BIO-002

• Research type

  Research Study

• Full title

  Phase I clinical trial to assess the safety and immunogenicity of the malaria vaccine candidate RH5.1 soluble protein in Matrix-MTM using two dosing regimens

• IRAS ID

  1005754

• Contact name

  Ruth Payne

• Contact email

  r.o.payne@sheffield.ac.uk

• Sponsor organisation

  University of Oxford

• ISRCTN Number

  ISRCTN95289709

• Research summary

  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 travellers. 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 we are testing in this study is called and “RH5.1”. This is given with an adjuvant called “Matrix-M”. This is a substance to improve the body’s response to a vaccination.
  The aim is to use the vaccines 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 vaccines in healthy participants.
  2. The response of the human immune system to the vaccines.

  We will do this by giving participants three doses of the RH5.1 vaccines at two different dose levels (10 micrograms and 50 micrograms). One group will have 3 doses of 10 micrograms given at 0, 1 and 6 months whilst the other will receive 2 doses of 50 micrograms (at 1 and 2 months) followed by a 10 microgram dose at 6 months- known as a 'delayed fractional dose'. We will then do blood tests and collect information about any symptoms that occur after vaccination.
  Information from previous studies suggests that a delayed fractional dose improves the immune response to the vaccine, particularly in terms of the antibody response. We suspect that this improvement is due to the delay in dosing, rather than the reduction in dose, and this study will help to answer that. Having a vaccine at a single dose is important for efficient production and dosing for vaccines rolled out in national programs so being able to move away from 'delayed fractional dose' regimens to 'delayed final dose' regimens will be important for vaccine development.

• REC name

  London - Chelsea Research Ethics Committee

• REC reference

  23/LO/0058

• Date of REC Opinion

  4 Apr 2023

• REC opinion

  Further Information Favourable Opinion