Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: INTERVENTIONAL
Official Title: A Randomized, Dose-escalation Phase I/IIa Trial With Controlled Human Malaria Infection to Evaluate Safety, Tolerability, Immunogenicity and Efficacy of an Investigational RNA-based Vaccine for P
Brief Summary:
This is a randomized, dose-escalation Phase I/IIa trial to evaluate safety, tolerability, immunogenicity and efficacy of an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in healthy malaria-naive adults.
The multi-antigen malaria vaccine (designated BNT165e) is a combination of three distinct RNAs, BNT165c and BNT165d (composed of BNT165d1 and BNT165d2), encoding P. falciparum antigens encapsulated in lipid nanoparticles (LNPs).
The BNT165c RNA encodes the full Plasmodium falciparum circumsporozoite protein (PfCSP).
The BNT165d1 and BNT165d2 RNAs both encode conserved, immunogenic segments of liver stage-expressed proteins.