New malaria vaccines show promise in protecting indonesian soldiers
NCT ID NCT03503058
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tested two experimental malaria vaccines in 345 healthy Indonesian soldiers deployed to a malaria-endemic region. One vaccine uses weakened malaria parasites, and the other uses live parasites with a preventive drug. The goal was to see if either vaccine could safely prevent natural malaria infection. Results will help determine if these vaccines can protect people in high-risk areas.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Two malaria vaccines: PfSPZ Vaccine (weakened malaria parasites) and PfSPZ-CVac (live malaria parasites given with chloroquine to prevent infection)
- What this could lead to
- If successful, this could lead to an effective vaccine that protects people living in or traveling to malaria-endemic areas from getting sick.
- What could go wrong
- This is a phase 2 trial with 345 participants, so results may not apply to larger populations. The vaccines may not provide strong or lasting protection, and side effects like fever or injection site reactions are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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345 people
The number who actually took part.
- Started
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May 2022
- Finished
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Feb 2024
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 55 years
- Sex
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Male participants only
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * A male aged 18-55 years at the time of screening. * Assigned to the battalion of study and programmed to accompany it to eastern Indonesia for the duration of the deployment. * Freely provides written informed consent to participate in the study. * Agrees to adhere to Indonesian military medical guidance regarding screening and treatment of malaria. * Physical examination and laboratory results without clinically significant findings that would jeopardize the safety of the participant or the integrity of the study, and a body mass index (BMI) ≤35 kg/m\^2. Exclusion Criteria: * Previous vaccination with an investigational malaria vaccine. * Use of an investigational or non-registered drug or vaccine other than the study vaccine(s) within 30 days before the first study vaccination, or planned use up to 30 days after last vaccination. * Chronic administration (defined as more than 14 days) of immunosuppressant or other immune-modifying drugs within six months before the first vaccination. This includes any dose level of oral steroids, but not inhaled steroids or topical steroids. * Administration or planned administration of 1 live or 3 or more other type vaccines in the period beginning 28 days before the first study vaccination and ending 28 days after the last vaccination. * Confirmed or suspected immunosuppressive or immunodeficient condition. * Confirmed or suspected autoimmune disease. * History of allergic reactions or anaphylaxis to CQ or other 4-aminoquinolone derivatives. * History of serious allergic reactions to a drug (anaphylaxis, or requiring hospitalization). * History of allergy to phosphate buffered saline or human serum albumin. * Use or planned use of any drug with anti-malarial activity during the course of the study except for antimalarial medication administered by study clinicians. * History of splenectomy. * Laboratory evidence of liver disease (the final decision will be made by the PI and clinical officers, but in general a volunteer will be excluded if any of the screening liver function tests (ALT, bilirubin, gamma GTP) are \> double the upper limit of normal measured twice without an explanation for the abnormal values). * Laboratory evidence of renal disease (serum creatinine \> 1.5 mg/dL. measured twice). * Laboratory evidence of hematologic disease (platelet count or hemoglobin \<80% of the lower limit of normal for Indonesia measured twice). * Abnormal screening ECG showing prolonged QTc interval (\>450 msec) or any signs of arrythmia/irregularity, ischemia, cardiac enlargement considered considered indicative of acute or chronic cardiovascular disease. * Acute or chronic pulmonary, cardiovascular, hepatic, renal or neurological condition, severe malnutrition, or any other clinical findings that may increase the risk of participating in the study as determined by the principal investigator or her designee. * Administration of immunoglobulin and/or any blood products within the three months preceding the first study vaccination or planned administration during the study period. * Simultaneous participation in any other interventional clinical trial. * Other conditions that in the opinion of the principal investigator or her designee would jeopardize the safety or rights of a participant in the trial or would render the participant unable to comply with the protocol or might compromise the integrity of the data. * Any evidence of active malaria, whether symptomatic or asymptomatic, confirmed by RDT, microscopy or PCR before first injection of PfSPZ Vaccine or PfSPZ-CVac, unless treated by the clinical team. * History of non-febrile seizures or atypical febrile seizures. * Under treatment for tuberculosis. * Laboratory evidence of active infection with hepatitis B, or hepatitis C. * Subjects with \> 10% 5-year cardiovascular risk (fatal and non-fatal) based on the Gaziano scoring system; subjects in the 18-34 year old age group will be assessed as though they are in the 35-44 age group. * History of psychiatric disorders (such as personality disorders, anxiety disorders, or schizophrenia) or behavioral tendencies (including active alcohol or drug abuse) discovered during the screening process that in the opinion of the investigator would make compliance with the protocol difficult.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Department of Internal Medicine, Universitas Indonesia
Jakarta, 10430, Indonesia
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Eijkman-Oxford Clinical Research Unit, Eijkman Institute of Molecular Biology
Jakarta, 10430, Indonesia
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