EPI-HSV-006 BOD TH
Research type
Research Study
Full title
A descriptive, prospective, multi-country, multicentre study to assess performance of genital Herpes Simplex Virus-2 (HSV-2) related disease endpoints based on patient-reported health outcomes, self-swabbing collected via decentralised approach in patients ≥ 18 years of age in the United States and Europe.
IRAS ID
297390
Contact name
Janet Wilson
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals SA (GSK)
Duration of Study in the UK
2 years, 4 months, 13 days
Research summary
Genital Herpes is an infection normally caused by a virus called Herpes Simplex virus type 2 (HSV-2). Herpes Simplex virus type 1 (HSV-1) is a similar virus that causes oral herpes but can sometimes cause genital herpes.
Both viruses are easy to catch by oral or sexual contact with an infected person. Genital herpes is a lifelong infection. Sometimes, the virus can be in the body but not cause any symptoms (‘asymptomatic’ infection). When this happens, it can be passed from person to person without being noticed.
Some patients experience recurrent symptomatic episodes. These recurrences can cause uncomfortable physical symptoms and can impact sexual health, social relationships, psychological wellbeing and quality of life.
This study, funded by GlaxoSmithKline, aims to better understand HSV-2 genital herpes. It will look at the symptoms people experience, their frequency, severity and duration. This study will evaluate the impact of the disease on quality-of-life. This will allow researchers to improve their knowledge of genital herpes. Studies like this one, looking at the patterns and effects of a disease in people and are called ‘epidemiological’ studies.
About 500 people aged 18 years and above who are infected with HSV-2 will take part in this study in Europe and United States. In the UK, Genito-Urinary Medicine (GUM) clinics will take part in this study.
Participants will attend 3 planned visits at a GUM clinic and will be followed up for about 2 years.
Participants will have a physical examination and be asked questions about their general health and lifestyle, the medications they are currently taking and their genital herpes disease. Blood samples and swabs will be collected. Participants will be asked to self-swab their genital herpes lesions and complete electronic questionnaires each time they have a recurrence of the symptoms.REC name
South Central - Hampshire B Research Ethics Committee
REC reference
21/SC/0141
Date of REC Opinion
21 Jun 2021
REC opinion
Further Information Favourable Opinion