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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

Primary Purpose

Herpes Simplex

Status
Active
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Non-adjuvanted HSV formulation 1
Non-adjuvanted HSV formulation 2
Non-adjuvanted HSV formulation 3
HSV formulation 1 with adjuvant 1
HSV formulation 2 with adjuvant 1
HSV formulation 3 with adjuvant 1
HSV formulation 1 with adjuvant 2
HSV formulation 2 with adjuvant 2
HSV formulation 3 with adjuvant 2
Placebo
HSVTI_F1
HSVTI_F2
Sponsored by
GlaxoSmithKline
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Herpes Simplex focused on measuring First Time in Human, Healthy participants, Recurrent genital herpes, Herpes Simplex Virus, Reactogenicity, Safety, Immune response, Efficacy

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

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 may be enrolled in the study.
  • Women of childbearing potential may 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,
    • Has agreed to continue highly effective contraception until the end of the study.
  • 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 with recurrent HSV-2 genital herpes and with no significant health problems as established by medical history and physical examination, at the discretion of the investigator, before entering the study.

    • Diagnosis of genital HSV-2 infection for at least one year before the Screening visit.
    • History of recurrent genital herpes defined as at least 3 and no more than 9 reported clinical recurrences in the 12 months preceding the screening visit, or, if currently on suppressive therapy, prior to initiation of suppressive therapy.
  • Only for PART II: Man or woman aged 18 to 60 years, included, at the time of the first study intervention administration.
  • Only for PART II: Seropositive for HSV-2 as determined by Western blot performed at the Screening visit.
  • Only for PART II: Participants agreeing to collect 2 swabs per day from anogenital area for the full duration of the 4 swabbing periods planned in the study.
  • Only for PART II after baseline completion: Participants having collected at least 45 out of 56 anogenital swabs during the baseline period.

Exclusion Criteria:

Medical Conditions

  • Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality, as determined by physical examination or laboratory screening tests.
  • Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study or that would interfere with the efficacy and immunogenicity assessments planned in this study.
  • History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention.
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical 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 at the Screening visit, unless the laboratory abnormalities are considered not clinically significant by the investigator.
  • Body mass index ≤ 18 kg/m^2 or ≥ 35 kg/m^2.
  • History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications.
  • Only for PART II: History of laboratory-confirmed genital HSV-1 infection.

Prior/Concomitant Therapy

  • Use of any investigational or non-registered product other than the study intervention during the period beginning as of the Screening visit, or planned use during the study period.
  • Planned administration/administration of a vaccine not foreseen by the Protocol in the period starting 15 days before each dose and ending 15 days after each dose of study intervention administration.
  • Administration or planned administration of long-acting immune-modifying drugs at any time during the study period.
  • Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study intervention or planned administration during the study period.
  • Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose. For corticosteroids, 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 Screening visit until the end of the study.
  • Only for PART II: Planned use of tenofovir therapy, or other medication known to affect HSV shedding or genital lesions from the Screening visit until the end of the study.
  • Only for PART II: Planned use of topical antiviral medication in the anogenital region from the Screening visit until the end of the study.
  • Only for PART II: Planned use of any episodic antiviral medications during the 4 anogenital swabbing periods and during the first genital herpes recurrence occurring after administration of the 2 doses of the study intervention.

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 contraceptive precautions.

Sites / Locations

  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site
  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm 9

Arm 10

Arm 11

Arm 12

Arm 13

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Experimental

Experimental

Placebo Comparator

Arm Label

Non-adjuvanted HSV formulation 1 - Part I Group

Non-adjuvanted HSV formulation 2 - Part I Group

Non-adjuvanted HSV formulation 3 - Part I Group

HSV formulation 1 with adjuvant 1 - Part I Group

HSV formulation 2 with adjuvant 1 - Part I Group

HSV formulation 3 with adjuvant 1 - Part I Group

HSV formulation 1 with adjuvant 2 - Part I Group

HSV formulation 2 with adjuvant 2 - Part I Group

HSV formulation 3 with adjuvant 2 - Part I Group

Placebo - Part I Group

HSVTI formulation (F) 1 - Part II Group

HSVTI_F2 - Part II Group

Placebo - Part II Group

Arm Description

Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 1 vaccine, one at Day 1 and one at Day 29.

Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 2 vaccine, one at Day 1 and one at Day 29.

Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 3 vaccine, one at Day 1 and one at Day 29.

Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 1 vaccine, one at Day 1 and one at Day 29.

Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 1 vaccine, one at Day 1 and one at Day 29.

Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 1 vaccine, one at Day 1 and one at Day 29.

Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 2 vaccine, one at Day 1 and one at Day 29.

Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 2 vaccine, one at Day 1 and one at Day 29.

Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 2 vaccine, one at Day 1 and one at Day 29.

Participants enrolled in Part I of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29.

Participants enrolled in Part II of the study who receive 2 doses of the formulation of the HSVTI_F1 selected from Part I of the study, one at Day 1 and one at Day 29.

Participants enrolled in Part II of the study who receive 2 doses of the HSVTI_F2 selected from Part I of the study, one at Day 1 and one at Day 29.

Participants enrolled in Part II of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29.

Outcomes

Primary Outcome Measures

Percentage of participants reporting each solicited administration site event
The solicited administration site events are pain, redness and swelling.
Percentage of participants reporting each solicited administration site event
The solicited administration site events are pain, redness and swelling.
Percentage of participants reporting each solicited systemic event
The solicited systemic events are fever, fatigue, headache, myalgia and arthralgia. The preferred location for measuring temperature is the oral cavity. Fever is defined as temperature equal to or above (≥) 38.0 degree Celsius (°C)/ 100.4 degree Fahrenheit (°F), regardless the location of measurement.
Percentage of participants reporting each solicited systemic event
The solicited systemic events are fever, fatigue, headache, myalgia and arthralgia. The preferred location for measuring temperature is the oral cavity. Fever is defined as temperature equal to or above (≥) 38.0 degree Celsius (°C)/ 100.4 degree Fahrenheit (°F), regardless the location of measurement.
Percentage of participants reporting unsolicited adverse events (AEs)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms (7 days after each dose) is reported as an unsolicited AE.
Percentage of participants reporting unsolicited adverse events (AEs)
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms (7 days after each dose) is reported as an unsolicited AE.
Percentage of participants reporting medically attended events (MAEs)
An MAE is an unsolicited AE for which the participants received medical attention defined as any symptoms or illnesses requiring hospitalization, or an emergency room visit, or visit to/by healthcare professionals.
Percentage of participants reporting any serious adverse events (SAEs)
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.
Percentage of participants reporting any potential immune-mediated disease (pIMDs) (classified as newly diagnosed or exacerbation of pre-existing events)
PIMDs are a subset of adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part I of the study
Clinically significant haematological and biochemical abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part I of the study
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in Part I of the study
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part I of the study
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 64 in Part I of the study
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part II of the study
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part II of the study
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in part II of the study
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part II of the study
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 57 in Part II of the study
Time-to-first confirmed HSV-2 RGH episode in Part II of the study
A suspected RGH episode will be classified as confirmed HSV-2 RGH episode if at least one of the lesional or anogenital swabs taken during the concerned episode is positive for HSV-2 as measured by PCR.
Time-to-first confirmed RGH episodes of any HSV type in Part II of the study
A suspected RGH episode is classified as confirmed HSV-1 and HSV-2 RGH episode if at least one of the lesional or anogenital swabs taken during the concerned episode is positive for HSV-1 and HSV-2 as measured by PCR.

