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

Last updated: November 6, 2024
Sponsor: GlaxoSmithKline
Overall Status: Active - Not Recruiting

Phase

1/2

Condition

Genital Herpes

Herpes Simplex Infections

Treatment

HSV formulation 1 with adjuvant 2

HSVTI_F1

Non-adjuvanted HSV formulation 1

Clinical Study ID

NCT05298254
215336
2021-003586-35
  • Ages 18-60
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • • Participants, who, in the opinion of the investigator, can and will comply withthe requirements of the Protocol.

  • Written informed consent obtained from the participant prior to performance of anystudy-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 studyintervention administration, and,

  • Has a negative pregnancy test result at the Screening visit and on the day ofeach study intervention administration, and,

  • For PART I: Has agreed to continue highly effective contraception until the endof the study.

  • For PART II: Has agreed to continue highly effective contraception until 3months after last study intervention administration.

  • Seronegative for human immunodeficiency virus (HIV), as determined by laboratoryscreening tests. Participants documented to be seropositive to HIV will not beeligible for study participation.

  • Only for PART I: Healthy participants as established by medical history and physicalexamination, 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 thefirst study intervention administration.

  • Only for PART I: Seronegative for HSV-2 as determined by Western blot performed atthe Screening visit.

  • Only for PART II: Participants with recurrent genital herpes and with no significanthealth problems as established by medical history and physical examination, at thediscretion of the investigator, before entering the study.

  • Diagnosis of genital herpes for at least one year before the Screening visit.

  • History of self-reported or documented recurrent lesional genital herpesfrequency of at least 3 and no more than 9 reported clinical recurrences in the 12 months preceding the screening visit, or, if still on suppressive therapywithin 3 months before the Screening visit, prior to initiation of suppressivetherapy.

  • Only for PART II: Man or woman aged 18 to 60 years, included, at the time of thefirst study intervention administration.

  • Only for PART II: Seropositive for HSV-2 as determined by serologicaltestingperformed at the Screening visit, or having documented laboratory-confirmedHSV 2 genital herpes (i.e., HSV-2 DNA positive by a molecular technique such aspolymerase chain reaction [PCR], or HSV-2 seropositive by a type-specific serologyassay such as Western Blot or other immunoassay).Only for PART II (sheddingsub-cohort): Participants agreeing to collect 2 swabs per day from anogenital areafor the full duration of the 5 swabbing periods planned in the study.

  • Only for PART II (shedding sub-cohort) after baseline completion: Participantshaving collected at least 45 out of 56 anogenital swabs during the baseline period.

Exclusion

Exclusion Criteria:

Medical Conditions

  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic,endocrine, or renal functional abnormality, as determined by physical examination orlaboratory screening tests.

  • Any other clinical condition that, in the opinion of the investigator, might poseadditional risk to the participant due to participation in the study or that wouldinterfere with the efficacy and immunogenicity assessments planned in this study.

  • History of any reaction or hypersensitivity likely to be exacerbated by anycomponent of the study intervention.

  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based onmedical history and physical examination.

  • Hypersensitivity to latex.

  • Recurrent history or uncontrolled neurological disorders or seizures.

  • Haematological and/or biochemical parameters outside the normal laboratory ranges atthe Screening visit, unless the laboratory abnormalities are considered notclinically significant by the investigator.

  • Body mass index =<18 kg/m^2 or >=35 kg/m^2.

  • Past or current Guillain-Barré syndrome.

  • History of any form of ocular HSV infection, HSV-related erythema multiforme, orHSV-related neurological complications.

Prior/Concomitant Therapy

  • Use of any investigational or non-registered product other than the studyintervention during the period beginning as of the Screening visit, or planned useduring the study period.

  • Planned administration/administration of a vaccine not foreseen by the Protocol inthe period starting 15 days before each dose and ending 15 days after each dose ofstudy intervention administration.

  • Administration or planned administration of long-acting immune-modifying drugs atany time during the study period.

  • Administration of immunoglobulins and/or any blood products or plasma derivativesduring the period starting 3 months before the first dose of study intervention orplanned administration during the study period.

