VPM1002 / Max Planck Institute, SAKK, Serum Institute of India - LARVOL DELTA

Status of Tuberculosis Vaccines Development in Clinical Trials (PubMed, Jugan Geongang Gwa Jilbyeong) - "The recombinant protein-based M72/AS01E vaccine has been mentioned as a potential vaccine, and is currently recruiting subjects for a Phase 3 clinical trial. In addition, recombinant protein-based GemTBvac and whole cell-based MIP, MTBVAC, and VPM1002 are in Phase 3 clinical trials. While several platform-based TB vaccine candidates are in clinical trials; however, the antigens contained in these candidates are often redundant and limited. To diversify the TB vaccine clinical pipeline, it is necessary to continue research to identify new antigens, the development of preclinical animal models for efficacy evaluation, and the identification of valid endpoints through the analysis of clinical trial results are necessary."

Journal • Review • Infectious Disease • Novel Coronavirus Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Overcoming Treatment Challenges in HIV-Associated Mycobacterial Diseases: New Therapeutic Frontiers. (PubMed, Int J Mol Sci) - "Beyond established regimens, we highlight host-directed strategies such as metformin, glutathione augmentation, mTOR modulation, and vitamin D; immunotherapies including interferon-γ, GM-CSF, and IL-7; and therapeutic vaccines (M72/AS01E, MTBVAC, VPM1002) as promising adjuncts. Distinct from guideline-focused overviews, this review emphasizes non-tuberculous mycobacterial disease (NTM, including MAC) and leprosy in PLWH and synthesizes host-directed and adjunctive strategies with their translational prospects, including ART compatibility and IRIS. By integrating TB, NTM, and leprosy across the HIV care continuum, we highlight opportunities not treated in detail elsewhere-particularly HDT-enabled approaches and implementation considerations in PLWH."

Journal • Review • Human Immunodeficiency Virus • Infectious Disease • Nontuberculous Mycobacterial Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CSF2 • IFNG • IL7

ResQ132Ex-NMIBC: EXPANDED ACCESS OF RECOMBINANT MYCOBACTERIUM BACILLUS CALMETTE-GUERIN IN NON-MUSCLE INVASIVE BLADDER CANCER (SUO 2025) - P, P1/2 | "In the SAKK06/14 trial, rBCG VPM1002BC was demonstrated to be efficacious and safe in NMIBC recurrence after conventional BCG therapy [Rentch 2022]...As of August 5, 2025, over 150 patients have received expanded access to rBCG at 25+ Urology locations in the United States. "

Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urology

Intravesical recombinant BCG followed by perioperative chemo-immunotherapy (chemo-IO) for patients with muscle-invasive bladder cancer (MIBC): Interim analysis of SAKK 06/19 study (ESMO 2025) - P2 | "We previously investigated a recombinant BCG vaccine (rBCG, VPM1002BC) demonstrating good safety and efficacy (SAKK 06/14)...Atezolizumab (Atezo) 1200 mg is administered on day 1 and then 4 times every 3 weeks (q3w). Cisplatin and gemcitabine start on day 22 and are given for 4 cycles q3w followed by radical cystectomy (RC)...Conclusions The combination of intravesical rBCG with perioperative chemo-IO was feasible and well-tolerated without unexpected toxicities. The interim analysis met predefined efficacy and safety criteria and the trial continues enrollment into stage 2."

Clinical • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

Adult TB vaccine: Possible novel tool to end TB (MTS 2025) - "We will discuss the immunopathogenesis of TB and how it informs vaccine development, highlighting key vaccine candidates such as M72/AS01E, VPM1002, and BCG revaccination strategies. Furthermore, the lecture will address how adult TB vaccination could synergize with existing TB control strategies, including latent TB treatment, diagnostics, and public health interventions. Special focus will be given to implementation considerations, including population targeting, delivery logistics, and cost-effectiveness in low- and middle-income countries."

Clinical • Infectious Disease • Respiratory Diseases • Tuberculosis

Sex Differences in Vaccine-Induced Immunity and Protection Against Mycobacterium tuberculosis. (PubMed, J Infect Dis) - "In this study, we vaccinated male and female C57BL/6 mice with BCG and 2 recombinant derivatives, VPM1002 and BCGΔBCG1419c, and assessed their protection against Mycobacterium tuberculosis (Mtb) HN878...Vaccination of males with BCGΔBCG1419c, but not BCG, enhanced CD8 T-cell and B-cell recall responses in vaccine-draining lymph nodes, and reduced lung inflammation after Mtb challenge. These findings underscore the impact of sex differences on vaccine efficacy and suggest that future research should consider sex as a biological variable to optimize TB vaccination strategies."

Journal • Infectious Disease • Inflammation • Pneumonia • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence (clinicaltrials.gov) - P2/3 | N=2000 | Completed | Sponsor: Serum Institute of India Pvt. Ltd. | Active, not recruiting ➔ Completed

Trial completion • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Evaluation of Efficacy and Safety of VPM1002 in Comparison to BCG in Prevention of Tb Infection in Infants (clinicaltrials.gov) - P3 | N=6940 | Completed | Sponsor: Serum Institute of India Pvt. Ltd. | Active, not recruiting ➔ Completed | Trial completion date: Dec 2025 ➔ Oct 2024 | Trial primary completion date: Dec 2025 ➔ Oct 2024

Trial completion • Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

PreVenTB trial: protocol for evaluation of efficacy and safety of two vaccines VPM1002 and Immuvac (Mw) in preventing tuberculosis (TB) in healthy household contacts of newly diagnosed sputum smear-positive pulmonary TB patients: phase III, randomised, double-blind, three-arm placebo-controlled trial. (PubMed, BMJ Open) - "The results of this clinical trial will be presented at scientific conferences and disseminated through publications in peer-reviewed journals, conference presentations and shared with Ministry of Health and Family Welfare, policy-makers and other stakeholders. CTRI/2019/01/017026."