Secondary Outcome Measures

Number of confirmed RGH episodes of any HSV type in Part II of the study
A suspected RGH episode will be classified as confirmed HSV-1 and HSV-2 RGH episode if at least one of the lesional or anogenital swabs taken during the concerned episode is positive for HSV-1 and HSV-2 as measured by PCR.
Percentage of participants free from confirmed RGH episode of any HSV type in Part II of the study
A suspected RGH episode will be classified as confirmed HSV-1 and HSV-2 RGH episode if at least one of the lesional or anogenital swabs taken during the concerned episode is positive for HSV-1 and HSV-2 as measured by PCR.
Herpes Symptoms Checklist (HSC) total score during each confirmed RGH episode of any HSV type in Part II of the study
During genital herpes recurrences, participants are asked to complete the HSC, a 13-item checklist of herpes symptoms, where respondents record the severity of symptoms on a 4-point scale where 0 indicates no symptom and a higher point for more symptoms and severity. Total scores range from 0 (no symptom) to 39 (severe symptoms). At the onset of the genital herpes recurrence, this questionnaire is to be completed once daily, until no lesions or symptoms are present.
Number of days with RGH-associated symptoms during each confirmed RGH episode of any HSV type in Part II of the study
Duration in days (i.e., number of days with RGH-associated symptoms) of each genital herpes recurrence is displayed by arm group.
Number of days with confirmed genital herpes lesions of any HSV type in Part II of the study
Number of days on which lesions (swelling, blisters, sores, or crusts) are reported by the participant in the anogenital area during confirmed RGH episodes divided by the number of days of follow-up.
HSV-2 shedding rate reduction from baseline to 6 weeks post-Dose 2 (Day 71) in Part II of the study
The HSV-2 shedding rate reduction is calculated as 1- (the HSV-2 shedding rate one month post-Dose 2 divided by the baseline HSV-2 shedding rate)*100.
HSV-2 shedding rate reduction from baseline to 6 months post-Dose 2 (Day 209) in Part II of the study
The HSV-2 shedding rate reduction is calculated as 1 - (the HSV-2 shedding rate 6 months post-Dose 2 divided by the baseline HSV-2 shedding rate)*100.
HSV-2 shedding rate reduction from baseline to 12 months post-Dose 2 (Day 394) in Part II of the study
The HSV-2 shedding rate reduction is calculated as 1 - (the HSV-2 shedding rate 12 months post-Dose 2 divided by the baseline HSV-2 shedding rate)*100.
HSV-2 shedding rate reduction from baseline to 24 months post-Dose 2 (Day 759) in Part II of the study
The HSV-2 shedding rate reduction is calculated as 1 - (the HSV-2 shedding rate 24 months post-Dose 2 divided by the baseline HSV-2 shedding rate)*100.
Number of HSV DNA shedding episodes in Part II of the study
Number of HSV shedding episodes during the 28-day swabbing period.
Number of HSV DNA shedding episodes in Part II of the study
Number of HSV shedding episodes during the 28-day swabbing period.
Number of HSV DNA shedding episodes in Part II of the study
Number of HSV shedding episodes during the 28-day swabbing period.
Number of HSV DNA shedding episodes in Part II of the study
Number of HSV shedding episodes during the 28-day swabbing period.
Number of HSV DNA shedding episodes in Part II of the study
Number of HSV shedding episodes during the 28-day swabbing period.
Duration of HSV DNA shedding episodes in Part II of the study
Number of days of a HSV shedding episode.
Duration of HSV DNA shedding episodes in Part II of the study
Number of days of a HSV shedding episode.
Duration of HSV DNA shedding episodes in Part II of the study
Number of days of a HSV shedding episode.
Duration of HSV DNA shedding episodes in Part II of the study
Number of days of a HSV shedding episode.
Duration of HSV DNA shedding episodes in Part II of the study
Number of days of a HSV shedding episode.
Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part I of the study
Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part II of the study
Percentage of seropositive participants for anti-HSVTI antibodies in Part I of the study
Percentage of seropositive participants for anti-HSVTI antibodies in Part II of the study
Geometric mean of HSVTI-specific Cluster of Differentiation (CD)4+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the study
Geometric mean of HSVTI-specific CD4+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the study
Geometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the study
Geometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the study
Percentage of participants with a fatal SAE, SAE related to study intervention and potential immune-mediated disease (pIMDs) related to study intervention in Part II of the study
A SAE related to study intervention is an SAE judged by the investigator as related to the study intervention. A fatal SAE is any untoward medical occurrence that results in death.

