PriMe – A multicentre phase III double-blind, randomised, controlled study to evaluate the efficacy and safety of VPM1002 in comparison to BCG

• Duration: 2018 – 2024
• Funded by the EDCPT
• Coordinated by VPM SII Europe
• 16 partners

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.

PriMe, funded by EDCTP and Serum Institute of India is a pivotal phase III trial. Approximately 7,000 healthy male and female newborn infants in South Africa, Tanzania, Kenya, Uganda and Gabon are planned to be recruited. The study cohort will consist of HIV-unexposed as well as HIV-exposed newborn infants vaccinated with either BCG SII or VPM1002 to evaluate efficacy and safety, also in immune-compromised populations.

After successfully conducting this pivotal phase III trial, the development of VPM1002 aims to apply for marketing authorization in order to make this novel vaccine available to newborn infants in Sub-Saharan countries and worldwide.  The duration of this project was 5 years.

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