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

NCT03503058 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 345

Last updated 2026-05-04

Study results available
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Summary

The study is a double-blind, randomized, placebo-controlled, Phase 2 clinical trial that will assess the safety, tolerability, immunogenicity and protective efficacy of PfSPZ Vaccine and PfSPZ-CVac against naturally occurring malaria in healthy Indonesian soldiers deployed to eastern Indonesia.

Conditions

Interventions

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.

OTHER

Normal Saline

0.9% Sodium chloride

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.

Sponsors & Collaborators

  • Oxford University Clinical Research Unit Indonesia

    collaborator OTHER

  • Indonesia University

    collaborator OTHER

  • Congressionally Directed Medical Research Programs

    collaborator FED

  • Sanaria Inc.

    lead INDUSTRY

Principal Investigators

  • Kevin Baird, Ph.D. · Eijkman-Oxford Clinical Research Unit, Eijkman Institute of Molecular Biology, Indonesia

  • Erni J Nelwan, MD, Ph.D. · Department of Internal Medicine, Universitas Indonesia

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
55 Years
Sex
MALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-05-07
Primary Completion
2024-02-27
Completion
2024-02-27
FDA Drug
Yes

Countries

  • Indonesia

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03503058 on ClinicalTrials.gov