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

A clinical study of the V540A vaccine in healthy adults (V540A-001)

This study, called V540A-001, is looking at a new vaccine named V540A for Human Papillomavirus, or HPV. HPV is a very common virus, and some types can cause serious health problems. This is a very early stage study, meaning it's the first time this vaccine will be given to people. Researchers want to find out if the vaccine is safe and how the body reacts to it. They will be giving it to healthy adults, aged 18 and over, to understand its effects. This important first step helps pave the way for bigger studies in the future if this vaccine shows promise.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Merck Sharp & Dohme LLC

Enrolment target

144

Start

21 Oct 2024

Human Papilloma virus

What is this study about?

This research is about a new vaccine, called V540A, for Human Papillomavirus (HPV). HPV is a common virus that can affect both men and women. Some types of HPV can cause warts, while others can lead to more serious conditions like certain cancers, including cervical cancer, if not treated. Vaccines are a way to help your body learn to fight off infections before you even get them.

This particular study is a very early step in testing the V540A vaccine. It's what scientists call a 'Phase I' study. This means it's the very first time this new vaccine will be given to people. The main goal at this stage isn't to see how well it prevents HPV, but rather to carefully check if it's safe to use.

Researchers will be giving the vaccine to healthy adult volunteers. By doing this, they can watch carefully for any side effects and understand how the body responds to the vaccine. This information is crucial before bigger studies can be done to see if the vaccine actually protects against HPV effectively.

Key takeaways

This study is testing a brand-new HPV vaccine (V540A) in people for the first time.
It's a 'Phase I' study, focused on checking the vaccine's safety.
Healthy adults, aged 18 and over, are needed as volunteers.
Taking part involves receiving the vaccine and having regular health checks.
You won't get actual HPV from the vaccine, but there could be side effects.
Your involvement helps scientists learn if this vaccine could be useful in the future.

Who may be eligible?

This study is looking for healthy adult volunteers. To be included, you must be 18 years old or older. There is no upper age limit, meaning people of all adult ages are welcome to consider taking part. This study is open to both men and women.

Because this is a very early safety study, volunteers should be generally healthy. This means you should not have any major ongoing health conditions that could interfere with the study or make taking part unsafe for you. The research team will do medical checks to make sure you fit the health requirements.

They will also check if you are taking any medicines that might affect the vaccine. You'll have a discussion with the study team and a doctor who can explain all the specific health requirements to make sure it's safe and appropriate for you to join.

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 18 years old or older?
Are you generally in good health?
Are you willing to visit the clinic for appointments?
Are you comfortable potentially receiving a new, untested vaccine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the new vaccine. The study team would closely monitor you for a period of time to see how your body reacts and if there are any side effects. You would likely need to visit the study clinic several times for health checks, blood tests, and to answer questions about how you're feeling. These visits help the doctors understand the vaccine's effects over time. The total duration of your participation in the study would be clearly explained by the research team.

Potential risks and benefits

Potential benefits of taking part are not guaranteed, but you could be helping to advance medical science and contribute to the development of a new vaccine that might protect people from HPV in the future. As with any new medicine, there are potential risks, including side effects from the vaccine. These could be mild, like a sore arm, or in rare cases, more serious. All known risks will be fully explained before you agree to take part. You have the right 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 HPV?

HPV stands for Human Papillomavirus. It's a very common virus, and some types can cause warts or, more seriously, lead to certain types of cancer.

What is a vaccine?

A vaccine helps your body's immune system learn to recognise and fight off a virus or bacteria before you get sick.

What does 'Phase I' mean?

Phase I means this is the very first time this new vaccine is being given to people. The main goal is to check its safety.

Will I get money for taking part?

Payment for participation varies between studies. The research team will tell you if any reimbursement for your time or travel expenses is offered.

Can I stop taking part if I change my mind?

Yes, you have the right to leave the study at any point, for any reason, without it affecting your usual medical care.