BioNTech posts results for Phase I/IIa malaria RNA vaccine trial; CHMI portion skipped

This week's update centers on a single completed BioNTech malaria vaccine study.

• Trial: "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 Prevention of P. Falciparum Malaria in Healthy Malaria naïve Adults" (NCT06069544), sponsored by BioNTech SE. The study tested an investigational RNA-based vaccine (BNT165e) for prevention of P. falciparum malaria in healthy malaria-naive adults.¹ Status is completed, with results first posted 2026-08-28.
• The vaccine combines three RNA components: BNT165c and BNT165d (composed of BNT165d1 and BNT165d2), encoding P. falciparum antigens encapsulated in lipid nanoparticles, with BNT165c encoding the full circumsporozoite protein and BNT165d1/d2 encoding conserved liver stage-expressed protein segments.¹
• Enrollment reached 163 participants, up from the original plan, because the number of participants was increased to 163 due to participant replacement or re-enrollment.¹
• The initially planned Part B with a controlled human malaria infection model was not performed,¹ despite being named in the trial title.