Clinical • Clinical protocol • Journal • P3 data • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8

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 | Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group | N=480 ➔ 0 | Not yet recruiting ➔ Withdrawn

Enrollment change • Trial withdrawal • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8

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 | Sponsor: Serum Institute of India Pvt. Ltd. | Trial primary completion date: Aug 2023 ➔ Dec 2025

Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

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 | Sponsor: Serum Institute of India Pvt. Ltd. | Trial completion date: Feb 2024 ➔ Jul 2024

Trial completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

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 | Sponsor: 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 • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8

Intravesical recombinant BCG followed by perioperative chemo-immunotherapy for patients with muscle-invasive bladder cancer (MIBC): A multicenter, single arm phase 2 trial (SAKK 06/19). (ASCO-GU 2024) - P2 | "Recently, a novel recombinant BCG vaccine (VPM1002BC) has been developed and a clinical study in BCG-refractory NMIBC (SAKK 06/14, Eur Urol Oncol...Atezolizumab (atezo) 1200mg is given on day 1 and then every 3 weeks (q3w) for four times. Chemotherapy with cisplatin (70mg/m2 day 1) and gemcitabine (1000mg/m2 day 1 & 8) q3w is started on day 22 and given for four cycles followed by radical cystectomy and lymphadenctomy...Accrual to the study is currently ongoing (NCT04630730). Clinical trial information: NCT04630730."

Clinical • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

SAKK 06/19: Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC (clinicaltrials.gov) - P2 | N=5 | Recruiting | Sponsor: Swiss Group for Clinical Cancer Research

Trial completion date • Trial primary completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

SAKK 06/19: Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC (clinicaltrials.gov) - P2 | N=5 | Recruiting | Sponsor: Swiss Group for Clinical Cancer Research | Active, not recruiting ➔ Recruiting

Enrollment open • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

SAKK 06/19: Intravesical Recombinant BCG Followed by Perioperative Chemo-immunotherapy for Patients With MIBC (clinicaltrials.gov) - P2 | N=5 | Active, not recruiting | Sponsor: Swiss Group for Clinical Cancer Research | Suspended ➔ Active, not recruiting | N=46 ➔ 5

Enrollment change • Enrollment closed • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor

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 | Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group | Trial completion date: Mar 2026 ➔ Oct 2026 | Initiation date: Sep 2023 ➔ Mar 2024 | Trial primary completion date: Mar 2026 ➔ Oct 2026

Trial completion date • Trial initiation date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8

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) - P2 | "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."

Journal • P2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urethral Cancer • Urology • Urothelial Cancer • PD-L1

SAKK 06/14: VPM1002BC in Recurrent Non-muscle Invasive Bladder Cancer (clinicaltrials.gov) - P1/2 | N=39 | Completed | Sponsor: Swiss Group for Clinical Cancer Research | Active, not recruiting ➔ Completed | Trial completion date: Jun 2023 ➔ Mar 2023

Trial completion • Trial completion date • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

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 | Sponsor: Serum Institute of India Pvt. Ltd. | Recruiting ➔ Active, not recruiting | Trial completion date: May 2022 ➔ Feb 2024 | Trial primary completion date: Feb 2022 ➔ Feb 2024

Enrollment closed • Trial completion date • Trial primary completion date • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis

Safety and Immunogenicity of Recombinant Bacille Calmette-Guérin Strain VPM1002 and Its Derivatives in a Goat Model. (PubMed, Int J Mol Sci) - "Flow cytometry analysis of IFN-γ production by CD4, CD8, and γδ T cells showed that CD4 T cells of VPM1002- and NUOG-vaccinated goats produced more IFN-γ compared to BCG-vaccinated and mock-treated animals. In summary, the subcutaneous application of VPM1002 and NUOG induced anti-tuberculous immunity, while exhibiting a comparable safety profile to BCG in goats."

Journal • Hematological Disorders • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8 • IFNG

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 | Sponsor: International Maternal Pediatric Adolescent AIDS Clinical Trials Group | Trial completion date: Sep 2025 ➔ Mar 2026 | Initiation date: Mar 2023 ➔ Sep 2023 | Trial primary completion date: Sep 2025 ➔ Mar 2026

Trial completion date • Trial initiation date • Trial primary completion date • Human Immunodeficiency Virus • Infectious Disease • Pulmonary Disease • Respiratory Diseases • Tuberculosis • CD4 • CD8

3-year results of a phase I/II single arm clinical trial of recombinant Bacillus Calmette-Guérin (BCG) VPM1002BC immunotherapy in non-muscle-invasive bladder cancer recurrence after conventional BCG therapy – SAKK 06/14 (EAU 2022) - No abstract available

Clinical • P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer

[VIRTUAL] Results of a phase I/II single arm clinical trial assessing the recombinant Bacillus Calmette-Guérin (rBCG) VPM1002BC in patients with non muscle-invasive bladder cancer recurrence after BCG induction with or without BCG maintenance therapy – SAKK 06/14 (EAU 2021) - No abstract available

Clinical • P1/2 data • Bladder Cancer • Genito-urinary Cancer • Oncology • Solid Tumor • Urothelial Cancer