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A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™
Sponsor: University of Oxford
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
Conditions
Interventions
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)
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)
R21/Matrix M™ (Group 3)
* 10 mcg R21 in 50 mcg Matrix-M™ (D0) * 10 mcg R21 in 50 mcg Matrix-M™ (D56)
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