NCT02600975

A Study to Assess the Safety and Immunogenicity of a Malaria Vaccine Candidate, R21, Administered With AS01B

A Phase I Study to Assess the Safety and Immunogenicity of a Protein Particle Malaria Vaccine Candidate, R21, Administered With AS01B in Healthy UK Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 20 (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 an experimental malaria vaccine, R21. The R21 vaccine will be administered with the adjuvant AS01B. All vaccinations will be administered intramuscularly. Each volunteer will receive three vaccinations in total. There are two different vaccine schedules: Group 1 will receive R21 10µg with AS01B on days 0, 28, and 56. Group 2 will receive R21 50µg with AS01B on days 0, 28, and 56. The study will assess the safety of the vaccine, and the immune responses to the vaccination. Immune responses are measured by tests on blood samples. Healthy adult volunteers will be recruited in Oxford and Southampton, England.

Conditions

• Malaria

Interventions

Type	Name	Description
BIOLOGICAL	R21 with ASO1B	R21 with ASO1B

Timeline

• Start date: 2015-12-08
• Primary completion: 2017-01-19
• Completion: 2017-01-19
• First posted: 2015-11-09
• Last updated: 2017-06-20

Locations

2 sites across 1 country: United Kingdom