MTBVAC
/ Zendal Group
- LARVOL DELTA
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December 03, 2025
Status of Tuberculosis Vaccines Development in Clinical Trials
(PubMed, Jugan Geongang Gwa Jilbyeong)
- "The recombinant protein-based M72/AS01E vaccine has been mentioned as a potential vaccine, and is currently recruiting subjects for a Phase 3 clinical trial. In addition, recombinant protein-based GemTBvac and whole cell-based MIP, MTBVAC, and VPM1002 are in Phase 3 clinical trials. While several platform-based TB vaccine candidates are in clinical trials; however, the antigens contained in these candidates are often redundant and limited. To diversify the TB vaccine clinical pipeline, it is necessary to continue research to identify new antigens, the development of preclinical animal models for efficacy evaluation, and the identification of valid endpoints through the analysis of clinical trial results are necessary."
Journal • Review • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis
November 13, 2025
Overcoming Treatment Challenges in HIV-Associated Mycobacterial Diseases: New Therapeutic Frontiers.
(PubMed, Int J Mol Sci)
- "Beyond established regimens, we highlight host-directed strategies such as metformin, glutathione augmentation, mTOR modulation, and vitamin D; immunotherapies including interferon-γ, GM-CSF, and IL-7; and therapeutic vaccines (M72/AS01E, MTBVAC, VPM1002) as promising adjuncts. Distinct from guideline-focused overviews, this review emphasizes non-tuberculous mycobacterial disease (NTM, including MAC) and leprosy in PLWH and synthesizes host-directed and adjunctive strategies with their translational prospects, including ART compatibility and IRIS. By integrating TB, NTM, and leprosy across the HIV care continuum, we highlight opportunities not treated in detail elsewhere-particularly HDT-enabled approaches and implementation considerations in PLWH."
Journal • Review • Human Immunodeficiency Virus • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CSF2 • IFNG • IL7
September 20, 2025
A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in IGRA Positive Adolescents and Adults Living in a TB Endemic Region.
(clinicaltrials.gov)
- P2 | N=4300 | Recruiting | Sponsor: International AIDS Vaccine Initiative | Not yet recruiting ➔ Recruiting
Enrollment open • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis
May 30, 2025
MTBVACph2: Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)
(clinicaltrials.gov)
- P2 | N=164 | Recruiting | Sponsor: Bharat Biotech International Limited
New P2 trial • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis
May 22, 2025
BBV169/2023: Tuberculosis Vaccine in Healthy Indian Adults
(clinicaltrials.gov)
- P1 | N=30 | Completed | Sponsor: Bharat Biotech International Limited | Active, not recruiting ➔ Completed
Trial completion • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis
April 28, 2025
MTBVAC-03: Dose-Defining Safety and Immunogenicity Study of MTBVAC in South African Neonates
(clinicaltrials.gov)
- P2 | N=99 | Completed | Sponsor: Biofabri, S.L | Phase classification: P2a ➔ P2
Phase classification • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis
April 19, 2025
Diagnostic dilemmas and strain diversity in the MTBVAC phase 1b-2a trial in adults.
(PubMed, Lancet Glob Health)
- No abstract available
Journal • P1/2 data
April 19, 2025
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.
(PubMed, Lancet Glob Health)
- P1b/2a | "MTBVAC at the 5 × 105 dose showed similar safety and reactogenicity and greater immunogenicity when compared to BCG. These results suggest that the 5 × 105 dose of MTBVAC could be selected for a subsequent efficacy evaluation."
Journal • P1/2 data • Dermatology • Human Immunodeficiency Virus • Infectious Disease • Pain • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4
March 29, 2025
Cytolytic γδ T-cells and IFNγ-producing CD4-lymphocytes characterise the early response to MTBVAC tuberculosis vaccine.
(PubMed, NPJ Vaccines)
- "Importantly, MTBVAC-activated γδ T-cells had a unique cytotoxic CD16+GZMB+ phenotype, reminiscent of effector cells found in Mtb positive individuals controlling infection. IFN-γ and TNF-α were released in cultures, while IL-17A/F were almost undetectable."
Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • GZMB • IFNG • IL17A • TNFA
March 19, 2025
Safety, reactogenicity, and immunogenicity of MTBVAC in infants: a phase 2a randomised, double-blind, dose-defining trial in a TB endemic setting.
(PubMed, EBioMedicine)
- "MTBVAC appeared safe, well-tolerated, and immunogenic at doses between 2.5 × 104 and 2.5 × 106 CFU in South African infants. The 2.5 × 105 CFU MTBVAC dose, being less reactogenic and more immunogenic than BCG, was selected for a multi-centre, phase 3 trial."
Journal • P2a data • CNS Disorders • Dermatology • Human Immunodeficiency Virus • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • IFNG
February 12, 2025
MTBVACN3: Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
(clinicaltrials.gov)
- P3 | N=7120 | Recruiting | Sponsor: Biofabri, S.L | Trial completion date: Sep 2029 ➔ Feb 2029 | Trial primary completion date: Jun 2028 ➔ Feb 2029
Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8 • IFNG • IL17A • IL2 • IL22
November 21, 2024
MTBVAC induces superior antibody titers and IgG avidity compared to BCG vaccination in non-human primates.
