Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults (NCT06507605) | Clinical Trial Compass
CompletedPhase 1
Dose-Escalating Study of Pfs230D1 in Combination With R21 in Matrix-M in African Adults
Mali240 participantsStarted 2024-08-30
Plain-language summary
This is a Phase 1, individually randomized, double-blind, dose escalating study designed to evaluate the safety, tolerability, and immunogenicity of Pfs230D1 conjugate vaccines, R21 nanoparticle vaccine, or their combination conjugate vaccines, formulated on Matrix-M in healthy African adults aged 18 to 50 years.
Who can participate
Age range
18 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: 18 to 50 years old.
. Provides written informed consent.
. Able to understand and comply with planned study procedures and be available for the duration of the trial.
. In good general health and without clinically significant medical history in the opinion of the investigator.
. Females of childbearing potential must be willing to use reliable contraception from 21 days prior to Study Day 1 and until 1 month after the last vaccination.
Exclusion criteria
. Pregnant and breastfeeding females.
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
Timeframe: within 30-minutes following each dose
2
Number of Participants with Solicited local adverse events
Timeframe: for 7 days following each dose
3
Number of Participants with Solicited systemic adverse events
Timeframe: for 7 days following each dose
4
Number of Participants with Unsolicited adverse events
Timeframe: for 28 days following each dose
5
Number of Participants with Abnormal Laboratory Values post-vaccination
Timeframe: within 7 days following each dose
6
Number of Participants with Serious adverse events