Saving the Unborn Child from Malaria: Safety and Efficacy of PfSPZ Vaccine for Pregnant Women and Unborn Children

Malaria Research and Training Center, University of Science Techniques and Technologies of Bamako
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Malaria is a scourge among pregnant women in developing countries, causing maternal, perinatal and infant mortality. Current tools (i.e., drugs, bed nets) are losing efficacy and the search for new safe tools has been unsuccessful. Sanaria’s PfSPZ vaccine prevents malaria infection both in laboratory settings and in Africa. In this project, the vaccine will be tested as a tool to prevent infection during pregnancy and improve newborn outcomes. The team will determine the safety and protective effects of vaccination against the background of a pregnancy registry study that will enroll ~900 women each year at the same study site in Ouelessebougou, Mali. The team will vaccinate women before and during pregnancy, and follow them for safety and efficacy outcomes including the presence of malaria parasites throughout pregnancy and in their placenta at delivery. Newborns will be followed for 12 months to document development. If successful, this project could radically change malaria management for pregnant women in developing countries, and will significantly improve standard practice, which relies largely on mass administration of a drug that is losing efficacy. Further, no malaria vaccine has ever been tested on pregnant women, and no vaccine of any kind is FDA-approved to date for use in pregnancy. The collaborating groups in this proposal have the world’s leading programs to develop vaccines for malaria elimination and eradication, an ambitious and historic goal as pregnant women contribute disproportionately to the malaria reservoir because they are susceptible to infection and attractive to mosquitoes. PfSPZ offers an innovative approach to vaccinate pregnant women and women in their reproductive years and thereby include them in future malaria-elimination programs.

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