  • Chronic administration of immunosuppressants or other immune-modifying drugs duringthe period starting 3 months prior to the first study intervention dose. Forcorticosteroids, this will mean prednisone equivalent >= 20 mg/day, or equivalent.Inhaled, intra articular and topical steroids are allowed.

  • Prior receipt of another vaccine containing HSV antigens.

  • Only for PART II: Planned use of suppressive anti-HSV therapy from the Screeningvisit until the end of the study.

  • Only for PART II: Planned use of tenofovir therapy, or other medication known toaffect HSV shedding or genital lesions from the Screening visit until the end of thestudy. Only for PART II: Planned use of topical antiviral medication in theanogenital region from the Screening visit until the end of the study.

  • Only for PART II: Planned use of any episodic antiviral medications during theswabbing periods (including the baseline period) (only for the shedding sub-cohort).

Prior/Concurrent Clinical Study Experience

• Concurrently participating in another clinical study, at any time during the study period, in which the participant has been or will be exposed to an investigational or a non-investigational intervention.

Other Exclusions

  • Pregnant or lactating women.

  • Woman planning to become pregnant or planning to discontinue contraceptiveprecautions in the period starting from the Screening visit up to 3 months post-lastdose of study intervention.

Study Design

Total Participants: 505
Treatment Group(s): 12
Primary Treatment: HSV formulation 1 with adjuvant 2
Phase: 1/2
Study Start date:
March 07, 2022
Estimated Completion Date:
July 10, 2025

Connect with a study center

  • GSK Investigational Site

    Darlinghurst, New South Wales 2010
    Australia

    Site Not Available

  • GSK Investigational Site

    Darlinghurst, Sydney, New South Wales 2010
    Australia

    Site Not Available

  • GSK Investigational Site

    Sydney, New South Wales 2010
    Australia

    Site Not Available

  • GSK Investigational Site

    Antwerpen, 2000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Brussels, 1000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Edegem, 2650
    Belgium

    Site Not Available

  • GSK Investigational Site

    Gent, 9000
    Belgium

    Site Not Available

  • GSK Investigational Site

    Wilrijk, 2610
    Belgium

    Site Not Available

  • GSK Investigational Site

    Montreal, Quebec H2L 4E9
    Canada

    Site Not Available

  • GSK Investigational Site

    Tartu, 50106
    Estonia

    Site Not Available

  • GSK Investigational Site

    Berlin, 10439
    Germany

    Site Not Available

  • GSK Investigational Site

    Bochum, 44787
    Germany

    Site Not Available

  • GSK Investigational Site

    Frankfurt, 60596
    Germany

    Site Not Available

  • GSK Investigational Site

    Hamburg, 20146
    Germany

    Site Not Available

  • GSK Investigational Site

    Koeln, 50674
    Germany

    Site Not Available

  • GSK Investigational Site

    Majadahonda, Madrid 28222
    Spain

    Site Not Available

  • GSK Investigational Site

    Badalona, 08015
    Spain

    Site Not Available

  • GSK Investigational Site

    Barcelona, 08001
    Spain

    Site Not Available

  • GSK Investigational Site

    Madrid, 28040
    Spain

    Site Not Available

  • GSK Investigational Site

    Marbella, 29600
    Spain

    Site Not Available

  • GSK Investigational Site

    Brighton, BN2 1ES
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Liverpool, L7 8XP
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    London, WC1E 6JB
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Southampton, SO14 0YG
    United Kingdom

    Site Not Available

  • GSK Investigational Site

    Phoenix, Arizona 85015
    United States

    Site Not Available

  • GSK Investigational Site

    Miami, Florida 33015
    United States

    Site Not Available

  • GSK Investigational Site

    Wichita, Kansas 67207
    United States

    Site Not Available

  • GSK Investigational Site

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • GSK Investigational Site

    Rochester, New York 14609
    United States

    Site Not Available

  • GSK Investigational Site

    Memphis, Tennessee 38120
    United States

    Site Not Available

  • GSK Investigational Site

    Richmond, Virginia 23219
    United States

    Site Not Available

  • GSK Investigational Site

    Seattle, Washington 98105
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.