Dataset from Phase 1, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Safety and Immunogenicity of Direct Venous Inoculation of a Radiation-attenuated Plasmodium Falciparum Sporozoite Vaccine (PfSPZ Vaccine) in Equatoguinean Adults

This is a single center, randomized, placebo-controlled, double-blind trial to assess the
safety and immunogenicity of PfSPZ Vaccine administered by direct venous inoculation (DVI).

The study to be conducted in Baney District, Bioko Island, Equatorial Guinea (EG), will be to
establish whether three doses of the higher regimen - three doses of 2.7x10^5 PfSPZ of the
PfSPZ Vaccine administered at 8 week intervals - is as well-tolerated and efficacious in
malaria exposed African adults as the five dose regimens. Specifically, the trial will
address the following objectives: is the three dose regimen:

1. Safe and well tolerated in Equatoguinean (EG) adults.

2. As immunogenic in EG adults as is the five-dose regimen of 1.35x10^5 PfSPZ in Tanzanian
and U.S. adults or as three-, four- and five-dose regimens of 2.7x10^5 PfSPZ being
tested in Tanzanian, Malian and U.S. adults.

In addition, as an exploratory objective, the volunteers in the EG trial will be followed
longitudinally to measure the incidence of malaria during the initial six months following
immunization, providing a preliminary assessment of efficacy.