Full Information

First Posted
March 4, 2022
Last Updated
October 3, 2023
Sponsor
GlaxoSmithKline
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1. Study Identification

Unique Protocol Identification Number
NCT05298254
Brief Title
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
Official Title
A Phase I/II, Observer-blind, Randomised, Placebo-controlled, Multi-country Study to Evaluate Reactogenicity, Safety, Immune Response, and Efficacy of an HSV-targeted Immunotherapy in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 7, 2022 (Actual)
Primary Completion Date
May 19, 2025 (Anticipated)
Study Completion Date
March 31, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Herpes Simplex
Keywords
First Time in Human, Healthy participants, Recurrent genital herpes, Herpes Simplex Virus, Reactogenicity, Safety, Immune response, Efficacy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Data will be collected in an observer-blind manner.
Allocation
Randomized
Enrollment
332 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Non-adjuvanted HSV formulation 1 - Part I Group
Arm Type
Experimental
Arm Description
Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 1 vaccine, one at Day 1 and one at Day 29.
Arm Title
Non-adjuvanted HSV formulation 2 - Part I Group
Arm Type
Experimental
Arm Description
Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 2 vaccine, one at Day 1 and one at Day 29.
Arm Title
Non-adjuvanted HSV formulation 3 - Part I Group
Arm Type
Experimental
Arm Description
Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 3 vaccine, one at Day 1 and one at Day 29.
Arm Title
HSV formulation 1 with adjuvant 1 - Part I Group
Arm Type
Experimental
Arm Description
Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 1 vaccine, one at Day 1 and one at Day 29.
Arm Title
HSV formulation 2 with adjuvant 1 - Part I Group
Arm Type
Experimental
Arm Description
Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 1 vaccine, one at Day 1 and one at Day 29.
Arm Title
HSV formulation 3 with adjuvant 1 - Part I Group
Arm Type
Experimental
Arm Description
Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 1 vaccine, one at Day 1 and one at Day 29.
Arm Title
HSV formulation 1 with adjuvant 2 - Part I Group
Arm Type
Experimental
Arm Description
Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 2 vaccine, one at Day 1 and one at Day 29.
Arm Title
HSV formulation 2 with adjuvant 2 - Part I Group
Arm Type
Experimental
Arm Description
Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 2 vaccine, one at Day 1 and one at Day 29.
Arm Title
HSV formulation 3 with adjuvant 2 - Part I Group
Arm Type
Experimental
Arm Description
Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 2 vaccine, one at Day 1 and one at Day 29.
Arm Title
Placebo - Part I Group
Arm Type
Placebo Comparator
Arm Description
Participants enrolled in Part I of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29.
Arm Title
HSVTI formulation (F) 1 - Part II Group
Arm Type
Experimental
Arm Description
Participants enrolled in Part II of the study who receive 2 doses of the formulation of the HSVTI_F1 selected from Part I of the study, one at Day 1 and one at Day 29.
Arm Title
HSVTI_F2 - Part II Group
Arm Type
Experimental
Arm Description
Participants enrolled in Part II of the study who receive 2 doses of the HSVTI_F2 selected from Part I of the study, one at Day 1 and one at Day 29.
Arm Title
Placebo - Part II Group
Arm Type
Placebo Comparator
Arm Description
Participants enrolled in Part II of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29.
Intervention Type
Biological
Intervention Name(s)
Non-adjuvanted HSV formulation 1
Intervention Description
Two doses of the non-adjuvanted HSV formulation 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
Intervention Type
Biological
Intervention Name(s)
Non-adjuvanted HSV formulation 2
Intervention Description
Two doses of the non-adjuvanted HSV formulation 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
Intervention Type
Biological
Intervention Name(s)
Non-adjuvanted HSV formulation 3
Intervention Description
Two doses of the non-adjuvanted HSV formulation 3 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
Intervention Type
Biological
Intervention Name(s)
HSV formulation 1 with adjuvant 1
Intervention Description
Two doses of the HSV formulation 1 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
Intervention Type
Biological
Intervention Name(s)
HSV formulation 2 with adjuvant 1
Intervention Description
Two doses of the HSV formulation 2 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
Intervention Type
Biological
Intervention Name(s)
HSV formulation 3 with adjuvant 1
Intervention Description
Two doses of the HSV formulation 3 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
Intervention Type
Biological
Intervention Name(s)
HSV formulation 1 with adjuvant 2
Intervention Description
Two doses of the HSV formulation 1 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
Intervention Type
Biological
Intervention Name(s)
HSV formulation 2 with adjuvant 2
