TH HSV REC-003
Research type
Research Study
Full title
A Phase I/II, observer-blind, randomised, placebo controlled, multi-country study to evaluate reactogenicity, safety, immune response, and efficacy of an HSV vaccine in healthy participants aged 18-40 years or in participants aged 18-60 years with recurrent HSV-2 genital herpes
IRAS ID
1007116
Contact name
Lan Lin
Contact email
Sponsor organisation
GlaxoSmithKline Biologicals SA
Eudract number
2021-003586-35
Clinicaltrials.gov Identifier
Research summary
Herpes infection is caused by two viruses: herpes simplex virus (HSV) type 1 (HSV-1) and type 2 (HSV-2). Both viruses can cause painful blisters or ulcers at the site of infection, most commonly the mouth (oral herpes or ‘cold sores’) and genitals (genital herpes). HSV infection can also be asymptomatic. HSV can be passed from one person to another by sexual or oral contact with an infected person. Existing treatment options for genital herpes include antivirals which can be taken for few days to treat an episode of genital herpes (episodic therapy), or for several months to reduce the severity and frequency of genital herpes symptoms (suppressive therapy). Antivirals cannot cure the infection.
GlaxoSmithKline is currently developing a vaccine against genital herpes caused by HSV-2. This study, funded by GlaxoSmithKline will first test this vaccine in healthy people (PART I), then in people infected with HSV-2 (PART II). Around 245 people (aged 18-40) will take part in PART I and around 87 people (aged 18-60) will take part in PART II. UK study participants will only take part in PART II.
Two thirds of participants in PART II (approximately 58 people) will receive two HSV vaccine injections, and a one third will receive two placebo injections. Study participants will be regularly monitored, which will involve blood tests, physical examinations, vital signs, swabbing of anogenital area and completion of an e-diary. The total study duration is around 15 months, and participants would need to visit the clinic about 15 times.
The study will compare the two groups (HSV vaccine vs placebo) to investigate whether the study vaccine is well-tolerated and if the study vaccine could possibly decrease the reappearance of genital herpes symptoms as well as evaluate the study vaccine’s impact on the duration and severity of genital herpes symptoms in this population.REC name
North East - York Research Ethics Committee
REC reference
23/NE/0018
Date of REC Opinion
23 Feb 2023
REC opinion
Further Information Favourable Opinion