Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria

Summary

Participation Requirements

Description

The study is a single site, double-blind, randomized, placebo-controlled clinical trial that will assess the safety, tolerability, immunogenicity and vaccine efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally occurring malaria in Indonesian soldiers. A total of 420 participants will be rando...

The study is a single site, double-blind, randomized, placebo-controlled clinical trial that will assess the safety, tolerability, immunogenicity and vaccine efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally occurring malaria in Indonesian soldiers. A total of 420 participants will be randomized 1.0:0.5:1.0:0.5 to 4 groups. Participants will be recruited from an Indonesian army battalion based in a malaria-free area. All volunteers will be healthy males aged 18 to 55 years. They will be immunized in a malaria-free area of Indonesia, and then deployed to eastern Indonesia for ~6-9 months. Standard safety, tolerability, and parasitology data will be collected before deployment during the immunization period. Participants will receive three doses by DVI of PfSPZ Vaccine on days 1, 8, and 29, PfSPZ Challenge with chloroquine (CQ) prophylaxis on days 1, 29, and 57, normal saline (NS) on days 1, 8, and 29, or normal saline with CQ prophylaxis on days 1, 29, and 57. The PfSPZ Vaccine dose will be 9 x 10^5 PfSPZ. The PfSPZ Challenge dose will be 2 x 10^5 PfSPZ. CQ will first be given as a loading dose of 620 mg base two days before the first administration of PfSPZ Challenge or NS, followed by weekly 310 mg doses of CQ with the last dose 5 days after the last dose of PfSPZ Challenge.

Tracking Information