BIO-001
Research type
Research Study
Full title
An open label Phase I/IIa clinical trial to assess the safety, immunogenicity and efficacy of the malaria vaccine candidate RH5.2-virus-like particle (VLP) in Matrix-M™, and to compare the safety and immunogenicity of the malaria vaccine candidates RH5.2-VLP in Matrix-M™ and RH5.1 soluble protein in Matrix-M™ used in various regimens (BIO-001 / CVIA 099)
IRAS ID
1005729
Contact name
Angela Minassian
Contact email
Sponsor organisation
University of Oxford
Research summary
Malaria is a major public health problem. There were around 240 million cases of malaria and 627,000 deaths worldwide in 2020. There is a great need for a safe, effective malaria vaccine and the team at University of Oxford is trying to make vaccine(s) which can prevent serious illness and death.
This study is being done to assess an experimental malaria vaccine for its ability to prevent malaria illness. This is done using a ‘blood-stage challenge model’. This is when volunteers are infected with malaria parasites using malaria-infected red blood cells.The vaccines we are testing in this part of the study are called "RH5.1" and “RH5.2-VLP”. They will be given with an adjuvant called “Matrix-M” which is a substance that improves the body’s response to a vaccination. RH5.1 is a protein vaccine. It has been used in two previous trials and given to over 100 volunteers and has been shown to be safe and well tolerated in these trials. It has also been shown to make a good immune response and slow down the rate of malaria infection. RH5.2-VLP is being tested for the first time in humans in this trial. The Matrix-M adjuvant has been given to tens of thousands of people, with no major concerns, such as illness.
The aim is to use this vaccine and adjuvant to help the body make an immune response against parts of the malaria parasite. This study will assess:
1. The safety of the vaccine in healthy participants.
2. The response of the human immune system to the vaccine.
3. The ability of the vaccine to prevent malaria illness (Group 2 only).We will do this by giving healthy adult participants (aged 18-45) three of the vaccines and/or expose participants to malaria infection at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM), Churchill Hospital in Oxford. We will then do blood tests and collect information about any symptoms that occur after vaccination. There will be 19 to 54 visits, lasting between 3 months to 2 years and 2 months.
REC name
London - City & East Research Ethics Committee
REC reference
23/LO/0412
Date of REC Opinion
6 Jul 2023
REC opinion
Further Information Favourable Opinion