NCT02572388

A Study to Assess the Safety and Immunogenicity of the Malaria Vaccine, R21, Administered With and Without Matrix-M1

Safety and Immunogenicity of a Protein Particle Malaria Vaccine Candidate, R21, Administered With and Without Matrix-M1 in Healthy UK Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

This is a clinical trial in which healthy volunteers will be administered one or two experimental malaria vaccines. The vaccine R21 will either be administered alone or in combination with the adjuvant vaccine Matrix-M1. All vaccinations will be administered intramuscularly. Each volunteer will receive three vaccinations in total. There are three different vaccine schedules: Group 1 will receive 10µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56. Group 2 will receive 50µg of R21 on days 0, 28, and 56. . Group 3 will receive 50µg of R21 mixed with 50µg of Matrix-M1 on days 0, 28, and 56. The study will assess the safety of the vaccines, and the immune responses to the vaccinations. Immune responses are measured by tests on blood samples. Healthy adult volunteers will be recruited in Oxford and London, England.

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	R21
BIOLOGICAL	Matrix-M1

Timeline

• Start date: 2015-10-15
• Primary completion: 2017-08-29
• Completion: 2017-08-29
• First posted: 2015-10-08
• Last updated: 2019-11-12
• Results posted: 2019-11-12

Locations

2 sites across 1 country: United Kingdom