Vac096
Research type
Research Study
Full title
A phase 1 study to assess the safety and immunogenicity of R21/Matrix-MTM administered in an escalating dose, multi-prime vaccination schedule in healthy adults
IRAS ID
1008352
Contact name
Adrian Hill
Contact email
Sponsor organisation
University of Oxford
Research summary
Malaria is an infectious disease caused by a parasite which is spread by the bite of an infected mosquito. 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.
The purpose of this study is to evaluate an experimental malaria vaccine for its safety, and we will look at the body’s immune response to the vaccine. The vaccine we are testing is called “R21”, it will be given with an adjuvant called “Matrix-M”. An adjuvant is a substance to improve the body’s response to a vaccination.
The aim is to use the vaccine and adjuvant to help the body make an immune response against parts of the malaria parasite. R21 and Matrix-M have been shown to be safe and protect against malaria in previous studies. This study will assess a new dosing regimen for R21 and Matrix M where multiple, small, increasing doses of vaccine are given over two weeks. It is hoped this dosing regimen will lead to antibody levels which are higher and last for longer.
In this study we will assess;
1. The safety of R21/Matrix-M in healthy participants when administered in multiple, small, escalating doses.
2. The response of the human immune system to R21/Matrix-M when given in such an administration regimen.This study will involve healthy adult participants (aged 18-50) who will receive a minimum of two and a maximum of six doses of the vaccine.
We will collect blood samples and samples from the lymph nodes in the armpit close to the vaccination site in order to effect of the new dosing schedule on immune responses to vaccination.REC name
South Central - Oxford A Research Ethics Committee
REC reference
23/SC/0386
Date of REC Opinion
18 Jan 2024
REC opinion
Further Information Favourable Opinion