VPM1002 Tuberculosis Vaccine Description
The VPM1002 vaccine is a genetically modified recombinant BCG vaccine derived from the Mycobacterium Bovis BCG 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. BCG vaccination activates the human immune system against viral infection, reducing the risk of severe disease progression and thus lowering the death rate. VPM1002 has been created in response and investigated for preventing pulmonary TB in newborns and TB recurrence in adults through post-exposure immunization.
The VPM1002 vaccine candidate expressing listeriolysin and deficient in urease is generated in the genetic background of BCG Prague as it has a better safety profile than some other BCG versions due to the lack of the RD2 genome segment. This vaccine's urease C gene is replaced with 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.
Serum Institute of India Pvt. Ltd. (SSI) VPM1002 is based on a BCG vaccine, which was 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 a multicentric phase 3 clinical trial in infants in sub-Saharan Africa.
Immunization with an older BCG vaccine is partially effective in infants, reducing the incidence of miliary and tuberculosis meningitis, but is less effective against pulmonary tuberculosis. 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.
According to previous studies, vaccination with BCG also increases animal resistance to other viruses (e.g., herpes type 1 and 2).
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. Mycobacterial antigen accessing the cytosol also improves antigen presentation. 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 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.
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 Tuberculosis Vaccine News
July 27, 2021 - Scientists from the Hackensack Meridian Center for Discovery and Innovation (CDI) were awarded $6.4 million from the National Institutes of Health (NIH) to pursue an innovative new TB vaccine concept. The team proposes a different strategy than most other researchers: increase the quantity and life span of the body's B cells to fight the TB bacteria. Using high parameter flow cytometry available at the CDI, Gengenbacher and his team have identified a novel type of B-cells that contribute to TB infection control. The translational approach involves CDI scientists genetically engineering BCG to promote B cell development and survival, presumably including their newly discovered protective B cell subsets. Consequently, the scientists hypothesize the body will effectively fight off the bacteria.
January 28, 2020 - Bacillus Calmette-Guérin Therapy for Bladder Cancer: An Update.
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.
March 23, 2020 - A Phase III study investigates whether the vaccine candidate VPM1002, originally developed against tuberculosis by scientists at the Max Planck Institute for Infection Biology, is also effective against infection with SARS-CoV-2. The large-scale study is to be carried out at several hospitals in Germany and includes older people and health care workers. Both groups are particularly at risk from the disease. VPM1002 could thus help bridge the time until a vaccine specifically effective against SARS co-virus 2 is available.
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), are now investigating whether it is possible to avoid removing bladders from patients who have cancer of the bladder by using VPM1002. A Phase I study showed that the new vaccine is safe and well-tolerated. Patients who have cancer of the bladder, where cancer had returned after removing the tumor and a subsequent standard BCG therapy, were treated in a Phase II study. "Over 49 percent of the patients treated with VPM1002 were free from tumors in the bladder after 60 weeks," says Leander Grode, who developed VPM1002 together with Stefan Kaufmann and is now Managing Director of VPM. Tumor-free patients avoid the removal of the bladder.
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 the prevention of 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 tuberculosis (TB) vaccines. The TB vaccine included 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 Tuberculosis Vaccine Clinical Trial
The vaccine is currently being tested in a further Phase III study on adult volunteers in India. It should be completed by mid-2020. "Results to date show that vaccination with VPM1002 is safe and more effective than standard vaccination with BCG", says Stefan H.E. Kaufmann.