A Study to Compare Two Dosing Regimens for a New Malaria Vaccine
Malaria is a serious disease, especially for young children in Africa. There's a big need for a good malaria vaccine. This study is testing an experimental vaccine called RH5.1, which is given with an extra ingredient called Matrix-M to boost its effect. Our main goals are to check if the vaccine is safe for healthy adults and how strongly their immune system responds to it. We're comparing two different schedules for giving the vaccine doses – one group gets three smaller doses, and another gets two larger doses then one smaller one. We hope to find the best and most efficient way to give this vaccine.
At a glance
What is this study about?
Malaria is a very serious illness that makes many people sick every year, and sadly, it causes many deaths, especially in young children. It's a big problem for people living in countries where malaria is common and also for travellers visiting those areas. That's why scientists are working hard to find a safe and effective vaccine to protect people from malaria.
This study is looking at a new experimental malaria vaccine, called RH5.1, to see if it's safe for people and if it helps their bodies build protection against the malaria parasite. The vaccine is given along with a special substance called Matrix-M, which is designed to make the vaccine work even better. The main aim is for your body to learn how to fight off the malaria parasite if you were to get infected.
We're trying to figure out the best way to give this vaccine. We'll be comparing two different schedules for the doses. One group will receive three doses of the vaccine at particular times, and another group will have a slightly different schedule, including a 'delayed' dose. We'll be collecting blood samples and information about any effects you feel to understand how your body reacts and to ensure the vaccine is safe.
Key takeaways
- This study tests a new malaria vaccine (RH5.1) for safety and immune response.
- Two different vaccine dosing schedules are being compared.
- Participants will receive three vaccine doses over about six months.
- Regular health checks and blood tests will monitor your well-being.
- It aims to find the best way to protect against malaria.
Who may be eligible?
To join this study, you need to be a healthy adult between 18 and 50 years old. It's important that you're willing and able to follow all the study rules and allow the study team to speak with your GP about your health history.
There are also some reasons why you might not be able to join. For example, if you've had malaria before, or if you've recently travelled to a place where malaria is common, you wouldn't be able to take part. We also can't include you if you've had certain vaccines or other experimental treatments recently, or if you have any serious allergies or conditions that affect your immune system.
If you're a woman who could become pregnant, you'll need to use reliable birth control throughout the study. Also, if you donate blood, you'd need to agree not to do so while you're in the study.
- Are you a healthy adult aged 18 to 50?
- Have you *not* had malaria before or travelled to a malaria area recently?
- Are you able to attend all study appointments over six months?
- Are you *not* currently taking part in another medical 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 receive three doses of the experimental vaccine over several months. These doses will be given at specific times: your first dose when you join, a second dose about one month later, and a final dose about six months after your first. Some participants will receive slightly different dose amounts and timings for the second and third doses to help us understand the best schedule.
During your time in the study, you'll have regular visits to the clinic. At these visits, we'll take blood samples to check your immune response and monitor your health. We'll also ask you about how you're feeling and any symptoms you might have. You'll need to report any new symptoms or changes in your health to the study team. The full study duration, from your first vaccination to your final follow-up, will be about six months.
Potential risks and benefits
Locations (1)
- Sheffield Teaching Hospitals, Royal Hallamshire HospitalSheffield, United Kingdom
Common questions
What is malaria?
Malaria is a serious disease caused by tiny parasites, usually spread through mosquito bites. It can cause fever, chills, and flu-like symptoms, and can be very dangerous if not treated.
What is the RH5.1 vaccine?
RH5.1 is an experimental vaccine being developed to help your body create protection against the malaria parasite. It’s given with an ingredient called Matrix-M to make it work better.
Will I get malaria from the vaccine?
No, you cannot get malaria from this vaccine. The vaccine uses parts of the malaria parasite, not the whole live parasite, so it's not possible to get malaria from it.
How long will the study last for me?
If you join, your involvement in the study, including all doses and follow-up visits, will take about six months.
What if I change my mind?
You can decide to leave the study at any time, for any reason. Your decision will not affect your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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