EVI and its partners have been spearheading global efforts for the development of two promising VAR2CSA-derived PM vaccine candidates: PRIMVAC, developed by Inserm, (France) and PAMVAC, developed by the University of Copenhagen (Denmark). Both vaccine candidates use similar but complementary approaches and consist of a single recombinant protein comprising the placental binding region of VAR2CSA.

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A long road...

Previous funds from the German Federal Ministry of Education and Research through Kreditanstalt für Wiederaufbau, the Irish Aid, the Danish National Advanced Technology Foundation and the European Commission (PRIMALVAC, PAMCPH, PlacMalVac and PlacID projects) supported the preclinical assessment and the conduct of two independent Phase I clinical trials in Europe and Africa [1],[2]. Results from clinical trials demonstrated that the two PM vaccine candidates PAMVAC and PRIMVAC are safe, well-tolerated and induce good homologous immune responses.

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Clinical Development of Placental Malaria Vaccine Candidates

Building on these successes, two new projects coordinated by EVI have recently started to accelerate the development of a safe, affordable and effective vaccine against PM. The VAC4PM project is funded by the Japanese Global Health Innovation Technology (GHIT) Fund and seeks to further characterize the longevity of the PRIMVAC-induced immune response, as well as the capacity of the vaccine to boost and broaden a naturally acquired immune response. Another aspect of the project is to undertake the pre-clinical development of PAMVAC-CLP. PAMVAC-CLP is an improved version of PAMVAC, where a capsid-like particle (CLP) will be added as backbone, potentially improving immunogenicity, cross-reactivity and longevity of the induced immune response.

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Advancing the clinical development of placental malaria vaccines in the context of capacity building and use of digital health technologies

The ADVANCE-VAC4PM project is funded by the European Commission and will complement the activities of the VAC4PM project and advance the clinical development of PRIMVAC and PAMVAC, i) by bringing the PAMVAC-cVLP vaccine candidates up to clinical testing in the endemic population and ii) by evaluating co-administration of PRIMVAC and PAMVAC-cVLP with the ultimate goal to improve and broaden the vaccine-induced immune response. The clinical trial activities will be embedded in capacity building efforts including workshops, training of MSc/PhD students, a mentorship program for African early career researchers and strengthening of clinical and immunology laboratory capacity. Digital tools will be developed for monitoring pregnancy outcomes in preparation of future efficacy trials. Modelling the cost-effectiveness, feasibility and acceptability of placental malaria vaccines will also be conducted.