Last Updated: 27/10/2022
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
Objectives
To assess the safety of the vaccine, and the immune responses to the vaccination. Immune responses are measured by tests on blood samples.
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.
Healthy adult volunteers will be recruited in Oxford and Southampton, England.
NCT number: NCT02600975
Study type: Interventional
Enrollment: 20 participants
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Dec 2015 — Jan 2017
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