VPM1002
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: 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
ACTIVE TRIALS |
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| Registry Number | NCT03152903 / CTRI/2017/03/008266/ |
| Clinical Trial Phase | Phase 2/3 |
| Clinical Trial Sponsor | Serum Institute of India Pvt. Ltd. |
| Primary endpoint(s) for this clinical trial | Prevention of TB recurrence |
| Target population(s) for clinical trial | Adults |
| People cured of active TB | |
COMPLETED TRIALS |
|
| Registry Number | CTRI/2019/01/017026 |
| Clinical Trial Sponsor | Indian Council of Medical Research |
| Clinical Trial Phase | Phase 3 |
| Primary endpoint(s) for this clinical trial | Prevention of TB disease |
| Target population(s) for clinical trial | Adults |
| Adolescents | |
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|
| Registry Number | NCT04351685 |
| Clinical Trial Phase | 3 |
| Clinical Trial Sponsor | Serum Institute of India Pvt. Ltd. |
| Primary endpoint(s) for this clinical trial | Prevention of Mtb infection or sustained infection |
| Target population(s) for clinical trial | Infants |
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| Registry Number | NCT02391415 |
| Clinical Trial Phase | Phase 2b |
| Clinical Trial Sponsor | Serum Institute of India Pvt. Ltd. |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Infants |
| Results/Publication | Safety 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 Number | NCT01479972 |
| Clinical Trial Phase | Phase 2a |
| Clinical Trial Sponsor | Vakzine Projekt Managment GmbH |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Infants |
| Results/Publication | Safety and Immunogenicity of the Recombinant Mycobacterium bovis BCG Vaccine VPM1002 in HIV-Unexposed Newborn Infants in South Africa |
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| Registry Number | NCT01113281 |
| Clinical Trial Phase | Phase 1 |
| Clinical Trial Sponsor | Vakzine Projekt Managment GmbH |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |
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| Registry Number | NCT00749034 |
| Clinical Trial Phase | Phase 1 |
| Clinical Trial Sponsor | Vakzine Projekt Managment GmbH |
| Primary endpoint(s) for this clinical trial | Safety |
| Target population(s) for clinical trial | Adults |