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 range
9 Years – 50 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
. 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.
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
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
. 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.
. Evidence of clinically significant neurologic, cardiac, pulmonary, hepatic, endocrine, rheumatologic, autoimmune, hematological, oncologic, or renal disease by history, physical examination, and/or laboratory studies including urinalysis.
. Current or planned participation in an investigational product study until the time period of the last required study visit under this protocol.
. Medical, occupational, or family problems as a result of alcohol or illicit drug use during the past 12 months.
. History of a severe allergic reaction or anaphylaxis.