PfSPZ Challenge in Healthy Malaria-Naïve Adults in the United States

Summary

This phase I trial of the replication-intact PfSPZ Challenge vaccine given under CQ cover will enroll 28 healthy volunteers to receive PfSPZ or placebo, as well as suppressive doses of chloroquine (CQ)on varying schedules. 10 weeks post 3rd immunization subjects will be subjected to controlled human malarial infection. The primary objective of this study is to evaluate the safety and tolerability of escalating doses of Sanaria PfSPZ Challenge administered by DVI on varying schedules to healthy malaria-naïve adults taking suppressive doses of CQ (PfSPZ-CVac).

Timeline

Start

2016-09-12

Primary completion

2018-01-22

Completion

2018-01-22

Publications

• Murphy SC, Deye GA, Sim BKL, Galbiati S, Kennedy JK, Cohen KW, Chakravarty S, Kc N, Abebe Y, James ER, Kublin JG, Hoffman SL, Richie TL, Jackson LA. PfSPZ-CVac efficacy against malaria increases from 0% to 75% when administered in the absence of erythrocyte stage parasitemia: A randomized, placebo-controlled trial with controlled human malaria infection. PLoS Pathog. 2021 May 28;17(5):e1009594. doi: 10.1371/journal.ppat.1009594. eCollection 2021 May.

Drugs

Indications