Active not recruitingEARLY_PHASE1INTERVENTIONAL

A Phase Ia Clinical Trial to Assess the Safety and Immunogenicity of the Blood-stage Malaria Candidate Vaccines RH5.1 in Matrix-M and R78C in Matrix-M in Healthy UK Adults

This research is looking at new potential vaccines to stop people from getting malaria, specifically a type caused by *Plasmodium falciparum*. The study is happening in healthy adults in the UK and focuses on two experimental vaccine components, R78C and RH5.1, mixed with a booster called Matrix-M. It's an early phase trial to understand a few key things: how safe these new shots are, how well they help your body build protection against malaria, and if they might actually prevent the disease. By taking part, volunteers help scientists learn more about new ways to fight malaria worldwide.

At a glance

Status

Active not recruiting

Phase

EARLY_PHASE1

Sponsor

University of Oxford

Enrolment target

Start

13 Jan 2023

Estimated completion

31 Mar 2026

Malaria, Falciparum

What is this study about?

Malaria is a serious disease spread by mosquitoes, and it can make people very sick. While there are some ways to prevent malaria, scientists are always looking for better and more effective treatments and vaccines. This study is an important step in that journey. It focuses on two new experimental components, called R78C and RH5.1, which are designed to help your body create a defense against the malaria parasite. These components are combined with a 'booster' called Matrix-M, which helps the vaccine work better.

This research is a very early stage of testing, often called a Phase 1 trial. This means the main goals are to check if the new shots are safe for people and if they encourage your body to produce an immune response – that is, if your body starts to build protection against malaria. Researchers will also look at whether the shots can protect against malaria itself. By carefully studying these new vaccine components in healthy volunteers, scientists can gather crucial information that will help decide if they are promising enough to be tested in larger groups of people in the future.

Taking part in this kind of study helps improve our understanding of malaria and how to fight it. Finding new ways to protect people from malaria could save many lives and reduce illness, especially in parts of the world where malaria is common. Every step, even these early ones, brings us closer to better tools for global health.

Key takeaways

Tests new malaria vaccine components in healthy adults.
Aims to check vaccine safety and body's immune response.
Participation involves injections and clinic visits over 12-20 months.
Helps develop new ways to fight malaria worldwide.
Study location is Oxford, UK.

Who may be eligible?

To join this study, you need to be a healthy adult between 18 and 45 years old. You should also be willing and able to follow all the study instructions and allow the researchers to talk to your GP about your health history. If you are a woman who could become pregnant, you'll need to use reliable birth control during the study and for three months after your last vaccination.

There are several reasons why someone might not be able to join. For example, if you've ever had malaria, participated in a malaria vaccine study before, or if you've recently traveled to a country where malaria is common. You also can't join if you've received certain blood products or other vaccines recently, or if you're taking part in another clinical trial at the same time. People with a weakened immune system or certain serious health conditions are also not able to participate.

Quick self-check

Are you between 18 and 45 years old?
Have you *never* had malaria before?
Have you *not* traveled to a malaria-risk area in the last 6 months?
Are you willing to share your medical history with your GP?
If you are a woman who could get pregnant, are you able to use reliable birth control throughout the study?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you'll join one of four groups, with around 8 or 9 people in each. You'll receive one or two injections (shots) into the muscle of your upper arm (shoulder area). These shots will contain the experimental vaccine components and a booster. Your total participation will last for about 12 to 20 months, depending on which group you are in. Throughout this time, you'll have several visits to the clinic in Oxford. These visits will involve regular check-ups, blood tests, and discussions about how you're feeling and any side effects you might experience. Some participants will be monitored particularly closely before each new vaccination to ensure safety.

Potential risks and benefits

By taking part, you could be helping to find new ways to prevent malaria, which is a major global health challenge. However, as with any new medicine, there might be side effects from the vaccine components. These can range from mild effects like soreness at the injection site, to more serious though very rare reactions. The study team will closely monitor you for any problems. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

CCVTM, University of Oxford, Churchill Hospital
Oxford, United Kingdom

Common questions

What is malaria?

Malaria is a serious disease caused by a parasite and spread by mosquito bites. It can cause fever, chills, and flu-like illness, and can be very dangerous.

What does 'Phase 1' mean?

Phase 1 means this is one of the very first times this vaccine is being tested in people. The main goals are to check if it's safe and how your body reacts to it.

Will I get malaria from the vaccine?

No, the vaccine components themselves cannot give you malaria. They are designed to help your body build protection against the disease.

Where is the study happening?

The study is taking place at the Centre for Clinical Vaccinology and Tropical Medicine (CCVTM) in Oxford, UK.

Will I be paid for taking part?

The study information will provide details about any payment or reimbursement for expenses related to your participation.