#priMe infants to stop TB
Tuberculosis (TB) is one of the top 10 causes of death worldwide. An estimated 10 million people fell ill with TB in 2018 with approximately 1.5 million dying from the disease. In children, BCG vaccination can protect against, or at least ameliorate, severe forms of systemic TB, particularly TB meningitis. Ultimately, to interrupt transmission of the disease, highly contagious pulmonary forms of TB also need to be targeted by vaccination. The priMe project evaluates the efficacy and safety of a new vaccine candidate against TB.
In 1993, the World Health Organization (WHO) declared tuberculosis (TB) a global emergency. Approx. 1.7 billion people are infected and 10 million people are estimated to have fallen ill with TB in 2017. In the same year approx. 1.5 million died because of TB; among them 205,000 children (aged 0-14 years). South Africa and other Sub-Saharan countries belong to the group of “high-burden” TB countries with an estimated total incidence of 301,000 TB cases in 2018 in South Africa alone.
In children BCG can protect against, or at least ameliorate, severe forms of systemic TB, particularly TB meningitis.
VPM1002 is an innovative live vaccine against TB, based on the well-known Mycobacterium bovis (M. bovis) Bacille Calmette-Guérin (BCG) strain which has been administered approximately 4 billion times worldwide.
The genetic modifications of VPM1002, namely introduction of listeriolysin while simultaneously deleting the gene for urease C in the BCG genome, are aiming for better recognition by the host immune system.
News and Press
It is our pleasure to announce that the first clinical center in South Africa has been initiated in a large phase III trial (priMe) to assess the efficacy and safety of the novel TB vaccine – VPM1002 - in comparison with BCG in healthy newborn infants. The clinical centers in Tanzania, Uganda and Gabon will follow in the next weeks.
It is our pleasure to announce that the first participant has been enrolled on 9th of November 2020 in the priMe phase III trial to assess the efficacy and safety of the novel TB vaccine – VPM1002 - in comparison with BCG in healthy newborn infants.