ADVANCE-VAC4PM | Advancing The Clinical Development Of Placental Malaria Vaccines In The Context Of Capacity Building and Use Of Digital Health Technologies

Summary
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.
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More information & hyperlinks
Web resources: https://cordis.europa.eu/project/id/101057882
Start date: 01-06-2022
End date: 31-05-2027
Total budget - Public funding: 9 999 995,00 Euro - 9 999 995,00 Euro
Cordis data

Original description

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.

Status

SIGNED

Call topic

HORIZON-HLTH-2021-DISEASE-04-03

Update Date

09-02-2023
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Horizon Europe
HORIZON.2 Global Challenges and European Industrial Competitiveness
HORIZON.2.1 Health
HORIZON.2.1.4 Infectious Diseases, including poverty-related and neglected diseases
HORIZON-HLTH-2021-DISEASE-04
HORIZON-HLTH-2021-DISEASE-04-03 Innovative approaches to enhance poverty-related diseases research in sub-Saharan Africa