Last Updated: 27/10/2022
Safety and immunogenicity of a protein particle malaria vaccine candidate, R21, administered with and without Matrix-M1 in healthy UK volunteers.
Objectives
To assess the safety of the vaccines, and the immune responses to the vaccinations. Immune responses are measured by tests on blood samples.
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.
NCT number: NCT02572388
Study type: Interventional
Enrollment: 31 participants
Allocation: Non-Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Oct 2015 — Aug 2017
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