NCT06320535

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

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

• Status: Active Not Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 36 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Malaria,Falciparum

Interventions

Type	Name	Description
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)	Group 2A: * 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) Group 2B: * 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™(D280)
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.

Timeline

• Start date: 2024-03-25
• Primary completion: 2026-06-01
• Completion: 2027-06-01
• First posted: 2024-03-20
• Last updated: 2026-04-13

Locations

2 sites across 1 country: United Kingdom