drugset / Trial / NCT02600975

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

NCT02600975

Phase 1 Completed 20 enrolled University of Oxford
Non-randomizedParallel-groupOpen-labelPrevention

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.

Timeline

Start
2015-12-08
Primary completion
2017-01-19
Completion
2017-01-19

Drugs

EvaluationDrugModalityDoseRoute
Comparator R21 Vaccine 10 ug Intramuscular
Comparator R21 Vaccine 50 ug Intramuscular
Comparator ASO1B Unknown Intramuscular

Indications