Project: A multicenter Phase III double-blind, randomized, controlled study to evaluate the efficacy and safety of VPM1002 in comparison to BCG

Acronym priMe (Reference Number: RIA2016V-1645)
Duration 01/05/2018 - 30/04/2023
Project Topic Globally, vaccination with BCG fails to stop spread of Tuberculosis (TB). However, in children BCG can protect against, or at least ameliorate, severe forms of systemic TB, particularly TB meningitis. To interrupt transmission of disease, highly contagious pulmonary forms of TB need to also be targeted by vaccination. BCG unfortunately fails to achieve this. In addition, the current BCG shortage crisis endangers global child health and further highlights the need for a novel TB vaccine. The aim of the development of VPM1002 is to replace BCG by a well-tolerated vaccine that has superior efficacy and a better safety profile. Pre-clinical and clinical data show that VPM1002 is safer and is more immunogenic than standard BCG. A phase II clinical trial in the target population of HIV-exposed and HIV-unexposed infants has recently completed recruitment in South Africa (416 infants recruited) and is investigating safety and immunogenicity of VPM1002 in these infants. No vaccine-related serious adverse events have been registered to date. The proposed phase III trial plans to recruit approximately 10.000 healthy male and female newborn infants, who will be vaccinated with either standard BCG or VPM1002. The co-primary objectives are to demonstrate that vaccination with VPM1002 is non-inferior to BCG in providing protection against incident TB disease/ disease due to infection with other virulent mycobacteria of the tuberculosis family and to demonstrate that vaccination with VPM1002 is superior to BCG with regard to the incidence of Grade 3 and 4 adverse reactions, vaccination-related generalized lymphadenopathy and/or severe BCG disease/disease due to infection with other mycobacteria. Secondary endpoints will explore the safety and efficacy parameters in HIV-exposed vs. HIV-unexposed infants. As explorative endpoints, immunogenicity will be assessed by determining key immunological parameters, like multi-functional T cells by intracellular staining of cytokines, antibody production by B cells and transcriptome analysis of involved blood cells in a subset of participants. After this pivotal phase III trial, the developers of VPM1002 will apply for market authorization in order to make this novel vaccine available to children in Sub-Saharan countries and worldwide. The manufacturing process of VPM1002 is streamlined and can be scaled up to meet the worldwide demand, which is in contrast to the current BCG.
Network EDCTP2
Call Vaccines for poverty-related diseases (PRDs)

Project partner

Number Name Role Country
1 Vakzine Projekt Management GmbH (VPM) Coordinator Germany
2 Stichting tuBerculosis Vaccine Initiative (TBVI) Partner Netherlands, The
3 Stellenbosch University Partner South Africa
4 Wits Health Consortium (Pty) Ltd Partner South Africa
5 University of Cape Town Partner South Africa
6 Centre de Recherches Médicales de Lambaréné Partner Gabon
7 Ifakara Health Institute Trust (IHI) Partner Tanzania, United Republic of
8 Eberhard Karls Universität Tübingen Partner Germany
9 Max-Planck-Gesellschaft zur Foerderung der Wissenschaften B.V. (MPG-MPII) Partner Germany
10 Uganda National Health Research Organisation (UNHRO) Partner Uganda
11 Kenya Medical Research Institute (KEMRI) Partner Kenya
12 Makerere University Partner Uganda
13 Sefako Makgatho Health Sciences University (SMU) Partner South Africa
14 Serum Institute of India Pvt. Ltd. Partner India