A multicentre, open-label trial in healthy volunteers to assess the boostability of three different rabies pre-exposure prophylaxis regimens when administering a single-dose, intramuscular vaccination as simulated post-exposure prophylaxis at least five years following priming. "BAZOOKA_221"
This research, called "BAZOOKA_221", is for healthy adults. It aims to understand how effective a rabies booster shot is for people who were vaccinated against rabies at least five years ago. We're testing three different ways of giving the booster vaccination called Rabipur. This vaccine helps protect against rabies, a very serious disease. The main goal is to see what percentage of people develop a strong enough immune response to rabies seven days after receiving the booster. We will also check this response at other times and look for any side effects. This information will help doctors understand the best way to protect people from rabies in the long term, especially if they are at risk of exposure.
At a glance
What is this study about?
This study, known as "BAZOOKA_221", is an important research project focused on protecting people from rabies. Rabies is a very serious illness that affects the brain and nerves, and it's almost always fatal once symptoms appear. Fortunately, vaccines can prevent it. Many people, especially those who travel or work with animals, get vaccinated against rabies before they might be exposed. This initial vaccination is called 'pre-exposure prophylaxis'.
Sometimes, even after getting vaccinated, a person might be bitten by an animal suspected of having rabies. In such cases, a 'post-exposure prophylaxis' treatment, which often includes a booster shot, is given to strengthen the body's protection. This study wants to find out the best way to give this booster shot to people who had their initial rabies vaccinations at least five years ago. We're using a specific rabies vaccine called Rabipur.
The main aim is to see how many people develop a good level of protection (measured by special blood tests) seven days after getting the booster shot. We'll also be watching closely for any side effects. The results will help doctors understand how to best protect people who have been previously vaccinated against rabies, ensuring they have the strongest possible shield against this dangerous disease if they ever need it.
Key takeaways
- This study evaluates rabies booster shots for long-term protection.
- It helps understand the best approach for pre-vaccinated individuals.
- The focus is on how well the body responds to the booster.
- The study also monitors for any side effects from the vaccine.
- Taking part helps improve rabies prevention strategies.
- You must be a healthy adult aged 18 or over to participate.
Who may be eligible?
This study is looking for healthy adult volunteers. If you are 18 years old or older, you might be able to take part. There is no upper age limit for joining.
Both men and women are welcome to participate in this research. The most important requirement is that you feel well and are considered healthy by medical standards.
While the exact details will be checked by the study team, the main criteria are your age and general health status.
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.
- Am I 18 years old or older?
- Am I generally healthy?
- Have I previously been vaccinated against rabies?
- Was my last rabies vaccination at least five years ago?
What does participation involve?
If you decide to take part in this study, you will first have a screening visit to check if you meet all the requirements. If you do, you will receive a single dose of the Rabipur rabies vaccine as a booster shot, given into a muscle. This is similar to a standard vaccination.
After you get the booster, you'll have several follow-up visits. The main checks will be to take blood samples on Day 7 and Day 14 after the booster to see how your body is responding to the vaccine. We will also take a blood sample on the day you get the booster, before the shot.
Throughout the study, the research team will regularly check in with you to monitor your health and look for any side effects. You might be asked about any local reactions (like soreness or redness where you got the injection) or other general symptoms such as headache or tiredness. The total duration of your participation in the study, from your vaccination to the final check-up, will be clearly explained by the study team.
Potential risks and benefits
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Common questions
What is rabies?
Rabies is a very serious disease that attacks the brain and nerves. It's almost always fatal once symptoms appear, but it can be prevented with vaccines.
What is a booster shot?
A booster shot is an additional dose of a vaccine given after your initial vaccination to help keep your immune system strong and protect you for longer.
What is being tested in this study?
This study is testing how well different ways of giving a rabies booster shot work in people who were vaccinated against rabies at least five years ago.
Will I get rabies from the vaccine?
No, the vaccine used in this study (Rabipur) contains inactivated (non-active) rabies virus, so it cannot cause rabies disease.
What is an 'immune response'?
An immune response is how your body's defence system reacts to a vaccine, by creating protective substances called antibodies to fight off future infections.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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