A study to assess the safety and efficacy of an experimental malaria vaccine by infecting vaccinated and unvaccinated volunteers with malaria parasites
This study focuses on developing new vaccines for malaria, a serious illness caused by parasites spread by mosquito bites. Malaria affects millions globally each year, with one type called Plasmodium falciparum causing the most severe cases. We're testing a new vaccine called R78C, sometimes with another vaccine named RH5.1. These vaccines are designed to help your body fight off the malaria parasite. We want to find out if they are safe and whether they can prevent or delay malaria infections. Healthy volunteers from the Oxford area are needed. Some will get the vaccine, others won't, and then some will be carefully exposed to malaria to see if the vaccine protects them. While you won't directly benefit, your participation could help create an effective malaria vaccine to protect others worldwide.
At a glance
What is this study about?
Malaria is a serious disease that can make people very sick, and in some cases, it can be fatal. It's caused by tiny parasites spread through the bite of infected mosquitoes. One type of malaria parasite, called Plasmodium falciparum, causes the most illness and deaths around the world.
Developing a vaccine that can prevent malaria is very important. This study is testing new vaccines, R78C and RH5.1, to see if they can teach your body to fight off the malaria parasite. These vaccines are made from parts of the parasite that help it enter your red blood cells. By studying these vaccines, we hope to find a safe and effective way to protect people from malaria.
We need healthy volunteers to help us understand if these experimental vaccines work. Your involvement is crucial for advancing our knowledge and potentially saving lives in the future.
Key takeaways
- This study tests new malaria vaccines for safety and effectiveness.
- Healthy volunteers aged 18-45 are needed from the Oxford area.
- Some volunteers will receive vaccines, others won't, and some will be exposed to malaria.
- Your safety is closely monitored, and any malaria infection will be treated immediately.
- Participation won't directly benefit you, but will help find a malaria vaccine for others.
- You cannot donate blood permanently if you participate in this study.
Who may be eligible?
We are looking for healthy adults between 18 and 45 years old who live in or near Oxford and are able to commit to the study's schedule. You'd need to be willing to share your medical history with your GP and allow us to look at your electronic medical records. If you can become pregnant, you must agree to use effective contraception throughout the study.
There are some health conditions that would prevent you from taking part, such as certain blood conditions like sickle cell disease or thalassaemia. Also, for your safety, we can't accept participants who weigh less than 50kg. You also need to be reachable by phone and willing to receive malaria treatment if you get infected during the study.
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.
- Are you between 18 and 45 years old?
- Are you generally healthy?
- Are you willing to discuss your medical history with your GP?
- If you can get pregnant, are you able to use reliable contraception throughout the study?
- Do you weigh 50kg or more?
- Are you able to agree to not donate blood permanently?
What does participation involve?
If you take part, you'll be one of two groups. The first group, with 13 participants, will receive three doses of the vaccine. The second group, called the 'control' group, won't receive any vaccines. Later, up to 11 people from each group will be carefully infected with malaria in a controlled setting, which we call a 'malaria challenge'. We'll then closely watch everyone to see if the vaccine works.
Throughout the study, you'll have regular check-ups to monitor your health. This includes blood tests. There's also an optional procedure called a fine needle aspiration (FNA), where a very thin needle is used to collect a small sample. If you choose to have the FNA, we'll give you more detailed information. The study is expected to run from June 2026 to May 2027.
Potential risks and benefits
Locations (1)
- -Approximate-, England
Common questions
What is malaria?
Malaria is a serious illness caused by parasites spread to humans through infected mosquito bites. It can cause fever, chills, and flu-like symptoms.
Will I definitely get malaria if I join this study?
If you are in one of the challenge groups, you might be intentionally exposed to malaria under very controlled medical supervision. We will closely monitor and treat you if you do get infected.
What are the common side effects of the vaccine?
Common side effects might include pain or redness where you had the injection, headache, tiredness, or muscle aches. These are usually mild to moderate.
Do I have to pay to participate?
No, you will not have to pay to participate in this study. All study-related care and treatments are provided by the study team.
Can I donate blood after the study?
No, because of your participation in this study, you will need to permanently refrain from donating blood, according to UK guidelines.
How to find out more
Angela Minassian
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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