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 States505 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 range18 Years – 60 Years

SexALL

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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…

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)

Percentage of participants reporting medically attended events (MAEs)

Timeframe: From Dose 1 (Day 1) up 12 months after last study intervention administration (Day 394)

Trial details

NCT IDNCT05298254

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-06-12

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