Assessing a new malaria vaccine in healthy adults

A Phase 1 Study to Assess the Safety and Immunogenicity of R21/Matrix-M™ Administered in an Escalating Dose, Multi-prime Vaccination Schedule in Healthy Adults

This study is testing a new malaria vaccine in healthy adults to see if it is safe and how well it helps their immune system fight off malaria.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (estimated)
• Ages: 18 Years to 50 Years
• Sex: All
• Sponsor: University of Oxford (Academic / other)
• Locations: 2 sites (Oxford, Oxfordshire and 1 other locations)
• Trial ID: NCT06320535 on ClinicalTrials.gov

What this trial studies

This phase I clinical study evaluates the safety and immune response of a novel escalating dose regimen of the R21/Matrix-M™ malaria vaccine in healthy, malaria-naïve adults. Participants will receive either six escalating doses or two standard doses of the vaccine, with follow-up lasting 12-24 months. The study includes blood sampling and fine needle aspiration of lymph nodes to further characterize immune responses. Up to 36 volunteers will be enrolled to assess the vaccine's potential effectiveness.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 18 to 50 who have never had malaria and are willing to comply with study requirements.

Not a fit: Patients with a history of clinical malaria or previous participation in malaria vaccine trials will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a more effective malaria vaccine, improving prevention strategies against malaria.

How similar studies have performed: Other studies have shown promise with malaria vaccines, but this specific approach is novel and untested.

Eligibility criteria

Inclusion Criteria:

* Healthy adult aged 18 to 50 years.
* Able and willing (in the Investigator's opinion) to comply with all study requirements.
* Participants of childbearing potential only: must practice continuous effective contraception until the last study visit.
* 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) or previous participation in any malaria vaccine trial or controlled human malaria infection trial.
* Travel to a clearly malaria endemic locality during the study period or within the preceding six months, as per the CDC website: https://www.cdc.gov/malaria/travelers/country_table/a.html
* Participation in another research study involving receipt of an investigational medicinal product (IMP) in the 30 days preceding enrolment or 5 half-lives of the investigational medicinal product, whichever is longer, or planned participation during the study period.
* Prior receipt of an IMP likely to impact interpretation of the trial data, as assessed by the Investigator.
* Receipt of any vaccine within 30 days of a study vaccine, with the exception of COVID-19 vaccination.
* Receipt of oral or systemic immunosuppressant medication for more than 14 days in the six months preceding enrolment.
* Receipt of immunoglobulins or blood products (e.g. blood transfusion) in the three months preceding enrolment.
* History of anaphylaxis to vaccination, or allergy likely to be exacerbated by any component of the vaccine or study procedures, including allergy to lidocaine
* Pregnancy, lactation or intention to become pregnant during the study.
* Clinically significant history of chronic disease, including cancer (except basal cell carcinoma or cervical carcinoma in situ), immunodeficiency (including HIV), autoimmune conditions (except mild psoriasis, well-controlled autoimmune thyroid disease, vitiligo or stable coeliac disease), psychiatric disorder, drug or alcohol abuse
* Positive Hepatitis B surface antigen (HBsAg), HIV antibodies or Hepatitis C (HCV) antibodies (except previous HCV vaccine study participants)
* HEMStop score \> or = to 2(30) with abnormal coagulation screen or clinical concern regarding bleeding risk.
* Use of medications that increase the risk of bleeding, as assessed by the clinician, including: warfarin, oral antithrombin agents (e.g. Apixaban), low molecular weight heparin
* Any clinically significant abnormality of screening examination, blood or urine tests
* Any other significant disease, disorder, or finding, which, in the opinion of the Investigator, may put the volunteer at risk, affect the volunteer's ability to participate in the study or impair interpretation of the study data
* Participants unable to be closely followed for social, geographic or psychological reasons.
* Investigator inability to corroborate a participant's medical history via access to NHS electronic records and/or their GP.

Where this trial is running

Oxford, Oxfordshire and 1 other locations

• Centre for Clinical Vaccinology and Tropical Meducine, Churchill Hospital, University of Oxford — Oxford, Oxfordshire, United Kingdom (Recruiting)
• University Hospitals Bristol and Weston NHS Foundation Trust — Bristol, United Kingdom (Not_yet_recruiting)

Study contacts

• Principal investigator: Susanne Hodgson, DPhil FRCP — Center for Clinical Vaccinology and Tropical Medicine, University of Oxford
• Study coordinator: Volunteer Co-ordinators

Conditions Malaria,Falciparum