Last Updated: 02/12/2024
Safety and immunogenicity of Rh5.1/Matrix M in health adult volunteers in different doses
Objectives
The aim is to use vaccines and adjuvants to help the body make an immune response against parts of the malaria parasite. This study will assess the safety of the vaccines in healthy participants and the response of the human immune system to the vaccines.
Secondary objectives are:
1. To assess the humoral immunogenicity of RH5.1 soluble protein with Matrix-M when administered to healthy adult volunteers at different doses.
2. To compare the anti-RH5 serum IgG functional immunogenicity between the two dose regimens – assessment of serum anti-RH5 IgG quantity, functional quality, and longevity.
Malaria is a major public health problem. There were around 240 million cases of malaria and 627,000 deaths worldwide in 2020. Most of the deaths are in children under five living in Africa. It is a major problem for those who live in affected areas and for travelers. There is a great need for a safe, effective malaria vaccine. This study is being done to evaluate an experimental malaria vaccine for its safety. We will also look at the body’s immune response to the vaccine. The vaccine being tested in this study is called RH5.1. This is given with an adjuvant called “Matrix-M”. This is a substance to improve the body’s response to vaccination. Participants are given three doses of the RH5.1 vaccines at two different dose levels (10 and 50 micrograms; μg). One group will have three doses of 10 μg given at 0, 1, and 6 months whilst the other will receive two doses of 50 μg (at 1 and 2 months) followed by a 10 μg dose at 6 months – known as a ‘delayed fractional dose’. The researchers will then do blood tests and collect information about any symptoms that occur after vaccination.
Study type: Interventional
Enrollment: 24 participants
Primary purpose: Prevention
Allocation: Randomized
Interventional Model: Parallel assignment
Masking : Single
Trial number: ISRCTN95289709
Phase: Phase I
Jan 2023 — Jul 2024
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