Clinical Trial to Evaluate the Safety and Immunogenicity of the Vivaxin Vaccine for Malaria Cause… (NCT07172724) | Clinical Trial Compass
Not Yet RecruitingPhase 1
Clinical Trial to Evaluate the Safety and Immunogenicity of the Vivaxin Vaccine for Malaria Caused by Plasmodium Vivax."
Brazil48 participantsStarted 2025-09
Plain-language summary
Phase 1 clinical trial to evaluate the safety, reactogenicity, and immunogenicity of a malaria vaccine named Vivaxin against the protozoan Plamodium vivax in participants with no prior malaria infection
Who can participate
Age range
18 Years – 59 Years
Sex
ALL
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
. Non-pregnant women and men aged between 18 and 59 years;
. Willingness to participate in the study and undergo all study procedures, as demonstrated by signing the informed consent form (ICF);
. In good general health, as determined by medical examination;
. Women of childbearing potential must agree to use an acceptable\* contraceptive method for at least 30 days prior to the first vaccination and for at least 6 months following administration of the first dose of the investigational product, ensuring at least 3 months after the final vaccine dose have elapsed;
. Agreement not to donate blood during the course of study participation.
Exclusion criteria
. Prior history of malaria infection confirmed by serological testing;
. Prior history of malaria vaccination;
. Intention to travel to a malaria-endemic area during the study period;
. Pregnant or breastfeeding women, or those intending to become pregnant or breastfeed within the first 6 months of the study;
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
Safety and reactogenicity of adverse events (AE) in the first 14 days
Timeframe: Day 14 after each immunization
2
Safety and reactogenicity of EA in the first 28 days
Timeframe: Day 28 after each immunization
3
Safety and reactogenicity of serious AEs (SAEs) and AEs of special interest (AESI) throughout the study duration
Timeframe: through study completion, an average of 18 months
4
Dose selection
Timeframe: Day 28 after the third dose of the vaccine of all participants
. Evidence of clinically active disease, such as but not limited to: neurological, renal, cardiovascular, endocrine, pulmonary, hepatic, hematological, immunological, neoplastic, or infectious diseases;
. Use of concomitant medication for control of an underlying medical condition;
. Positive serological test for HBV, HCV, or HIV;
. Any condition that, in the opinion of the study investigator, could pose a risk to the participant or confound the study results, including clinically stable chronic conditions such as diabetes, hypertension, or neuralgias, among others;