TH HSV REC-003

Evaluating a new immunotherapy that aims to reduce the frequency, severity and duration of genital herpes outbreaks

The Clinical Trial Centre of ITM is seeking volunteers for a new clinical trial entitled TH HSV REC-003. In this study, we will evaluate a new immunotherapy that aims to reduce the frequency, severity and duration of genital herpes outbreaks.

For whom: You are 18-60 years old, have been diagnosed with genital herpes for at least 1 year and have experienced 3-9 outbreaks in the last year
Start: January 2024
Duration: About 2 years
Study visits: Between 10 and 16 visits to the study centre
Compensation: Fixed compensation per study visit, for self-swabbing and for completing a study diary

Purpose of the study

Genital herpes is a common sexually transmitted infection caused by the herpes simplex virus (HSV), mainly by HSV-2. Sexual contact is the primary way the virus spreads and can be passed from person to person without being noticed. After the initial infection, the virus lies dormant in your body and can reactivate several times a year. Many people who have genital herpes have no symptoms or have very mild symptoms. Others may have sores appearing as one or more blisters on or around the genitals or rectum. These sores may take a week or more to heal.

There is no cure for genital herpes. However, there are medications that can prevent or shorten outbreaks. These medications can be taken daily and some can make it less likely that you will pass the infection on to your sex partner(s). However, the medications only work while they are being taken.

The sponsor is currently developing a potential new treatment for genital herpes that could help reduce the frequency, severity and duration of outbreaks. The treatment has not yet been approved in any countries to date. This means that this treatment is only given to people who take part in research studies. This study is being done to test if the treatment is well tolerated and how well it works. The study aims to understand how it could help to protect against recurrent outbreaks of genital herpes in people already infected with the virus.

Conduct of the study

During an initial visit, your eligibility to participate in the study will be verified. Only if you meet all the criteria will you receive the treatment. However, know that not all participants will receive the treatment. Some participants will receive the treatment and other participants will receive a placebo. This allocation is done in a completely random manner, and until the end of the study, neither you nor the study staff will know whether you received the new treatment or the placebo.

One month after the first dose, you will receive a second dose. Furthermore, you will be expected to donate blood samples during the study visits, take self-swabs at regular intervals, and fill out an electronic diary (with information about any side effects after administration of the treatment, any medications you are taking, information about the swabs, and any signs or symptoms of genital herpes you experience).

Anyway, the study doctor will go over the contents of the study in detail with you during your first visit. Please know that you have the right to decide not to participate in the study at any time.

Who can participate?

You MAY join this study if you:

are between the ages of 18-60 years old
have been diagnosed with genital herpes for at least 1 year
are confirmed to be infected by the HSV-2 virus and test negative for HIV
have had multiple outbreaks in the last year OR before you started suppressive therapy (if applicable)
don’t use PrEP for HIV prevention.

Note that there are other criteria that need to be checked to help decide if you can participate in the study. These will be gone over with the study doctor during the first study visit.

Compensation

A fixed fee is provided per study visit. There is also compensation for the time you spend filling out the diary and possibly taking swabs. You will receive more details at your first study visit.