VPM1002

Phase of Development

Phase 3

Vaccine Platform

Mycobacterial – Live Attenuated

Candidate Overview

VPM1002 is a recombinant, urease C-deficient, listeriolysin expressing BCG vaccine strain and was generated in order to induce a broader immune response against mycobacterial antigens.

Sponsor / Lead Developer: Serum Institute of India Private Limited

Development partner(s): Vakzine Projekt Management GmbH

Clinical Trial Status: No Active Trials

Primary Indication: Prevention of Mtb infection or sustained infection

Other Indication(s): Prevention of TB disease and Prevention of TB recurrence

Target Population(s): Adolescents, Adults, Children, Elderly, Infants, and People cured of active TB

Clinical Trials

COMPLETED TRIALS
Registry NumberNCT03152903 / CTRI/2017/03/008266/
Clinical Trial PhasePhase 2/3
Clinical Trial SponsorSerum Institute of India Pvt. Ltd.
Primary endpoint(s) for this clinical trialPrevention of TB recurrence
Target population(s) for clinical trialAdults
People cured of active TB
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Registry NumberCTRI/2019/01/017026
Clinical Trial PhasePhase 3
Clinical Trial SponsorIndian Council of Medical Research
Primary endpoint(s) for this clinical trialPrevention of TB disease
Target population(s) for clinical trialAdults
Adolescents
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Registry NumberNCT04351685
Clinical Trial PhasePhase 3
Clinical Trial SponsorSerum Institute of India Pvt. Ltd.
Primary endpoint(s) for this clinical trialPrevention of Mtb infection or sustained infection
Target population(s) for clinical trialInfants
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Registry NumberNCT02391415
Clinical Trial PhasePhase 2b
Clinical Trial SponsorSerum Institute of India Pvt. Ltd.
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialInfants
Results/PublicationSafety and immunogenicity of VPM1002 versus BCG in South African newborn babies: a randomised, phase 2 non-inferiority double-blind controlled trial (Lancet Infect. Dis., 2022)
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Registry NumberNCT01479972
Clinical Trial PhasePhase 2a
Clinical Trial SponsorVakzine Projekt Managment GmbH
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialInfants
Results/PublicationSafety and Immunogenicity of the Recombinant Mycobacterium bovis BCG Vaccine VPM1002 in HIV-Unexposed Newborn Infants in South Africa
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Registry NumberNCT01113281
Clinical Trial PhasePhase 1
Clinical Trial SponsorVakzine Projekt Managment GmbH
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults
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Registry NumberNCT00749034
Clinical Trial PhasePhase 1
Clinical Trial SponsorVakzine Projekt Managment GmbH
Primary endpoint(s) for this clinical trialSafety
Target population(s) for clinical trialAdults