(PubMed, NPJ Vaccines)
- "MTBVAC vaccination induced higher titers of IgG, IgM and IgA, and higher avidity IgG compared with BCG vaccination. IgG avidity correlated with protection following M.tb challenge in the same animals, validating the association previously reported between this measure and protection in the context of intravenous BCG vaccination, suggesting that IgG avidity may represent a relevant marker or correlate of protection from TB."
Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis
October 25, 2024
Clinical Development of MTBVAC, a live attenuated MTb vaccine
(WVCE 2024)
- No abstract available
Clinical
August 23, 2024
Correlation between systemic allergen desensitisation and long-term asthma protection in mice following intravenous administration of the live tuberculosis vaccine MTBVAC.
(PubMed, EBioMedicine)
- "Altogether, our results suggest that intravenous MTBVAC could be a plausible allergen desensitising approach for treatment of asthma, and could provide long-term protection against allergen exposure."
Journal • Preclinical • Asthma • Eosinophilia • Immunology • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • IL4 • IL5
August 09, 2024
HVTN605A5421: Evaluating the Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living With and Without HIV in South Africa
(clinicaltrials.gov)
- P2 | N=276 | Recruiting | Sponsor: HIV Vaccine Trials Network | Trial completion date: Nov 2024 ➔ Feb 2026 | Trial primary completion date: Nov 2024 ➔ Feb 2026
Trial completion date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8
June 03, 2024
BBV169/2023: Tuberculosis Vaccine in Healthy Indian Adults
(clinicaltrials.gov)
- P1 | N=30 | Active, not recruiting | Sponsor: Bharat Biotech International Limited
New P1 trial • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis
May 27, 2024
Low-dose M.tb infection but not BCG or MTBVAC vaccination enhances heterologous antibody titres in non-human primates.
(PubMed, Front Immunol)
- "Our findings suggest that it is unlikely that heterologous antibodies contribute to the non-specific effects of these vaccines. The apparent dysregulation of B cell responses associated with TB disease warrants further investigation, with potential implications for risk of B cell cancers and novel therapeutic strategies."
Journal • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Infectious Disease • Novel Coronavirus Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Respiratory Syncytial Virus Infections • Tetanus • Tuberculosis
April 02, 2024
SAFETY, REACTOGENICITY AND IMMUNOGENICITY OF MTBVAC IN NEWBORNS IN A TB ENDEMIC AREA: A PHASE 2A RANDOMIZED, DOUBLE-BLIND, DOSE-DEFINING TRIAL
(ESPID 2024)
- "Conclusions/Learning Points MTBVAC appeared safe, well tolerated and immunogenic at doses between 2.5×10⁴ CFU and 2.5×106 CFU in South African newborns. The 2.5×105 CFU MTBVAC dose was selected for the ongoing phase 3 trial in a high TB prevalence setting"
Clinical • P2a data • CNS Disorders • Dermatology • Human Immunodeficiency Virus • Infectious Disease • Pneumonia • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4
May 10, 2024
Susceptibility testing of the live attenuated tuberculosis vaccine BCG and the vaccine candidate MTBVAC to currently WHO-recommended anti-tuberculosis drugs by the EUCAST method.
(PubMed, Clin Microbiol Infect)
- No abstract available
Journal • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis
April 02, 2024
Editorial: Forty Years of Waiting for Prevention and Cure of HIV Infection - Ongoing Challenges and Hopes for Vaccine Development and Overcoming Antiretroviral Drug Resistance.
(PubMed, Med Sci Monit)
- "MTBVAC is the first live attenuated vaccine to prevent Mycobacterium tuberculosis infection, with phase 2a safety and efficacy clinical trial data expected at the end of 2024. This editorial aims to summarize the current challenges and hopes for developing vaccines to prevent HIV infection and approaches to overcome antiretroviral drug resistance as a cure for HIV/AIDS."
Journal • Human Immunodeficiency Virus • Infectious Disease • Oncology • Pulmonary Disease • Respiratory Diseases • Tuberculosis
February 22, 2024
A Study to Evaluate the Efficacy, Safety and Immunogenicity of MTBVAC in IGRA Positive Adolescents and Adults Living in a TB Endemic Region.
(clinicaltrials.gov)
- P2 | N=4300 | Not yet recruiting | Sponsor: International AIDS Vaccine Initiative
New P2 trial • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis
February 01, 2024
HVTN605A5421: Evaluating the Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living With and Without HIV in South Africa
(clinicaltrials.gov)
- P2 | N=276 | Recruiting | Sponsor: HIV Vaccine Trials Network | Not yet recruiting ➔ Recruiting
Enrollment open • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8
October 02, 2023
MTBVACN3: Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa
(clinicaltrials.gov)
- P3 | N=6960 | Recruiting | Sponsor: Biofabri, S.L | Trial primary completion date: Jun 2027 ➔ Jun 2028
Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8
September 21, 2023
HVTN605A5421: Evaluating the Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living With and Without HIV in South Africa
(clinicaltrials.gov)
- P2a | N=276 | Not yet recruiting | Sponsor: HIV Vaccine Trials Network | Initiation date: Aug 2023 ➔ Jan 2024
Trial initiation date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8
July 17, 2023
HVTN605A5421: Evaluating the Safety and Immunogenicity of MTBVAC in Adolescents and Adults Living With and Without HIV in South Africa
(clinicaltrials.gov)
- P2a | N=276 | Not yet recruiting | Sponsor: HIV Vaccine Trials Network
New P2a trial • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8
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