Phase
Condition
N/ATreatment
R21/Matrix M™ (Group 2)
R21/Matrix M™ (Group 3)
Fine needle aspiration (FNA)
Clinical Study ID
Ages 18-50 All Genders Accepts Healthy Volunteers
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Healthy adult aged 18 to 50 years.
Able and willing (in the Investigator's opinion) to comply with all studyrequirements.
Participants of childbearing potential only: must practice continuous effectivecontraception 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
Exclusion Criteria:
History of clinical malaria (any species) or previous participation in any malariavaccine trial or controlled human malaria infection trial.
Travel to a clearly malaria endemic locality during the study period or within thepreceding 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 investigationalmedicinal product (IMP) in the 30 days preceding enrolment or 5 half-lives of theinvestigational medicinal product, whichever is longer, or planned participationduring the study period.
Prior receipt of an IMP likely to impact interpretation of the trial data, asassessed by the Investigator.
Receipt of any vaccine within 30 days of a study vaccine, with the exception ofCOVID-19 vaccination.
Receipt of oral or systemic immunosuppressant medication for more than 14 days inthe six months preceding enrolment.
Receipt of immunoglobulins or blood products (e.g. blood transfusion) in the threemonths preceding enrolment.
History of anaphylaxis to vaccination, or allergy likely to be exacerbated by anycomponent 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 basalcell carcinoma or cervical carcinoma in situ), immunodeficiency (including HIV),autoimmune conditions (except mild psoriasis, well-controlled autoimmune thyroiddisease, vitiligo or stable coeliac disease), psychiatric disorder, drug or alcoholabuse
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 concernregarding 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 weightheparin
Any clinically significant abnormality of screening examination, blood or urinetests
Any other significant disease, disorder, or finding, which, in the opinion of theInvestigator, may put the volunteer at risk, affect the volunteer's ability toparticipate in the study or impair interpretation of the study data
Participants unable to be closely followed for social, geographic or psychologicalreasons.
Investigator inability to corroborate a participant's medical history via access toNHS electronic records and/or their GP.
Study Design
Study Description
Connect with a study center
Centre for Clinical Vaccinology and Tropical Meducine, Churchill Hospital, University of Oxford
Oxford, Oxfordshire OX3 7LE
United KingdomActive - Recruiting
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, BS2 8HW
United KingdomSite Not Available
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