The EU has awarded a grant to the University of Copenhagen for the first clinical trials of a vaccine for malaria parasites that infect pregnant women.
Funding of the PlacMalVac project will enable clinical trials of the VAR2CSA vaccine and continue its development, including upstream and downstream process development.
The antigen for the vaccine was discovered in 2003 by Professor Ali Salanti and others at the University of Copenhagen.
It was developed to preclinical stage with the help of Professor Philippe Deloron at Institut de Recherche pour le Développement in France and ExpreS2ion Biotechnologies, who provided the protein antigen variants for selection of the best candidate.
The clinical development programme was initiated in 2012 with support from the Danish National Advanced Technology Foundation (DNATF).
Professor Ali Salanti from the University of Copenhagen said this initial funding from DNATF allowed the research team to commence "a very ambitious and high-risk vaccine development project" so that the team was able to show proof-of-concept of the malaria vaccine
"We are currently addressing manufacturability of the vaccine. The funding from EU FP7 will enable us to continue the development including upstream and downstream process development, GMP production, Phase Ia and Ib human clinical trials, as well as preparations for Phase II clinical trials," Salanti added.
The clinical trials will be conducted in co-ordination with an international consortium, including the Centre for Medical Parasitology (CMP) from University of Copenhagen, ExpreS2ion Biotechnologies, Institut de Recherche pour le Développement, European Vaccine Initiative, Université d’Abomey-Calavi and University of Tübingen.
The vaccine is intended for women who have acquired immunity against malaria during childhood, but nevertheless become susceptible to malaria again during their first pregnancies.
Parasites accumulate in the placenta, where a combination of altered blood flow and expression of chondroitin sulphate A (CSA) provides a new niche for parasites to sequester.
This can be a major health problem in areas south of the Sahara.
Those who develop the disease risk anemia, impaired fetal development, low birth weight or spontaneous abortion.
It has been estimated by the World Health Organisation that placental malaria (PM) is responsible for 20,000 maternal and 200,000 infant deaths annually.
Professor Thor G Theander from the University of Copenhagen said; "This will be the first clinical trial using the parasite antigens that cause severe disease syndromes. The vaccine attempts not to eliminate the infection but to eliminate the disease.
"At Centre for Medical Parasitology we are all thrilled to have this opportunity and it marks an intermediate highpoint of many years of committed research. If the vaccine is safe it will, however, require many years of continued international support before it can help pregnant women and their unborn children."
Image: The vaccine is intended for women who have acquired immunity against malaria during childhood, but nevertheless become susceptible to malaria again during their first pregnancies. Photo: Courtesy of Ben Earwicker.
