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DRUG:

VPM1002

i
Other names: VPM-1002BC, rBCG-delta-ureC-Hly, recombinant intravesical BCG, VPM 1002BC, VPM1002, VPM1002BC, Mycobacterium bovis BCG∆ureC::Hly+, VPM-1002
Associations
Trials
Company:
Max Planck Institute, SAKK, Serum Institute of India
Drug class:
Immunostimulant
Related drugs:
Associations
Trials
4ms
Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against TB in Pre-Adolescents Living With and Without HIV in South Africa (clinicaltrials.gov)
P1/2, N=0, Withdrawn, International Maternal Pediatric Adolescent AIDS Clinical Trials Group | N=480 --> 0 | Not yet recruiting --> Withdrawn
Enrollment change • Trial withdrawal
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
VPM1002
6ms
Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants (clinicaltrials.gov)
P3, N=6940, Active, not recruiting, Serum Institute of India Pvt. Ltd. | Trial primary completion date: Aug 2023 --> Dec 2025
Trial primary completion date
|
VPM1002
8ms
Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence (clinicaltrials.gov)
P2/3, N=2000, Active, not recruiting, Serum Institute of India Pvt. Ltd. | Trial completion date: Feb 2024 --> Jul 2024
Trial completion date
|
VPM1002
8ms
Safety and Immunogenicity of VPM1002 Vaccination or BCG Revaccination Against TB in Pre-Adolescents Living With and Without HIV in South Africa (clinicaltrials.gov)
P1/2, N=480, Not yet recruiting, International Maternal Pediatric Adolescent AIDS Clinical Trials Group | Trial completion date: Oct 2026 --> Jul 2027 | Trial primary completion date: Oct 2026 --> Jul 2027
Trial completion date • Trial primary completion date
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CD8 (cluster of differentiation 8) • CD4 (CD4 Molecule)
|
CD8 expression
|
VPM1002
11ms
Trial completion date • Trial primary completion date
|
cisplatin • Tecentriq (atezolizumab) • gemcitabine • VPM1002
over1year
Novel sequential treatment strategy for patients with muscle-invasive bladder cancer (MIBC): intravesical recombinant BCG, followed by neoadjuvant chemoimmunotherapy, radical cystectomy plus pelvic lymphadenectomy and adjuvant immunotherapy - protocol of a multicentre, single arm phase 2 trial (SAKK 06/19). (PubMed, BMJ Open)
Intravesical recombinant BCG (rBCG: VPM1002BC) is applied weekly for three instillations followed by four cycles of neoadjuvant cisplatin/gemcitabine every 3 weeks. Atezolizumab 1200 mg every 3 weeks is started together with rBCG and given for four cycles...Results will be made available by publication. NCT04630730.
P2 data • Journal
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PD-L1 (Programmed death ligand 1)
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cisplatin • Tecentriq (atezolizumab) • gemcitabine • VPM1002
over4years
Results of the phase I open label clinical trial SAKK 06/14 assessing safety of intravesical instillation of VPM1002BC, a recombinant mycobacterium Bacillus Calmette Guérin (BCG), in patients with non-muscle invasive bladder cancer and previous failure of conventional BCG therapy. (PubMed, Oncoimmunology)
Plasma levels of TNFα significantly increased after treatment and blood-derived CD4+ T cells stimulated with PPD demonstrated significantly increased intracellular GM-CSF and IFN expression. The intravesical application of VPM1002BC is safe and well tolerated by patients and results in a potential Th1 weighted immune response.
Clinical • P1 data • Journal
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CSF2 (Colony stimulating factor 2)
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CSF2 elevation • IFNA1 expression
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VPM1002