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 range18 Years – 59 Years
SexALL
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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;
✕. 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;
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
✕. 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;