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

NCT05978037 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 58

Last updated 2024-11-06

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

  • University of Oxford

    lead OTHER

Principal Investigators

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
45 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2023-08-18
Primary Completion
2026-01-10
Completion
2026-03-10

Countries

  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05978037 on ClinicalTrials.gov