Safety, Tolerability, and Immunogenicity of Plasmodium falciparum Sporozoite Vaccine Administered by Direct Venous Inoculation to Infants and Young Children

KSPZV1 Part 2 is a single center, randomized, double-blind, placebo-controlled trial enrolling 336 malaria-exposed Kenyan children ages 5 to 12 months at the time of first vaccination. Subjects were randomized to 1 of 4 groups in a 1:1:1:1 ratio to receive 3 doses at 8-week intervals of either 4.5 x10^5, 9.0 x10^5, or 1.8 x10^6 PfSPZ or normal saline as a control.