Vaccine Efficay and Placebo Cohorts with Malaria Natural History Groups 2 & 3: Safety, Immunogenicity, and Protective Efficacy of Radiation Attenuated Plasmodium falciparum NF54

Double-blind, randomized, placebo-controlled trial that started on 01 April 2016 to assess the safety, tolerability and protective efficacy of PfSPZ Vaccine against naturally occurring infection. The start of the study was dependent on the safety and tolerability results of the pilot study. The PfSPZ Vaccine targeted dose was 1.8x10^6 PfSPZ, or the highest tolerable dose determined from the Pilot Study (Arm 1c, 1d). Arm 2 (n=60) was the targeted vaccine dose arm and received 3 doses of PfSPZ Vaccine (1.8x106) via DVI on Days 1, 57, 113. Arm 3 (n=60) was the placebo-controlled arm and received 3 doses of normal saline (NS) via DVI on Days 1, 57, 113. All volunteers received antimalarial treatment prior to vaccination #1 and vaccination #3. All subjects were assessed by thick blood smear (TBS) every 2 weeks after the 3rd dose until week 24 and as indicated for symptoms.