345
Participants
Start Date
May 7, 2022
Primary Completion Date
February 27, 2024
Study Completion Date
May 29, 2024
PfSPZ Vaccine
Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine)
PfSPZ Challenge under chloroquine (CQ) chemoprophylaxis
"Infectious, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Challenge) administered under CQ chemoprophylaxis~Loading Dose: 10 mg/kg of CQ base (will be orally administered as a single loading dose to the participant by the study staff via directly observed therapy on PfSPZ-CVac Day -2.~Weekly Dose: Subsequent doses of maintenance dose CQ (5 mg/kg CQ base) will be given weekly as a single dose, with the last dose 5 days after the last dose of PfSPZ Challenge."
Normal Saline
0.9% Sodium chloride
Chloroquine chemoprophylaxis alone
"Loading Dose: 10 mg/kg of CQ base (will be orally administered as a single loading dose to the participant by the study staff via directly observed therapy on NS Day -2.~Weekly Dose: Subsequent doses of maintenance dose CQ (5 mg/kg CQ base) will be given weekly as a single dose, with the last dose 5 days after the last dose of NS."
Department of Internal Medicine, Universitas Indonesia, Jakarta
Eijkman-Oxford Clinical Research Unit, Eijkman Institute of Molecular Biology, Jakarta
Oxford University Clinical Research Unit Indonesia
OTHER
Indonesia University
OTHER
Congressionally Directed Medical Research Programs
FED
Sanaria Inc.
INDUSTRY