Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in I… (NCT03503058) | Clinical Trial Compass
CompletedPhase 2
Safety, Tolerability, Immunogenicity and Protective Efficacy of PfSPZ Vaccine and PfSPZ-CVac in Indonesian Adults Against Naturally-Transmitted Malaria
Indonesia345 participantsStarted 2022-05-07
Plain-language 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.
Who can participate
Age range
18 Years – 55 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Primary Safety Endpoint - The Number of Adverse Events Occurring After Investigational Product (IP) Administration
Timeframe: PfSPZ Vaccine: 7 days after each vaccination (2 days for local solicited AEs); PfSPZ-CVac: 14 days after each administration; SAEs for both products: from day of immunization until end of study (20 months-immunizations started ~2 months after FSFV).
2
Primary Efficacy Endpoint - Number of Participants With First Clinical Pf Malaria Cases
Timeframe: First 24 weeks of deployment; the entire period of deployment (293 days, or approximately 42 weeks).