A Clinical Trial to Evaluate the Safety, Efficacy and Immune Responses After Vaccination With an Investigational RNA-based Vaccine Against Malaria - Trial NCT06069544

Timeline & Enrollment

Primary Outcome

Frequency of solicited local reactions at the injection site (pain, erythema/redness, induration/swelling) recorded up to 7 days after each dose,Frequency of solicited systemic reactions (vomiting, diarrhea, headache, fatigue, muscle/joint pain, and fever) recorded up to 7 d after each dose,Frequency of participants with at least one adverse event (AE) occurring until 28 days after each dose,Frequency of participants with at least one medically attended adverse event (MAAE) occurring until 24 weeks after Dose 3,Frequency of participants in each cohort with at least one serious adverse event (SAE) occurring until 24 weeks after Dose 3

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.

ICD-10 Classifications