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MTBVAC

Phase 3Biologic

BBharat Biotech International Limited

MTBVAC is one of 80 biologic programs targeting Tuberculosis. It is currently in Phase 3.

2

Indications

8

Total Trials

4

Active Trials

79

Competitors

Pipeline

Status by Indication[3][1]

Indication

TuberculosisCompleted

ImmunogenicityRecruiting

TuberculosisPhase 2

Completed

ImmunogenicityPhase 3

Recruiting

Competition

Competitive Landscape

87 competitors in Immunogenicity

#DrugCompanyPhaseTrials

Perjeta

Rabies Vaccine

Prolia

OOrganon and Co

HPV Vaccine

SShanghai Zerun Biotechnology Co.,Ltd

Gardasil-9

BBeijing Health Guard Biotechnology, Inc

Rsvpref

Bexsero

Gardasil

PCV21

Opfolda

Johnson & Johnson

Ranked by pipeline maturity and clinical activity. Current drug highlighted in teal.

Timeline

Expected Milestones

Q4 2027

Phase 2Recruiting

HIV I Infection

NCT05947890

Q4 2028

Phase 2Active, not recruiting

Tuberculosis (TB)

NCT06272812

Q1 2029

Phase 3Recruiting

Immunogenicity

NCT04975178

Clinical

Trials by Indication[1]

Immunogenicity4 trials

Dose-Defining Safety and Immunogenicity Study of MTBVAC in South African Neonates

Completed·BBiofabri, S.L·Phase 2·NCT03536117·99 enrolled

Dose-escalation Safety and Immunogenicity Study to Compare MTBVAC to BCG in Newborns With a Safety Arm in Adults

Completed·BBiofabri, S.L·Phase 1/2·NCT02729571·54 enrolled

Dose-Escalation Study to Evaluate the Safety and Immunogenicity of MTBVAC Vaccine in Comparison With BCG Vaccine.

Completed·BBiofabri, S.L·Phase 1·NCT02013245·36 enrolled

Show 1 more trial

Efficacy, Safety and Immunogenicity Evaluation of MTBVAC in Newborns in Sub-Saharan Africa

Recruiting·BBiofabri, S.L·Phase 3·NCT04975178·7,120 enrolled

Tuberculosis2 trials

MTBVAC Study in Adults With and Without Latent Tuberculosis Infection in South Africa

Completed·IInternational AIDS Vaccine Initiative·Phase 1/2·NCT02933281·144 enrolled

Safety and Immunogenicity of a Mycobacterium Tuberculosis Vaccine MTBVAC in Healthy Indian Adults and Adolescents (BBV169/2024)

Recruiting·BBharat Biotech International Limited·Phase 2·NCT06997367·164 enrolled

HIV I Infection1 trial

A Phase 2a Clinical Trial to Evaluate the Safety and Immunogenicity of MTBVAC

Recruiting·HHIV Vaccine Trials Network·Phase 2·NCT05947890·276 enrolled

Tuberculosis (TB)1 trial

A Phase 2b, Double-blind, Randomized, Placebo-controlled Study to Evaluate the Efficacy, Safety and Immunogenicity of a Candidate Tuberculosis (TB) Vaccine, MTBVAC, Against TB Disease in Adolescents and Adults Aged 14-45 Years, Living in a TB Endemic Region.

Active, not recruiting·IInternational AIDS Vaccine Initiative·Phase 2·NCT06272812·5,531 enrolled

Sources

References

[1]
ClinicalTrials.gov — 8 trial records for MTBVAC. U.S. National Library of Medicine, National Institutes of Health.
[2]
ChEMBL — MTBVAC compound record. European Bioinformatics Institute (EMBL-EBI).
[3]
Open Targets Platform — Drug–disease associations for MTBVAC. EMBL-EBI & Wellcome Sanger Institute.
[4]
SEC EDGAR — Bharat Biotech International Limited company filings. U.S. Securities and Exchange Commission.

Details

Drug Info

Quick Facts

Modality: Biologic[2]
Highest Phase: Phase 3[1]
Company: BBharat Biotech International Limited

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