Vaccine Info

VPM1002 Tuberculosis Vaccine

VPM1002 Tuberculosis Vaccine Description

The VPM1002 vaccine is a genetically modified BCG vaccine derived from the Mycobacterium bovis BCG subtype Prague characterized as rBCGÄureC::Hly+. VPM1002 contains weakened tuberculosis-like bacteria. These are genetically modified in such a way that immune cells can better recognize them.

VPM1002 is based on a vaccine called BCG, which was developed at the beginning of the 20th century. Studies on mice show that the BCG vaccine can protect not only against tuberculosis but also against viral infections of the respiratory tract. Accordingly, mice suffering from influenza have fewer influenza A viruses in their blood if they had previously been vaccinated with BCG. The animals thus showed less damage to the lungs.

According to further studies, vaccination with BCG also increases the animals' resistance to other viruses (e.g. herpes type 1 and 2). Apparently, vaccination with BCG also activates the immune system against a viral infection. In this way, the vaccine reduces the risk of severe disease progression and thus lowers the death rate.

In 2004, the Max-Planck-Gesellschaft granted the license for the vaccine to the company Vakzine Projekt Management (VPM). In 2012, the company began to further develop the vaccine together with the Serum Institute of India, one of the largest vaccine manufacturers worldwide. The company has now acquired a majority stake in VPM.

VPM1002 Tuberculosis Vaccine Indication

VPM1002 is indicated to prevent tuberculosis recurrence.

VPM1002 Tuberculosis Vaccine News

  • April 23, 2020 - 6,000 high-risk individuals will enter a trial to test the recombinant BCG vaccine. This study is approved by the Drug Controller General of India.
  • March 23, 2020 -  A Phase III study is investigating 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 will include 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 suffering from cancer of the bladder by using VPM1002. A Phase I study showed that the new vaccine is safe and well-tolerated. Patients suffering from cancer of the bladder, where cancer had returned after removal of the tumor and a subsequent standard BCG therapy, were then 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.
  • 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 has 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 Dosage

A single dose of VPM1002 or placebo will be administered to calculate the efficacy of the vaccine against TB recurrence.

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.

NCT03152903: Study to Check the Efficacy and Safety of Recombinant BCG Vaccine in Prevention of TB Recurrence in India. The study is designed as a multicenter, double-blinded, randomized, placebo-controlled trial with two groups of category 1 pulmonary TB patients who have successfully completed ATT and declared cured by bacteriological confirmation.