Advancing The Clinical Development Of Placental Malaria Vaccines In The Context Of Capacity Building and Use Of Digital Health Technologies

Placental malaria (PM) is a severe disease that affects a particularly vulnerable demographic group, pregnant women.

The burden of disease is high, threatening more than 100 million women every year and causing the death of an estimated 50,000 pregnant women and up to 200,000 infants.

An effective vaccine would be an attractive tool to control PM on its own, or to complement the existing yet imperfect tools.

ADVANCE-VAC4PM will build on the success of previously conducted first-in-human (phase I) clinical studies in Europe and Africa, assessing the two PM vaccine candidates PAMVAC and PRIMVAC.

The clinical trial results demonstrated that both adjuvanted vaccine candidates are safe and well-tolerated and induce good homologous immune responses demonstrating the feasibility of developing a PM vaccine.

However, prior to embarking on costly, large scale phase II clinical trials, it is essential to optimize the cross-reactivity of the vaccines.

Overall project objective is to advance the PM vaccine development and to broaden the immune response by i) increasing the vaccine-induced antibody level by using Virus-Like particles (VLP) to display the PM antigens or ii) by evaluating if a co-administration approach using PRIMVAC and PAMVAC-cVLP will increase cross-reactivity and cross-inhibitory antibody titers.

These activities will be embedded in capacity building activities e.g. workshops, training of MSc/PhD students, small competitive research grants to African early career researchers and development of immunology laboratory capacity. In preparation of future PM vaccine trials, digital tools will be evaluated.

Pregnancy registers will be developed and the feasibility and acceptability of using mobile applications for tracking pregnancy outcomes will be assessed. Modelling the cost-effectiveness, feasibility and acceptability of PM vaccines will further strengthen the case. Awareness on the need for a PM vaccine will be raised in stakeholder engagement activities.