Intervention Description
Two doses of the HSV formulation 2 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
Intervention Type
Biological
Intervention Name(s)
HSV formulation 3 with adjuvant 2
Intervention Description
Two doses of the HSV formulation 3 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Two doses of Placebo administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I and Part II of the study.
Intervention Type
Biological
Intervention Name(s)
HSVTI_F1
Intervention Description
Two doses of the formulation of the HSVTI_F1 selected from Part I of the study administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part II of the study.
Intervention Type
Biological
Intervention Name(s)
HSVTI_F2
Intervention Description
Two doses of the formulation of the HSVTI_F2 selected from Part I of the study administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part II of the study.
Primary Outcome Measure Information:
Title
Percentage of participants reporting each solicited administration site event
Description
The solicited administration site events are pain, redness and swelling.
Time Frame
Within 7 days after the first study intervention dose (administered at Day 1)
Title
Percentage of participants reporting each solicited administration site event
Description
The solicited administration site events are pain, redness and swelling.
Time Frame
Within 7 days after the second study intervention dose (administered at Day 29)
Title
Percentage of participants reporting each solicited systemic event
Description
The solicited systemic events are fever, fatigue, headache, myalgia and arthralgia. The preferred location for measuring temperature is the oral cavity. Fever is defined as temperature equal to or above (≥) 38.0 degree Celsius (°C)/ 100.4 degree Fahrenheit (°F), regardless the location of measurement.
Time Frame
Within 7 days after the first study intervention dose (administered at Day 1)
Title
Percentage of participants reporting each solicited systemic event
Description
The solicited systemic events are fever, fatigue, headache, myalgia and arthralgia. The preferred location for measuring temperature is the oral cavity. Fever is defined as temperature equal to or above (≥) 38.0 degree Celsius (°C)/ 100.4 degree Fahrenheit (°F), regardless the location of measurement.
Time Frame
Within 7 days after the second study intervention dose (administered at Day 29)
Title
Percentage of participants reporting unsolicited adverse events (AEs)
Description
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms (7 days after each dose) is reported as an unsolicited AE.
Time Frame
Within 28 days after the first study intervention dose (administered at Day 1)
Title
Percentage of participants reporting unsolicited adverse events (AEs)
Description
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms (7 days after each dose) is reported as an unsolicited AE.
Time Frame
Within 28 days after the second study intervention dose (administered at Day 29)
Title
Percentage of participants reporting medically attended events (MAEs)
Description
An MAE is an unsolicited AE for which the participants received medical attention defined as any symptoms or illnesses requiring hospitalization, or an emergency room visit, or visit to/by healthcare professionals.
Time Frame
From Dose 1 (Day 1) up 12 months after last study intervention administration (Day 394)
Title
Percentage of participants reporting any serious adverse events (SAEs)
Description
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.
Time Frame
From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394)
Title
Percentage of participants reporting any potential immune-mediated disease (pIMDs) (classified as newly diagnosed or exacerbation of pre-existing events)
Description
PIMDs are a subset of adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurologic disorders of interest which may or may not have an autoimmune aetiology.
Time Frame
From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394)
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part I of the study
Description
Clinically significant haematological and biochemical abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
Time Frame
At pre-study intervention administration (Day 1)
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part I of the study
Time Frame
At Day 8
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in Part I of the study
Time Frame
At Day 29
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part I of the study
Time Frame
At Day 36
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 64 in Part I of the study
Time Frame
At Day 64
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part II of the study
Time Frame
At pre-study intervention administration (Day 1)
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part II of the study
Time Frame
At Day 8
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in part II of the study
Time Frame
At Day 29
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part II of the study
Time Frame
At Day 36
Title
Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 57 in Part II of the study
Time Frame
At Day 57
Title
Time-to-first confirmed HSV-2 RGH episode in Part II of the study
Description
A suspected RGH episode will be classified as confirmed HSV-2 RGH episode if at least one of the lesional or anogenital swabs taken during the concerned episode is positive for HSV-2 as measured by PCR.
Time Frame
14 days post-Dose 2 (Day 43) to Day 759
Title
Time-to-first confirmed RGH episodes of any HSV type in Part II of the study
Description
A suspected RGH episode is classified as confirmed HSV-1 and HSV-2 RGH episode if at least one of the lesional or anogenital swabs taken during the concerned episode is positive for HSV-1 and HSV-2 as measured by PCR.
Time Frame
14 days post-Dose 2 (Day 43) to Day 759
Secondary Outcome Measure Information:
Title
Number of confirmed RGH episodes of any HSV type in Part II of the study
Description
A suspected RGH episode will be classified as confirmed HSV-1 and HSV-2 RGH episode if at least one of the lesional or anogenital swabs taken during the concerned episode is positive for HSV-1 and HSV-2 as measured by PCR.
Time Frame
14 days post-Dose 2 (Day 43) to Day 759
Title
Percentage of participants free from confirmed RGH episode of any HSV type in Part II of the study
Description
A suspected RGH episode will be classified as confirmed HSV-1 and HSV-2 RGH episode if at least one of the lesional or anogenital swabs taken during the concerned episode is positive for HSV-1 and HSV-2 as measured by PCR.
Time Frame
At 6, 12, 18 and 24 months after the last study intervention administration (Day 29)
Title
Herpes Symptoms Checklist (HSC) total score during each confirmed RGH episode of any HSV type in Part II of the study
Description
During genital herpes recurrences, participants are asked to complete the HSC, a 13-item checklist of herpes symptoms, where respondents record the severity of symptoms on a 4-point scale where 0 indicates no symptom and a higher point for more symptoms and severity. Total scores range from 0 (no symptom) to 39 (severe symptoms). At the onset of the genital herpes recurrence, this questionnaire is to be completed once daily, until no lesions or symptoms are present.
Time Frame
14 days post-Dose 2 (Day 43) to Day 759
Title
Number of days with RGH-associated symptoms during each confirmed RGH episode of any HSV type in Part II of the study
Description
Duration in days (i.e., number of days with RGH-associated symptoms) of each genital herpes recurrence is displayed by arm group.
Time Frame
14 days post-Dose 2 (Day 43) to Day 759
Title
Number of days with confirmed genital herpes lesions of any HSV type in Part II of the study
Description
Number of days on which lesions (swelling, blisters, sores, or crusts) are reported by the participant in the anogenital area during confirmed RGH episodes divided by the number of days of follow-up.
Time Frame
14 days post-Dose 2 (Day 43) to Day 759
Title
HSV-2 shedding rate reduction from baseline to 6 weeks post-Dose 2 (Day 71) in Part II of the study
Description
The HSV-2 shedding rate reduction is calculated as 1- (the HSV-2 shedding rate one month post-Dose 2 divided by the baseline HSV-2 shedding rate)*100.
Time Frame
At 6 weeks post-Dose 2 (Day 71) compared to baseline (Day -28 to Day -1)
Title
HSV-2 shedding rate reduction from baseline to 6 months post-Dose 2 (Day 209) in Part II of the study
Description
The HSV-2 shedding rate reduction is calculated as 1 - (the HSV-2 shedding rate 6 months post-Dose 2 divided by the baseline HSV-2 shedding rate)*100.
Time Frame
At 6 months post-Dose 2 (Day 209) compared to baseline (Day -28 to Day -1)
Title
HSV-2 shedding rate reduction from baseline to 12 months post-Dose 2 (Day 394) in Part II of the study
Description
The HSV-2 shedding rate reduction is calculated as 1 - (the HSV-2 shedding rate 12 months post-Dose 2 divided by the baseline HSV-2 shedding rate)*100.
Time Frame
At 12 months post-Dose 2 (Day 394) compared to baseline (Day -28 to Day -1)
Title
HSV-2 shedding rate reduction from baseline to 24 months post-Dose 2 (Day 759) in Part II of the study
Description
The HSV-2 shedding rate reduction is calculated as 1 - (the HSV-2 shedding rate 24 months post-Dose 2 divided by the baseline HSV-2 shedding rate)*100.
Time Frame
At 24 months post-Dose 2 (Day 759) compared to baseline (Day -28 to Day -1)
Title
Number of HSV DNA shedding episodes in Part II of the study
Description
Number of HSV shedding episodes during the 28-day swabbing period.
Time Frame
Day -28 to Day -1
Title
Number of HSV DNA shedding episodes in Part II of the study
Description
Number of HSV shedding episodes during the 28-day swabbing period.
Time Frame
Day 43 to Day 70
Title
Number of HSV DNA shedding episodes in Part II of the study
Description
Number of HSV shedding episodes during the 28-day swabbing period.
Time Frame
Day 181 to Day 208
Title
Number of HSV DNA shedding episodes in Part II of the study
Description
Number of HSV shedding episodes during the 28-day swabbing period.
Time Frame
Day 366 to Day 393
Title
