Ongoing, recruitingPhase I and Phase II (Integrated)- First administration to humansInterventional

A Phase I/II, observer-blind, randomised, placebo-controlled, multi-country study to evaluate reactogenicity, safety, immune response, and efficacy of an HSV-targeted immunotherapy in healthy participants aged 18-40 years or in participants aged 18-60 years with recurrent genital herpes.

This study is looking into a new treatment for the herpes simplex virus, which causes cold sores and genital herpes. It's a two-part study. In the first part, researchers are checking how safe the treatment is for healthy people aged 18-40. In the second part, they are checking its safety and how well it works for people aged 18-60 who get recurrent genital herpes. Some participants will receive the new treatment, while others will receive a dummy treatment (a saline solution, which is like salty water) to compare results. The study aims to see what side effects might occur and how the body reacts to the treatment over about a year.

At a glance

Status

Ongoing, recruiting

Phase

Phase I and Phase II (Integrated)- First administration to humans

Sponsor

GlaxoSmithKline Biologicals

Enrolment target

407

Start

15 May 2024

Herpes Simplex

What is this study about?

This study is designed to learn more about a new treatment for the herpes simplex virus. This virus is responsible for common conditions like cold sores and recurrent genital herpes. The treatment is a type of immunotherapy, which means it works with your body's immune system to fight the virus. Researchers want to understand if this new treatment is safe and if it can help people who experience recurring outbreaks of genital herpes.

The study has two main parts. The first part involves healthy volunteers, aged 18 to 40, who will help researchers understand the treatment's basic safety and how the body reacts to it. The second part focuses on people aged 18 to 60 who regularly get genital herpes outbreaks. In this group, the researchers will continue to monitor safety but also start to look at whether the treatment can reduce the number or severity of herpes outbreaks. To get reliable information, some participants will receive the active treatment, while others will receive a "dummy" treatment, called a placebo, which is just a saline (salty water) solution. This allows researchers to fairly compare the effects of the new treatment against doing nothing differently.

Over the course of the study, which lasts for about a year after the last dose, researchers will carefully monitor participants for any side effects, both mild and serious. They will also collect blood samples to see how the body's immune system responds to the treatment and keep track of any genital herpes outbreaks. The ultimate goal is to see if this new treatment could be a safe and effective way to help people manage their herpes simplex virus.

Key takeaways

The study is testing a new immune-boosting treatment for herpes simplex.
It aims to check the treatment's safety and effectiveness for recurrent genital herpes.
Some participants will be healthy, others will have recurrent genital herpes.
A placebo (dummy treatment) will be used for comparison.
Participation involves clinic visits, health checks, and blood tests.
The study monitors participants for about a year after the last treatment dose.

Who may be eligible?

To join this study, you need to be an adult, either between 18 and 40 years old if you are healthy, or between 18 and 60 years old if you experience recurrent genital herpes.

All participants, regardless of their health status, must be adults. The study involves both men and women.

There will be other specific things the doctors look for to make sure the study is a good fit for you and that taking part is safe. They will check your general health and may ask about your medical history.

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 60 years old?
If you are healthy, are you between 18 and 40 years old?
Do you get recurrent outbreaks of genital herpes (if over 40)?
Are you willing to attend regular clinic visits for about a year?
Are you able to provide consent (agreement) to take part?

Answer every question to see your result.

What does participation involve?

If you join this study, you will receive either the new treatment or a placebo (a dummy injection of saline solution). Neither you nor the study doctor will know which one you are getting, to keep the results fair. You will have several visits to the clinic throughout the study period. During these visits, doctors will check your health, ask about any side effects you might be having, and take blood samples.

You will be monitored closely, especially after each dose of the treatment, to record any reactions at the injection site (like redness or pain) or general body reactions (like fever or tiredness). Researchers will also check for any other unexpected health problems. The study will involve follow-up for up to 12 months after your last dose of the study treatment to ensure all safety information is collected. The exact number of visits and tests will be explained in detail by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from receiving a new treatment that could help manage your recurrent genital herpes, or you could simply help advance medical science. However, the treatment is still being tested, so there's a chance it might not help you or could cause side effects. These side effects could range from mild, like pain or redness at the injection site, to more serious issues. The study team will explain all known risks. Remember, your participation is completely voluntary, and you are free to withdraw from the study at any time, for any reason, without affecting your medical care.

Locations (4)

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

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Unverified
Estonia
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Unverified
Belgium
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Unverified
Spain
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Unverified
Germany

Common questions

What is 'recurrent genital herpes'?

This means you get repeated outbreaks of genital herpes, rather than just one episode.

What is a 'placebo'?

A placebo is a 'dummy' treatment, like a saline (salty water) injection, that contains no active medicine. It's used to compare against the real treatment.

Who is paying for this study?

The information provided doesn't state who is funding the study. You can ask the study team for this detail.

Will I know if I'm getting the real treatment or the placebo?

No, neither you nor your study doctor will know whether you are receiving the active treatment or the placebo. This helps ensure the study results are unbiased.

How long will I be involved in the study?

You'll be monitored for up to 12 months after your last dose of the study treatment to check for any long-term effects.