CompletedPhase 1/2

A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes

United States, Australia, Belgium505 participantsStarted 2022-03-07

Plain-language summary

The purpose of this first-time-in-human (FTiH) study is to evaluate the reactogenicity, safety, immune response, and efficacy of an investigational herpes simplex virus (HSV)-targeted immunotherapy (TI). The study will be conducted in 2 parts: Part I assessing different formulations of the Herpes Simplex Virus-targeted immunotherapy (HSVTI) in healthy participants aged 18-40 years; Part II assessing the 2 formulations of the HSVTI in participants aged 18-60 years with recurrent genital herpes.

Who can participate

Age range

18 Years – 60 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * • Participants, who, in the opinion of the investigator, can and will comply with the requirements of the Protocol. * Written informed consent obtained from the participant prior to performance of any study-specific procedure. * Women of non-childbearing potential can be enrolled in the study. * Women of childbearing potential can be enrolled in the study, if the participant: * Has practiced highly effective contraception for one month prior to study intervention administration, and, * Has a negative pregnancy test result at the Screening visit and on the day of each study intervention administration, and, * For PART I: Has agreed to continue highly effective contraception until the end of the study. * For PART II: Has agreed to continue highly effective contraception until 3 months after last study intervention administration. * Seronegative for human immunodeficiency virus (HIV), as determined by laboratory screening tests. Participants documented to be seropositive to HIV will not be eligible for study participation. * Only for PART I: Healthy participants as established by medical history and physical examination, at the discretion of the investigator, before entering into the study. * Only for PART I: Man or woman aged 18 to 40 years, included, at the time of the first study intervention administration. * Only for PART I: Seronegative for HSV-2 as determined by Western blot performed at the Screening visit. * Only for PART II: Participants…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Percentage of participants reporting each solicited administration site event

Timeframe: Within 7 days after the first study intervention dose (administered at Day 1)

Percentage of participants reporting each solicited administration site event

Timeframe: Within 7 days after the second study intervention dose (administered at Day 29)

Percentage of participants reporting each solicited systemic event

Timeframe: Within 7 days after the first study intervention dose (administered at Day 1)

Percentage of participants reporting each solicited systemic event

Timeframe: Within 7 days after the second study intervention dose (administered at Day 29)

Percentage of participants reporting unsolicited adverse events (AEs)

Timeframe: Within 28 days after the first study intervention dose (administered at Day 1)

Percentage of participants reporting unsolicited adverse events (AEs)

Timeframe: Within 28 days after the second study intervention dose (administered at Day 29)

Trial details

NCT IDNCT05298254

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-12

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