Active not recruitingPHASE3INTERVENTIONAL

R21/Matrix-M in African Children Against Clinical Malaria

This important study is looking into a new vaccine called R21/Matrix-M, designed to protect children in Africa from malaria. Malaria is a serious illness, and finding effective ways to prevent it is crucial. Researchers are testing this vaccine in children aged 5 to 36 months to see how well it works and if it's safe in the long term. Some children will receive the malaria vaccine, while others will receive a control vaccine like a rabies or hepatitis A vaccine. The study will also explore if booster doses are helpful over several years. This information will help us understand the best way to use this new vaccine to fight malaria.

At a glance

Status

Active not recruiting

Phase

PHASE3

Sponsor

University of Oxford

Enrolment target

4,800

Start

29 Apr 2021

Estimated completion

01 Apr 2028

Malaria

What is this study about?

This study is a big research project looking at a new vaccine called R21/Matrix-M, which is designed to protect children from malaria. Malaria is a serious illness spread by mosquitoes, mainly in warmer parts of the world like Africa, and it can be very dangerous for young children. Scientists are trying to find the best ways to prevent it, and this new vaccine could be an important step.

In this study, researchers want to see how effective the R21/Matrix-M vaccine is at stopping children from getting malaria. They also want to understand if it's safe for children and how long the protection might last. To do this, they're dividing children into groups, with some receiving the malaria vaccine and others receiving a different vaccine that doesn't protect against malaria (like a rabies or hepatitis A vaccine). This helps them compare the results fairly.

The study will follow the children for several years, including giving some extra 'booster' doses of the vaccine. These boosters are like top-ups to see if they help the vaccine work better or for longer. The goal is to gather as much information as possible to make sure that if this vaccine is approved, it can be used in the most effective way to help protect children from malaria.

Key takeaways

Tests a new malaria vaccine (R21/Matrix-M) in young African children.
Compares the new vaccine to other routine vaccines (rabies, hepatitis A).
Evaluates how well the vaccine protects against malaria and its safety.
Investigates the best number and timing of booster doses over several years.
Participation involves multiple vaccine shots and health check-ups over an extended period.

Who may be eligible?

This study is looking for young children between 5 months and 3 years old (36 months) to take part. To be considered, the child's parent or guardian must agree for them to join by signing a consent form. The child should also live permanently in the study area and be expected to stay there for the whole study period.

There are some reasons why a child might not be able to join. For example, if they've already had a malaria vaccine or are participating in another malaria study. Also, children with certain serious health conditions, severe allergies to vaccines, major birth defects, or severe malnutrition are not able to be in this study. The medical team will check all these things carefully to make sure it's safe for a child to participate.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Is my child between 5 months and 3 years old?
Am I willing and able to give my signed permission for my child to join?
Does my child live permanently in the study area and plan to stay there?
Has my child never received a malaria vaccine before?
Does my child have any serious allergies to vaccines or major health problems?
Is my child not currently taking part in another malaria study?

Answer every question to see your result.

What does participation involve?

If a child joins this study, they will receive several vaccine doses over time. In the beginning, they'll get three vaccine shots. About a year after the third shot, they'll get a fourth 'booster' shot. The study will then continue for two more years to look at safety and how well the vaccine works over a longer period. During this extended time, some children might receive one or two more booster shots, depending on which group they are in. Throughout the study, medical staff will check on their health and development. The total duration of participation could be several years, as children will be followed for 12 months after their final booster dose.

Potential risks and benefits

Taking part in a study like this could offer potential benefits, such as contributing to scientific understanding and potentially helping to protect your child from malaria if they receive the active vaccine. However, as with any medical treatment, there are potential risks, like temporary side effects from the vaccines (e.g., pain at the injection site, fever). The study is carefully designed to minimise risks, and your child's health will be closely monitored. You have the right to withdraw your child from the study at any time without giving a reason, and this will not affect their future medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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

Common questions

What is malaria?

Malaria is a serious disease caused by a parasite, spread to humans through the bites of infected mosquitoes. It can cause fever, chills, and flu-like illness, and can be very dangerous, especially for young children.

What is a 'booster' vaccine?

A booster vaccine is an extra dose of a vaccine given after the first few doses. It helps to remind your body's immune system how to fight the disease, making the protection stronger and last longer.

Why are some children given a different vaccine?

To fairly test if the new malaria vaccine works, some children receive it, and others receive a different, approved vaccine (like for rabies or hepatitis A). This helps researchers compare the results and be sure any effects are due to the malaria vaccine being tested.

How long will the study last for my child?

The study will follow your child for several years. They will have initial vaccinations, a booster dose about a year later, and then potentially one or two more boosters after that, with follow-up continuing for 12 months after their last booster.

What are the possible side effects of the vaccine?

Like most vaccines, there could be temporary side effects such as soreness, redness, or swelling where the injection was given, or a mild fever. The study team will monitor your child closely for any reactions.