered trials

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.