Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults (NCT07147400) | Clinical Trial Compass
RecruitingPhase 2
Pfs230D1 + R21 in Matrix-M1 in African School Children and Adults
Mali1,200 participantsStarted 2025-08-22
Plain-language summary
This is a Phase 2, randomized, double-blind, controlled study designed to evaluate the safety, tolerability, immunogenicity, vaccine efficacy, and functional activity of Pfs230D1-CRM197 conjugate vaccine with R21 nanoparticle vaccine formulated on Matrix-M1. Participants (9-50 years of age) will be drawn from Bancoumana, Mali and the surrounding areas.
Who can participate
Age range9 Years – 50 Years
SexALL
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Inclusion criteria
✓. Age:\>/= 9 years old and \</= 50 years old.
✓. Provides written informed consent if \>/=18 years of age.
✓. Provides written informed consent of parent/guardian if \<18 years of age, with additional participant written assent obtained from children \> 12 years of age.
✓. Known resident or long-term resident (more than 1 year) of trial site or surrounding villages.
✓. Available for the duration of the trial.
✓. Able to provide proof of identity to the satisfaction of the study clinician completing the enrollment process.
✓. In good general health and without clinically significant medical history in the opinion of the investigator.
✓. Permission for long term storage of blood samples.
Exclusion criteria
✕. Pregnant and breastfeeding females. Pregnant, as determined by a positive urine or serum beta human choriogonadotropin (βhCG) test.
✕. Menstruating females less than 12 years of age. (In order to avoid cultural implications of further assessing pregnancy potential i.e. sexual activity in this age group).
✕. Behavioral, cognitive, or psychiatric disease that in the opinion of the investigator affects the ability of the participant to understand and comply with the study protocol at a level appropriate for the participant's age.
What they're measuring
1
Number of Participants with Immediate adverse events in all participants
Timeframe: Up to 30-minutes following each dose
2
Number of Participants with solicited local adverse events in reactogenicity group
Timeframe: Up to 7 days following each dose
3
Number of Participants with Solicited systemic adverse events in reactogenicity group
Timeframe: Up to 7 days following each dose
4
Number of Participants with Unsolicited adverse events in all participants
Timeframe: Up to 28 days following each vaccination
5
Number of Participants with Serious adverse events in all participants
Timeframe: Through the whole study duration, 24 months post dose 3 or 12 months post dose 4
6
Number of Participants with Abnormal Laboratory Values post-vaccination in laboratory safety group