Safety and Immunogenicity of Pvs25-IMX313/Matrix-M1 Vaccine (NCT05270265) | Clinical Trial Compass
TerminatedEarly Phase 1
Safety and Immunogenicity of Pvs25-IMX313/Matrix-M1 Vaccine
Stopped: The study was terminated due to administrative delays in the approval of a substantial amendment to extend the shelf-life of Pvs25-IMX313. Regulatory approval was only received on 11 August 2023, after end of study visits had already been conducted.
United Kingdom25 participantsStarted 2022-02-09
Plain-language summary
This is an open-label, single-centre, non-randomised, first-in-human Phase Ia study to assess the safety and immunogenicity of the Pvs25-IMX313 vaccine, administered in Matrix-M1 adjuvant.
Who can participate
Age range
18 Years – 45 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:
* Healthy adult aged 18 to 45 years.
* Able and willing (in the Investigator's opinion) to comply with all study requirements.
* Willing to allow the Investigators to discuss the volunteer's medical history with their GP.
* Volunteers with the potential to become pregnant only: must practice continuous effective contraception for the duration of the study. Acceptable forms of contraception for volunteers of child-bearing potential are: Established use of oral, injected or implanted hormonal methods of contraception, Placement of an intrauterine device or intrauterine system, Male sterilization (if the vasectomised partner is the sole partner for the participant), True abstinence from sex with sperm-producing partners, when this is in line with the preferred and usual lifestyle of the participant (periodic abstinence and withdrawal are not acceptable methods of contraception).
* Agreement to refrain from blood donation for the duration of the study.
* Able and willing to provide written informed consent to participate in the trial.
Exclusion Criteria:
* History of clinical malaria (any species).
* Travel to a clearly malaria endemic locality during the study period or within the preceding six months.
* Use of immunoglobulins or blood products (e.g., blood transfusion) in the last three months.
* Receipt of any vaccine in the 30 days preceding enrolment, or planned receipt of any other vaccine within 30 days following each study vaccination, with the exce…
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 Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Local Reactogenicity Signs and Symptoms
Timeframe: 7 days following each vaccination
2
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Participants Reporting Solicited Systemic Reactogenicity Signs and Symptoms.
Timeframe: 7 days following each vaccination
3
Safety and Tolerability of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Unsolicited Adverse Events.
Timeframe: 28 days following each vaccination
4
Safety of the Pvs25-IMX313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Occurrence of Abnormal Laboratory Test Results
Timeframe: 28 days following vaccination
5
Safety and Tolerability of the Pvs25-IMx313/Matrix-M1 Vaccine in Healthy Adult Volunteers: Number of Serious Adverse Events
Timeframe: Whole duration of the study period (8 months following enrolment)