NCT06320535View on ClinicalTrials.gov

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

PHASE1RecruitingINTERVENTIONAL
Enrollment

36

Participants

Timeline

Start Date

March 25, 2024

Primary Completion Date

June 30, 2026

Study Completion Date

June 30, 2027

Conditions
Malaria,Falciparum
Interventions
BIOLOGICAL

R21/Matrix M™ (Group 1)

"* 0.50 mcg R21 in 2.75 mcg Matrix-M™ (D0)~* 0.75 mcg R21 in 3.5 mcg Matrix-M™ (D3)~* 1.25 mcg R21 in 6.25 mcg Matrix-M™ (D7)~* 2.5 mcg R21 in 12.5 mcg Matrix-M™ (D10)~* 5 mcg R21 in 25 mcg Matrix-M™ (D14)~* 10 mcg R21 in 50 mcg Matrix-M™ (D56)"

BIOLOGICAL

R21/Matrix M™ (Group 2)

"* 0.50 mcg R21 in 2.75 mcg Matrix-M™ (D0)~* 0.75 mcg R21 in 3.5 mcg Matrix-M™ (D3)~* 1.25 mcg R21 in 6.25 mcg Matrix-M™ (D7)~* 2.5 mcg R21 in 12.5 mcg Matrix-M™ (D10)~* 5 mcg R21 in 25 mcg Matrix-M™ (D14)~* 10 mcg R21 in 50 mcg Matrix-M™(D168)"

BIOLOGICAL

R21/Matrix M™ (Group 3)

"* 10 mcg R21 in 50 mcg Matrix-M™ (D0)~* 10 mcg R21 in 50 mcg Matrix-M™ (D56)"

PROCEDURE

Fine needle aspiration (FNA)

Participants in all groups will undergo fine needle aspiration (FNA) of axillary lymph nodes draining vaccination site on Day 77 and Day 105 after initial vaccination.

Trial Locations (2)

OX3 7LE

RECRUITING

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

BS2 8HW

NOT_YET_RECRUITING

University Hospitals Bristol and Weston NHS Foundation Trust, Bristol

All Listed Sponsors
collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

University Hospitals Bristol and Weston NHS Foundation Trust

OTHER

lead

University of Oxford

OTHER