Press release on the results of a novel tuberculosis vaccine tested in a large phase III trial against severe respiratory infectious diseases

VPM1002 Vaccination as Prophylaxis Against Severe Respiratory Infectious Diseases

01 December 2022
VPM Hannover/Germany and Serum Institute of India
Results of a novel tuberculosis vaccine tested in a large phase III trial against severe respiratory infectious diseases.
The course of respiratory infectious disease pandemics, e.g. Covid-19 or Influenza, will strongly depend on how quickly medications or specific vaccines against the pathogens are available. Researchers wanted to investigate in a phase III trial whether the vaccine candidate VPM1002, originally developed against tuberculosis by scientists at the Max Planck Institute for Infection Biology, is also protective against an infection with the novel SARS-CoV-2. The large-scale study has been carried out at several hospitals in Germany and included older people that are susceptible to severe course of the disease. VPM1002 could thus help bridge the time until a vaccine is available during future pandemics. The vaccine induces not only specific immunity against tuberculosis, but at the same time mobilizes innate immunity, which is immediately effective against various pathogens.  
VPM1002 is a genetically modified Bacille Calmette–Guérin (BCG), a tuberculosis vaccine developed in the beginning of the 20th century, with improved safety and immunogenicity profile. This vaccine is currently evaluated in several phase III trials for safety and efficacy against tuberculosis in different indications. Alike BCG, VPM1002 has unspecific and boosting effects on the immune system, a mechanism referred to as “trained immunity”.
“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 tuberculosis pathogen but has also the ability to train the immunity”, says 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 the current randomized, double-blind, placebo-controlled trial the effect of VPM1002 on disease severity of respiratory tract infections in elderly people was assessed during the SARS-CoV-2 pandemic in Germany. The trial was conducted in a phase of the pandemic with rigorous statutory hygienic measures and an unexpected low number of overall infection rate. Nevertheless, after 240 days of follow-up, VPM1002-vaccinated compared to placebo-treated participants had numerically less days with severe respiratory disease, less days with fever as well as a trend towards less hospital and ICU admissions. The observation is further underlined by a subgroup analysis of participants not receiving a SARS-CoV-2-specific vaccine where days with severe respiratory tract infection was remarkably reduced.
The effect of trained immunity seen with VPM1002 is in line with trials performed with BCG and other live vaccines and might even be more pronounced. VPM1002 is safer than BCG and could contribute to the reduction of disease burden from respiratory diseases in the elderly population.
“VPM1002 could pose a first line protection to newly arising respiratory pathogens in the future and thereby covering the gap until specific vaccines are available” explained Umesh Shaligram, Executive Director, Serum Institute of India.
VPM1002 shows the potential to protect against a broad-spectrum of respiratory tract infections, not only tuberculosis, especially in vulnerable populations like the elderly in whom disease severity is often more prominent.
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. 
Dr. Leander Grode, CEO
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