A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™

Last updated: October 14, 2024
Sponsor: University of Oxford
Overall Status: Active - Recruiting

Phase

1

Condition

N/A

Treatment

R21/Matrix M™ (Group 2)

R21/Matrix M™ (Group 3)

Fine needle aspiration (FNA)

Clinical Study ID

NCT06320535
VAC096
  • Ages 18-50
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

This is a phase I clinical study that aims to assess the safety and immunogenicity of a novel, escalating dose regimen of R21/Matrix-M™ in healthy, malaria-naïve adults.

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

Total Participants: 36
Treatment Group(s): 4
Primary Treatment: R21/Matrix M™ (Group 2)
Phase: 1
Study Start date:
March 25, 2024
Estimated Completion Date:
June 30, 2027

Study Description

This is a study to assess safety and immunogenicity of a novel dosing regimen for R21/ Matrix-M™, a leading Plasmodium falciparum malaria vaccine, in healthy, malaria-naïve adults. Participants in the study will receive either 6 escalating doses (groups 1 and 2) or 2 standard doses (group 3) of R21/ Matrix-M™, all delivered in the same arm. Up to 36 volunteers will be enrolled and followed up for 12-24 months after their first vaccine.

In addition to blood sampling throughout the follow-up period, participants will undergo fine needle aspiration of axillary lymph nodes twice during the study, to allow further characterisation of immune responses to this novel vaccine regimen.

Connect with a study center

  • Centre for Clinical Vaccinology and Tropical Meducine, Churchill Hospital, University of Oxford

    Oxford, Oxfordshire OX3 7LE
    United Kingdom

    Active - Recruiting

  • University Hospitals Bristol and Weston NHS Foundation Trust

    Bristol, BS2 8HW
    United Kingdom

    Site Not Available

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