Active not recruitingPHASE1INTERVENTIONAL

A Phase 1 Study to Assess an Escalating Dose, Multi-prime Vaccination Schedule of R21/Matrix-M™

This study is looking into a new malaria vaccine called R21/Matrix-M™. Malaria is a serious illness caused by parasites spread by mosquitoes, and this vaccine focuses on one common type, Plasmodium falciparum. We're testing it in healthy adults aged 18 to 50 who haven't had malaria before. The main goals are to make sure the vaccine is safe and to see how effectively it helps the body build protection against malaria. We're trying out different ways of giving the vaccine, including a few doses close together. Participants will be followed for up to two years, and we'll check their blood and take small samples from their armpit area to understand how their immune system reacts to the vaccine.

At a glance

Status

Active not recruiting

Phase

PHASE1

Sponsor

University of Oxford

Enrolment target

Start

25 Mar 2024

Estimated completion

01 Jun 2027

Malaria,Falciparum

What is this study about?

Malaria is a serious disease that can make people very sick, and in some cases, it can be life-threatening. It's caused by tiny parasites spread through mosquito bites. This particular study is focusing on a new vaccine called R21/Matrix-M™, which aims to protect against a common and dangerous type of malaria called Plasmodium falciparum. The vaccine is currently in an early testing stage, known as Phase 1, which means we're primarily checking its safety and how the body responds to it in a small group of people.

We're inviting healthy adults who are 18 to 50 years old and haven't had malaria before to take part. The study will look at different ways of giving the vaccine, some with more doses and some with fewer, to see which approach works best for building protection. By understanding how the body's immune system reacts to these different vaccination schedules, researchers can decide the best way to use the vaccine in the future.

This research is really important because a successful malaria vaccine could save many lives and significantly reduce the burden of this disease, especially in areas where malaria is common. Taking part helps scientists gather vital information that could lead to new ways of preventing malaria.

Key takeaways

This study is testing a new malaria vaccine, R21/Matrix-M™, in healthy adults.
It's a Phase 1 study, focusing on vaccine safety and how the body's immune system responds.
Participants will receive the vaccine and have regular check-ups, including blood tests and two small armpit samples.
The study lasts up to two years and involves different vaccine dosing schedules.
You must be 18-50 years old and have never had malaria to join.
Your participation helps advance research for a potential new malaria prevention tool.

Who may be eligible?

To join this study, we're looking for healthy adults between the ages of 18 and 50. It's important that you haven't had malaria before and haven't traveled to places where malaria is common recently. You also can't have participated in other malaria vaccine studies in the past.

There are also some reasons why you might not be able to join. For example, if you're pregnant, breastfeeding, or planning to get pregnant during the study, you wouldn't be eligible. We also can't include people with serious long-term health conditions, certain allergies, or those who have had specific treatments like blood transfusions or medicines that suppress the immune system recently. You also can't have taken part in another medical study involving new medicines in the last month.

If you're a woman who could become pregnant, you'll need to use effective birth control throughout the study. Everyone needs to be willing and able to follow all the study instructions and give their permission to take part.

Quick self-check

Are you between 18 and 50 years old?
Have you *never* had malaria before?
Are you healthy and don't have certain long-term medical conditions?
Are you not pregnant, breastfeeding, or planning to get pregnant during the study?
Have you *not* recently taken part in another medical study involving a new medicine?
Are you willing to attend regular clinic visits and follow study instructions for up to two years?

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 in this study, you'll receive the R21/Matrix-M™ vaccine. Some participants will get six doses over time, while others will get two standard doses. All vaccine injections will be given in the same arm. The study will last for up to two years from your first vaccine dose.

During this time, you'll have several visits to the clinic. At these visits, we'll take blood samples to see how your immune system is reacting to the vaccine. You'll also undergo a procedure called a 'fine needle aspiration' twice during the study. This involves taking a very small sample from a lymph node in your armpit (the same arm where you get the vaccine) to learn more about your body's immune response. We'll give you a local anaesthetic, like that used by a dentist, to numb the area beforehand to make it as comfortable as possible. We will closely monitor your health throughout the study.

Potential risks and benefits

Taking part in this study means you're helping scientists learn more about a potential new vaccine to fight malaria, which could ultimately benefit many people worldwide. However, as with any medical study, there are potential risks, such as mild side effects from the vaccine like soreness or redness at the injection site, or discomfort from blood draws and the armpit sample. You will be closely monitored for any reactions. It's important to remember that participating is entirely voluntary, and you have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Centre for Clinical Vaccinology and Tropical Meducine, Churchill Hospital, University of Oxford
Oxford, United Kingdom
University Hospitals Bristol and Weston NHS Foundation Trust
Bristol, United Kingdom

Common questions

What is malaria?

Malaria is a serious disease caused by parasites spread to people through the bites of infected mosquitoes. It can cause fever, chills, and flu-like illness.

What is a Phase 1 study?

A Phase 1 study is the first step in testing a new medicine or vaccine in people. The main goals are to check if it's safe and to see how the body reacts to it, usually with a small group of participants.

What is R21/Matrix-M™?

R21/Matrix-M™ is the name of the new malaria vaccine being tested in this study. It's designed to help your body build protection against the malaria parasite.

Will I get malaria during the study?

No, you will not be exposed to malaria in this study. We are testing the vaccine in healthy adults who have never had malaria and who won't be traveling to malaria-prone areas.

What is a fine needle aspiration?

This is a minor procedure where a very thin needle is used to take a small sample of fluid or cells from a lymph node in your armpit. It helps us understand your immune response to the vaccine. A local anaesthetic will be used to numb the area.