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ACTIVE NOT RECRUITING
NCT06320535
PHASE1

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

Sponsor: University of Oxford

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

18 Years - 50 Years

Study Type

INTERVENTIONAL

Enrollment

36

Start Date

2024-03-25

Completion Date

2027-06

Last Updated

2025-11-17

Healthy Volunteers

Yes

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.

Locations (2)

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

Oxford, Oxfordshire, United Kingdom

University Hospitals Bristol and Weston NHS Foundation Trust

Bristol, United Kingdom