CompletedPhase 1

A Study to Assess the Experimental Malaria Vaccines RH5.2-VLP and R21

The Gambia107 participantsStarted 2023-07-10

Plain-language summary

This is a Phase Ib multi-stage Plasmodium falciparum malaria vaccine study to assess the safety and immunogenicity of the blood-stage vaccine candidate RH5.2 virus-like particle (VLP) in Matrix-MTM and the pre-erythrocytic stage vaccine candidate R21 in Matrix-MTM, both alone and in combination, in adults and infants in the Gambia

Who can participate

Age range

5 Months – 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: * Groups 1, 2 and 6-9: Healthy male or female infants aged 5-17 months at the time of enrolment with signed consent obtained from parents or guardians. * Groups 3-5: Healthy male or female adults aged 18-45 years at the time of enrolment with signed consent. * Groups 3-5 (Female participants only): Must be non-pregnant (as demonstrated by a negative urine pregnancy test), and practice continuous effective contraception for the 24 to 30 month duration of the study (see section 9.9). * Planned long-term (at least 24 months from the date of recruitment) or permanent residence in the study area. * Adults with a Body Mass Index (BMI) 18 to 30 Kg/m2; or infants with Z-score of weight-for-age within ±2SD. Exclusion Criteria: * Clinically significant congenital abnormalities as judged by the PI or other delegated individual * Clinically significant history of skin disorder (psoriasis, contact dermatitis etc.), allergy, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease and neurological illness as judged by the PI or other delegated individual. * Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent, severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed). * History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in si…

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

To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing the occurrence of solicited local reactogenicity signs and symptoms via clinic and home visits

Timeframe: 7 days following each vaccination

To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing the occurrence of solicited systemic reactogenicity signs and symptoms via clinic and home visits

Timeframe: 7 days following each vaccination

To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing occurrence of unsolicited adverse events

Timeframe: 28 days following the vaccination

Safety of the RH5.2-VLP with Matrix-M and R21 with Matrix-M vaccine, assessed through the number of participants with abnormal laboratory test results

Timeframe: 28 days following the vaccination

Assessment of safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants assessed through the number of participants with serious adverse events

Timeframe: Whole duration of the study (24-30 months following initial trial vaccination)

Trial details

NCT IDNCT05357560

SponsorUniversity of Oxford

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-12-11

View on ClinicalTrials.gov More Malaria, Plasmodium Falciparum trials

Plain-language summary

Who can participate

Age range

5 Months – 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.

What they're measuring

Timeframe: 7 days following each vaccination

To determine safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants by assessing occurrence of unsolicited adverse events

Timeframe: 28 days following the vaccination

Safety of the RH5.2-VLP with Matrix-M and R21 with Matrix-M vaccine, assessed through the number of participants with abnormal laboratory test results

Timeframe: 28 days following the vaccination

Assessment of safety and tolerability of RH5.2-VLP with Matrix-M and R21 with Matrix-M, in healthy adults and infants assessed through the number of participants with serious adverse events

Timeframe: Whole duration of the study (24-30 months following initial trial vaccination)