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

PHASE2CompletedINTERVENTIONAL
Enrollment

345

Participants

Timeline

Start Date

May 7, 2022

Primary Completion Date

February 27, 2024

Study Completion Date

May 29, 2024

Conditions
Malaria
Interventions
BIOLOGICAL

PfSPZ Vaccine

Radiation-attenuated, aseptic, purified, cryopreserved Plasmodium falciparum sporozoites (PfSPZ Vaccine)

BIOLOGICAL

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."

OTHER

Normal Saline

0.9% Sodium chloride

DRUG

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."

Trial Locations (2)

10430

Department of Internal Medicine, Universitas Indonesia, Jakarta

Eijkman-Oxford Clinical Research Unit, Eijkman Institute of Molecular Biology, Jakarta

All Listed Sponsors
collaborator

Oxford University Clinical Research Unit Indonesia

OTHER

collaborator

Indonesia University

OTHER

collaborator

Congressionally Directed Medical Research Programs

FED

lead

Sanaria Inc.

INDUSTRY