Vaccine Info

VPM1002 Tuberculosis Vaccine

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Last reviewed
February 9, 2023
Fact checked by
Robert Carlson, MD

VPM1002 Tuberculosis Vaccine 2023

The VPM1002 vaccine candidate is a genetically modified recombinant Bacille Calmette–Guérin (BCG) vaccine derived from the Mycobacterium Bovis BCG Danish subtype Prague characterized as rBCGÄureC::Hly+. VPM1002 contains weakened tuberculosis (TB)-like bacteria. These are genetically modified in such a way that immune cells can better recognize them. 

The VPM1002 vaccine candidate expressing listeriolysin and deficient in urease is generated in the genetic background of BCG Prague, offering a better safety profile than other BCG versions due to the lack of the RD2 genome segment. This vaccine's urease C gene replaces the listeriolysin O encoding gene from Listeria monocytogenes. By reducing urease C, phagosome acidification can occur, promoting phagolysosome fusion while also providing the optimal low pH for listeriolysin O stability.

VPM1002 was created in response and investigated for preventing pulmonary TB in newborns and TB recurrence in adults through post-exposure immunization. VPM1002 facilitates mycobacterial antigens being released into the cytosol while also triggering autophagy, inflammasome activation, and apoptosis because of antigens and bacterial DNA being released into the cytosol of the host cell due to Listeriolysin O expression in this vaccine. In addition, mycobacterial antigen accessing the cytosol also improves antigen presentation.

The results from a double-blind, randomized, active-controlled phase 2 study were recently conducted in South Africa and published in The Lancet Infectious Disease on June 27, 2022. The researcher's Interpretation: VPM1002 was less reactogenic than BCG. Both vaccines were immunogenic, although responses were higher with the BCG vaccine.

Serum Institute of India Pvt. Ltd. (SSI) VPM1002 is based on a BCG vaccine developed at the beginning of the 20th century. In 2004, the Max-Planck-Gesellschaft granted the license for the vaccine candidate to Vakzine Projekt Management (VPM). In 2012, the company began developing the vaccine with the SSI, which acquired a majority stake in VPM. VPM1002 is currently being studied for efficacy and safety in multicentric phase 3 clinical trials. DrugBank Accession Number: DB15801.

Serum Institute of India was founded in 1966 by Dr. Cyrus Poonawalla with the aim of manufacturing life-saving immuno-biologicals.

VPM1002 Indication

BCG vaccination activates the human immune system against viral infection, reducing the risk of severe disease progression and thus lowering the death rate. VPM1002 is indicated to prevent tuberculosis recurrence. The WHO Global TB Report 2021 provides a comprehensive and up-to-date assessment of the TB epidemic. Previous Global TB reports are accessed at this WHO link.

VPM1002 Dosage

A single dose of VPM1002 calculates the vaccine's efficacy against TB recurrence.

VPM1002 Side Effects

A phase 2 study found that VPM1002 was not associated with serious safety concerns.

VPM1002 Vaccine News 2023

December 1, 2022 - “We decided from the beginning to improve classical BCG genetically in a way to exploit all its advantages. VPM1002 has turned out not only to be specific against the TB pathogen but has also the ability to train the immunity”, commented Prof. Dr. Stefan Kaufmann, the inventor of VPM1002 and head of the Emeritus Group Immunology at the Max Planck Institute for Multidisciplinary Sciences in Goettingen, Germany, in a press release.

June 27, 2022 - The Lancet Infectious Diseases published: A next-generation BCG vaccine moves forward.

April 13, 2022 - University Health Network, Toronto - Efficacy and Safety of VPM1002.

January 28, 2020 - Bacillus Calmette-Guérin Therapy for Bladder Cancer: An Update.

July 27, 2020 - The Serum Institute of India is conducting a phase III clinical trial of BCG vaccine candidate VPM1002 to evaluate its ability to reduce infection and severe disease outcomes.

April 23, 2020 - About 6,000 high-risk individuals will enter a phase 3 clinical trial to test the recombinant BCG vaccine. The Drug Controller General approved this study of India.

February 20, 2020 - A clinical study (SAKK 06/14) under the direction of Cyrill A. Rentsch, University Hospital Basel, Switzerland, together with the Swiss Group for Clinical Cancer Research (SAKK), is now investigating whether it is possible to avoid removing bladders from patients who have cancer of the bladder by using VPM1002. 

January 21, 2021 - IAVI announced it is partnering with the study sponsor Serum Institute of India Pvt. Ltd. and Vakzine Projekt Management GmbH, a German development consulting firm biopharmaceutical industry and a subsidiary of SIIPL, to conduct the priMe study. priMe is a multicenter, double-blind, randomized, active-controlled Phase III study to evaluate the efficacy and safety of the vaccine candidate VPM1002 compared to BCG for preventing Mycobacterium tuberculosis infection in HIV-exposed and HIV-unexposed newborn infants. Study sites are in Gabon, Kenya, South Africa, Tanzania, and Uganda.

September 19, 2020 - The Recombinant Bacille Calmette–Guérin Vaccine VPM1002: Ready for Clinical Efficacy Testing.

August 6, 2019 – The Indian Council of Medical Research announced it had launched India's first large-scale clinical study for new TB vaccines. The TB vaccine in this new clinical study offers a chance to contain the accelerating spread of multi-drug-resistant TB. Treating TB requires a multi-drug course of treatment lasting up to 6 months and longer when treating drug-resistant TB.

VPM1002 Vaccine Clinical Trials

The vaccine is being tested in a Phase III study on adult volunteers in India. In mice, VPM1002 gave better protection than BCG against aerosol infection with M tuberculosis and improved survival in severe combined immunodeficiency mice. The study by Cotton and colleagues bridged from the original hygromycin-resistant formulation of VPM1002 to a hygromycin-sensitive formulation.

June 2022 - Safety and immunogenicity of VPM1002 versus BCG in South African newborn babies: a randomized, phase 2 non-inferiority double-blind controlled trial - Between June 4, 2015, and Oct 16, 2017, 416 eligible newborn babies were randomly assigned and received study vaccine. Seven (2%) of 312 participants in the VPM1002 group had a grade 3–4 vaccine-related adverse reaction or lymphadenopathy of 10 mm or greater in diameter compared with 34 (33%) of 104 participants in the BCG group (risk difference −30·45% [95% CI −39·61% to −21·28%]; pnon-inferiority<0·0001); VPM1002 was thus non-inferior to BCG for the primary outcome. Incidence of severe injection site reactions was lower with VPM1002 than BCG: scarring occurred in 65 (21%) participants in the VPM1002 group versus 77 (74%) participants in the BCG group (p<0·0001); ulceration occurred in one (<1%) versus 15 (14%; p<0·0001); and abscess formation occurred in five (2%) versus 23 (22%; p<0·0001). Restimulated IFNγ concentrations were lower in the VPM1002 group than the BCG group at week 6, week 12, month 6, and month 12. The percentage of multifunctional CD4+ T cells was higher in the VPM1002 group than the BCG group at day 14 but lower at week 6, week 12, month 6, and month 12. The percentage of multifunctional CD8+ T cells was lower in the VPM1002 group than the BCG group at week 6, week 12, and month 6, but did not differ at other time points. Interpretation: VPM1002 was less reactogenic than BCG and was not associated with any serious safety concerns. Both vaccines were immunogenic, although responses were higher with the BCG vaccine. VPM1002 is currently being studied for efficacy and safety in a multicentric phase 3 clinical trial in babies in sub-Saharan Africa.

Clinical Trials

No clinical trials found