Safety and Efficacy of Sanaria's PfSPZ-CVac in Malian Adults

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)

Timeline

Start

2017-04-06

Primary completion

2018-06-22

Completion

2018-06-22

Publications

• Coulibaly D, Kone AK, Traore K, Niangaly A, Kouriba B, Arama C, Zeguime A, Dolo A, Lyke KE, Plowe CV, Abebe Y, Potter GE, Kennedy JK, Galbiati SM, Nomicos E, Deye GA, Richie TL, James ER, Kc N, Sim BKL, Hoffman SL, Doumbo OK, Thera MA, Laurens MB; DMID 15-0052 PfSPZ-CVac Study Team. PfSPZ-CVac malaria vaccine demonstrates safety among malaria-experienced adults: A randomized, controlled phase 1 trial. EClinicalMedicine. 2022 Jul 30;52:101579. doi: 10.1016/j.eclinm.2022.101579. eCollection 2022 Oct.

Drugs

Indications