Safety and Efficacy of Sanaria's PfSPZ-CVac in Malian Adults
Status:
Completed
Trial end date:
2018-06-22
Target enrollment:
Participant gender:
Summary
Single site, double-blinded, randomized, placebo-controlled clinical trial of PfSPZ-CVac
safety, tolerability, immunogenicity and efficacy against naturally occurring malaria in
malaria-exposed Malian adults. The overall goal of the study is to evaluate if a regimen of
PfSPZ-CVac (PfSPZ Challenge under chemoprophylaxis) is safe, well-tolerated, and provides
sterile protection against naturally-occurring malaria in malaria-experienced adults. The
study population includes 62 healthy, malaria-experienced adults aged 18-45 years, inclusive,
residing in Bougoula Hameau and surrounding villages, Mali. The primary objective of this
study is to assess the safety and tolerability of PfSPZ Challenge compared to placebo among
malaria-experienced adults taking chloroquine prophylaxis (PfSPZ-CVac)
Phase:
Phase 1
Details
Lead Sponsor:
National Institute of Allergy and Infectious Diseases (NIAID)