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VPM1002
VPM1002 is a live attenuated recombinant tuberculosis vaccine that enhances immune response by expressing listeriolysin O to improve intracellular antigen presentation.
VPM1002 is a live attenuated recombinant tuberculosis vaccine that enhances immune response by expressing listeriolysin O to improve intracellular antigen presentation. Used for Tuberculosis prevention in BCG-vaccinated and unvaccinated populations, Tuberculosis prevention in HIV-positive individuals.
At a glance
| Generic name | VPM1002 |
|---|---|
| Also known as | recombinant BCG for TB, Mycobacterium bovis rBCGΔureC::hly |
| Sponsor | Serum Life Science Europe GmbH |
| Drug class | Live attenuated recombinant vaccine |
| Target | Mycobacterium tuberculosis antigens (Ag85B, TB10.4) |
| Modality | Biologic |
| Therapeutic area | Immunology / Infectious Disease |
| Phase | Phase 3 |
Mechanism of action
VPM1002 is derived from the BCG vaccine but has been genetically modified to delete the ureC gene and insert the listeriolysin O (LLO) gene from Listeria monocytogenes. This modification enhances the vaccine's ability to trigger both CD4+ and CD8+ T-cell responses by improving antigen escape from the phagolysosome and promoting cross-presentation. The vaccine is designed to provide superior protection against tuberculosis compared to standard BCG.
Approved indications
- Tuberculosis prevention in BCG-vaccinated and unvaccinated populations
- Tuberculosis prevention in HIV-positive individuals
Common side effects
- Local injection site reactions (erythema, induration)
- Fever
- Lymphadenitis
Key clinical trials
- Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against TB in Pre-Adolescents Living With and Without HIV in South Africa (PHASE1, PHASE2)
- Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence (PHASE2, PHASE3)
- Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants (PHASE3)
- VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer (PHASE1, PHASE2)
- Efficacy and Safety of VPM1002 in Reducing SARS-CoV-2 (COVID-19) Infection Rate and Severity (PHASE3)
- Study to Assess VPM1002 in Reducing Hospital Admissions and/or Severe Respiratory Infectious Diseases in Elderly in COVID-19 Pandemic (PHASE3)
- Study to Assess VPM1002 in Reducing Healthcare Professionals' Absenteeism in COVID-19 Pandemic (PHASE3)
- Study to Evaluate the Safety and Immunogenicity of VPM1002 in Comparison With BCG in HIV-exposed/-Unexposed Newborn Infants in South Africa (PHASE2)
Primary sources
Every claim on this page is sourced from regulatory or scientific primary sources. See our editorial policy for full methodology.
| Source | Used for |
|---|---|
| ClinicalTrials.gov | Trial enrolment, design, endpoints, results |
Competitive intelligence
For the full competitive landscape — auto-detected comparators, recent regulatory actions across the set, upcoming PDUFA, patent timeline, sponsor landscape:
- VPM1002 CI brief — competitive landscape report
- VPM1002 updates RSS · CI watch RSS
- Serum Life Science Europe GmbH portfolio CI