NCT05978037

A Study to Assess the Safety and Effectiveness of Two Experimental Malaria Vaccines

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-MTM, and to Compare the Safety and Immunogenicity of the Malaria Vaccine Candidates RH5.2-VLP in Matrix-MTM and RH5.1 Soluble Protein in Matrix-MTM Used in Various Regimens

• Status: Active Not Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 58 (estimated)
• Sponsor: University of Oxford · Academic / Other
• Sex: All
• Age: 18 Years – 45 Years
• Healthy volunteers: Accepted

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 vaccine we are testing in this part of the study is called "RH5.2-VLP". It is given with an adjuvant called "Matrix-M". This is a substance to improve the body's response to a vaccination. 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.

Conditions

• Malaria
• Malaria,Falciparum
• Parasitic Disease
• Vector Borne Diseases
• Infections

Interventions

Type	Name	Description
BIOLOGICAL	RH5.1 and/or RH5.2-VLP with Matrix-M	The RH5.1 protein consists of the entire full-length ectodomain of the PfRH5 antigen (amino acids E26 - Q526) with the sequence based on the 3D7 clone of P. falciparum. The RH5.2 protein consists of the "stabilised" core region of PfRH5 antigen with SpyTag fused at the C-terminus. The RH5.2-SpyTag protein is conjugated to hepatitis B surface antigen (HBsAg)-SpyCatcher to produce the final RH5.2-VLP vaccine. The Matrix-M has been developed and manufactured by Novavax AB and is presented as a liquid solution in a glass vial.

Timeline

• Start date: 2023-08-18
• Primary completion: 2026-01-10
• Completion: 2026-03-10
• First posted: 2023-08-07
• Last updated: 2024-11-06

Locations

1 site across 1 country: United Kingdom