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Topic:
Vaccine
Sponsor:
INSERM
Funder:
Bundesministerium für Bildung und Forschung, through Kreditanstalt für Wiederaufbau (Germany);
Inserm, and Institut National de Transfusion Sanguine (France) ; Irish Aid, Department of Foreign Affairs and Trade (Ireland).
PRIMVAC is a VAR2CSA-derived placental malaria vaccine candidate aiming to prevent serious clinical outcomes of Plasmodium falciparum infection during pregnancy. The objective of PRIMALVAC trial was to assess the safety and immunogenicity of PRIMVAC adjuvanted with Alhydrogel or glucopyranosyl lipid adjuvant in stable emulsion (GLA-SE) in French and Burkinabe women who were not pregnant.
PRIMALVAC was a first-in-human, randomised, double-blind, placebo-controlled, dose escalation trial was done in two staggered phases, a phase 1A trial in 18–35-year-old women who were malaria naive in a hospital in France and a subsequent phase 1B trial in women who were naturally exposed to P falciparum and nulligravid in the clinical site of a research centre in Burkina Faso.