Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

A Phase I, randomized, double-blind, multi-centre, placebo-controlled, dose-escalation study to evaluate the safety, reactogenicity and immunogenicity of AstriVax’ investigational vaccine for the prevention of yellow fever (AVX70120), and of AstriVax’ investigational vaccine for the prevention of rabies (AVX70481), in healthy adults aged 18 to 40 years.

This research study is looking at two new vaccines developed by AstriVax. One vaccine aims to prevent yellow fever, and the other aims to prevent rabies. This is a "Phase I" study, meaning it's the very first time these vaccines are being given to humans. The main goal is to see if the vaccines are safe and if they cause any side effects in healthy adults between 18 and 40 years old. Researchers will also check if the vaccines help the body build a defence (an immune response) against these diseases. Participants will receive either one of the new vaccines or a dummy treatment (placebo) to help scientists understand the vaccine's effects better. This type of study is crucial for developing future protections against serious illnesses like yellow fever and rabies.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

AstriVax

Enrolment target

144

Start

13 Jun 2024

Yellow fever Rabies

What is this study about?

This study is a really important step in developing new vaccines to protect against two serious diseases: yellow fever and rabies. Yellow fever is a virus spread by mosquitoes in certain parts of the world, and it can cause severe illness. Rabies is a very dangerous virus, usually caught from the bite of an infected animal, and it's almost always fatal once symptoms appear. Currently, there are vaccines for both, but scientists are always working to find even better ones.

This particular study is what we call a 'Phase I' trial. This means it's the very first time these specific vaccines are being given to people. The main focus at this stage isn't to see how well they prevent diseases yet, but rather to carefully check if they are safe and if they cause any unwanted side effects. Researchers will also be looking to see if the vaccines help the body create an immune response, which is a sign that the vaccine is working to build protection.

The research involves healthy adults aged 18 to 40. They will receive either one of the new vaccines or a placebo (a dummy injection that looks like the vaccine but has no active ingredients). This helps researchers compare the effects accurately. Everything is done very carefully, with regular check-ups and monitoring, to make sure participants are safe throughout the study.

Key takeaways

This study is testing two new vaccines for yellow fever and rabies for the first time in people.
The main goal is to check how safe the vaccines are and if they cause any side effects.
Healthy adults aged 18 to 40 are needed for the study.
Participants will receive either a new vaccine or a dummy injection (placebo).
You will receive careful medical check-ups throughout the study.

Who may be eligible?

This study is looking for healthy adults between 18 and 40 years old. Both men and women are welcome to take part. Researchers need people who are generally well and don't have any major health problems that could affect how the vaccine works or their safety during the study.

There might be some specific reasons someone can't join. For example, if you have certain health conditions, are taking particular medications, or have had certain vaccinations recently, you might not be suitable. This is to ensure the safety of everyone taking part and the accuracy of the study results.

Everything will be checked very carefully by the study doctors to make sure it's safe for you to participate. You'll have a chance to ask any questions you have about whether you're a good fit for 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 40 years old?
Are you generally healthy with no major ongoing medical conditions?
Are you able to attend regular study appointments?
Are you comfortable with receiving injections and having blood tests?
Have you spoken to the study team about any other vaccines you've had recently or medications you are taking?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll first have a screening visit to check if you're eligible. This might involve blood tests and a health check-up. If you qualify, you'll be randomly assigned to receive either one of the new vaccines or a placebo (a dummy injection). You won't know which one you're getting, and neither will the study team, to keep the results fair.

There will be a few study visits over several weeks or months where you'll have check-ups, blood samples taken, and perhaps other assessments to see how you're doing and how your body is responding to the vaccine. There will also be some follow-up calls or visits to monitor your health for a period after your last dose. The doctors and nurses will explain the exact schedule and what's involved in detail before you agree to anything. The total duration of your involvement will be clearly explained.

Potential risks and benefits

Taking part in any medical study has potential benefits and potential risks. A potential benefit could be helping scientists develop new vaccines that could save lives in the future. You will also receive careful medical monitoring throughout the study. However, there's always a possibility of experiencing side effects from the vaccines, which could include things like soreness at the injection site, fever, or other reactions, some of which might be unexpected. The study doctors will explain all known or potential risks in detail. Remember, you can choose to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

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

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Unverified
Belgium

Common questions

What is a Phase I study?

A Phase I study is the first time a new medicine or vaccine is given to people. It mainly checks for safety and how the body reacts to it.

What is a placebo?

A placebo is a 'dummy' treatment that looks just like the real vaccine but contains no active ingredients. It helps scientists compare the effects of the vaccine accurately.

Will I know if I'm getting the vaccine or the placebo?

No, in this study, neither you nor the doctors will know if you're getting the vaccine or the placebo. This is called 'double-blind' and helps keep the results unbiased.

What if I experience side effects?

The study team will monitor you closely for any side effects. You will have a way to contact them if you feel unwell, and they will provide care and advice.

Will I be paid to take part?

Many clinical trials offer some payment for your time and travel expenses. This will be openly discussed with you before you agree to participate.