Number of HSV DNA shedding episodes in Part II of the study
Description
Number of HSV shedding episodes during the 28-day swabbing period.
Time Frame
Day 731 to Day 758
Title
Duration of HSV DNA shedding episodes in Part II of the study
Description
Number of days of a HSV shedding episode.
Time Frame
Day -28 to Day -1
Title
Duration of HSV DNA shedding episodes in Part II of the study
Description
Number of days of a HSV shedding episode.
Time Frame
Day 43 to Day 70
Title
Duration of HSV DNA shedding episodes in Part II of the study
Description
Number of days of a HSV shedding episode.
Time Frame
Day 181 to Day 208
Title
Duration of HSV DNA shedding episodes in Part II of the study
Description
Number of days of a HSV shedding episode.
Time Frame
Day 366 to Day 393
Title
Duration of HSV DNA shedding episodes in Part II of the study
Description
Number of days of a HSV shedding episode.
Time Frame
Day 731 to Day 758
Title
Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part I of the study
Time Frame
At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Title
Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part II of the study
Time Frame
At pre-study intervention administration (Day 1), Day 29, Day 57, Day 209 and Day 394, Day 574, and Day 759
Title
Percentage of seropositive participants for anti-HSVTI antibodies in Part I of the study
Time Frame
At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Title
Percentage of seropositive participants for anti-HSVTI antibodies in Part II of the study
Time Frame
At pre-study intervention administration (Day 1), Day 29, Day 57, Day 209 and Day 394, Day 574, and Day 759
Title
Geometric mean of HSVTI-specific Cluster of Differentiation (CD)4+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the study
Time Frame
At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Title
Geometric mean of HSVTI-specific CD4+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the study
Time Frame
At pre-study intervention administration (Day 1), Day 29, Day 57, Day 209 and Day 394, Day 574, and Day 759
Title
Geometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least two activation markers and including at least one cytokine in Part I of the study
Time Frame
At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394
Title
Geometric mean of HSVTI-specific CD8+ T-cells frequency expressing at least 2 activation markers and including at least 1 cytokine in Part II of the study
Time Frame
At pre-study intervention administration (Day 1), Day 29, Day 57, Day 209 and Day 394, Day 574, and Day 759
Title
Percentage of participants with a fatal SAE, SAE related to study intervention and potential immune-mediated disease (pIMDs) related to study intervention in Part II of the study
Description
A SAE related to study intervention is an SAE judged by the investigator as related to the study intervention. A fatal SAE is any untoward medical occurrence that results in death.
Time Frame
From Dose 1 (Day 1) up to study end (Day 759)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 with recurrent genital herpes and with no significant health problems as established by medical history and physical examination, at the discretion 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 genital herpes frequency of at least 3 and no more than 9 reported clinical recurrences in the 12 months preceding the screening visit, or, if currently on suppressive therapy, prior to initiation of suppressive therapy. Only for PART II: Man or woman aged 18 to 60 years, included, at the time of the first study intervention administration. Only for PART II: Seropositive for HSV-2 as determined by Western blot performed at the Screening visit or having experienced a genital herpes recurrence during the screening period tested positive for HSV-1 DNA or HSV-2 DNA by polymerase chain reaction (PCR). Only for PART II (shedding sub-cohort): Participants agreeing to collect 2 swabs per day from anogenital area for the full duration of the 5 swabbing periods planned in the study. Only for PART II (shedding sub-cohort) after baseline completion: Participants having collected at least 45 out of 56 anogenital swabs during the baseline period. Exclusion Criteria: Medical Conditions Acute or chronic clinically significant pulmonary, cardiovascular, hepatic, endocrine, or renal functional abnormality, as determined by physical examination or laboratory screening tests. Any other clinical condition that, in the opinion of the investigator, might pose additional risk to the participant due to participation in the study or that would interfere with the efficacy and immunogenicity assessments planned in this study. History of any reaction or hypersensitivity likely to be exacerbated by any component of the study intervention. Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical 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 at the Screening visit, unless the laboratory abnormalities are considered not clinically 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, or HSV-related neurological complications. Prior/Concomitant Therapy Use of any investigational or non-registered product other than the study intervention during the period beginning as of the Screening visit, or planned use during the study period. Planned administration/administration of a vaccine not foreseen by the Protocol in the period starting 15 days before each dose and ending 15 days after each dose of study intervention administration. Administration or planned administration of long-acting immune-modifying drugs at any time during the study period. Administration of immunoglobulins and/or any blood products or plasma derivatives during the period starting 3 months before the first dose of study intervention or planned administration during the study period. Chronic administration of immunosuppressants or other immune-modifying drugs during the period starting 3 months prior to the first study intervention dose. For corticosteroids, 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 Screening visit until the end of the study. Only for PART II: Planned use of tenofovir therapy, or other medication known to affect HSV shedding or genital lesions from the Screening visit until the end of the study. A participant may start or resume suppressive antiviral therapy after having experienced at least 2 suspected RGH episodes with onset on Day 43 or later and if the RGH frequency is unacceptably high at the discretion of the investigator. Only for PART II: Planned use of topical antiviral medication in the anogenital region from the Screening visit until the end of the study. Only for PART II: Planned use of any episodic antiviral medications during the 5 anogenital swabbing periods (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 contraceptive precautions in the period starting from the Screening visit up to 3 months post-last dose of study intervention.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85015
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
GSK Investigational Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
GSK Investigational Site
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64114
Country
United States
Facility Name
GSK Investigational Site
City
Rochester
State/Province
New York
ZIP/Postal Code
14609
Country
United States
Facility Name
GSK Investigational Site
City
Memphis
State/Province
Tennessee
ZIP/Postal Code
38120
Country
United States
Facility Name
GSK Investigational Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23219
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Facility Name
GSK Investigational Site
City
Darlinghurst, Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
GSK Investigational Site
City
Sydney
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
GSK Investigational Site
City
Antwerpen
ZIP/Postal Code
2000
Country
Belgium
Facility Name
GSK Investigational Site
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
GSK Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
GSK Investigational Site
City
Gent
ZIP/Postal Code
9000
Country
Belgium
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4E9
Country
Canada
Facility Name
GSK Investigational Site
City
Tartu
ZIP/Postal Code
50106
Country
Estonia
Facility Name
GSK Investigational Site
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60596
Country
Germany
Facility Name
GSK Investigational Site
City
Bochum
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
44787
Country
Germany
Facility Name
GSK Investigational Site
City
Koeln
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
50674
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
GSK Investigational Site
City
Berlin
ZIP/Postal Code
10439
Country
Germany
Facility Name
GSK Investigational Site
City
Hamburg
ZIP/Postal Code
20146
Country
Germany
Facility Name
GSK Investigational Site
City
Majadahonda
State/Province
Madrid
ZIP/Postal Code
28222
Country
Spain
Facility Name
GSK Investigational Site
City
Badalona
ZIP/Postal Code
08916
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
08001
Country
Spain
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
?08015
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28010
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28040
Country
Spain
Facility Name
GSK Investigational Site
City
Marbella
ZIP/Postal Code
29600
Country
Spain
Facility Name
GSK Investigational Site
City
Brighton
State/Province
East Sussex
ZIP/Postal Code
BN2 1ES
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Liverpool
ZIP/Postal Code
L7 8XP
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
WC1E 6JB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Southampton
ZIP/Postal Code
SO14 0YG
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
IPD for this study will be made available via the Clinical Study Data Request site.
IPD Sharing Time Frame
IPD will be made available within 6 months of publishing the results of the primary endpoints, a key secondary endpoints and safety data of the study.
IPD Sharing Access Criteria
Access is provided after a research proposal is submitted and has received approval from the Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension can be granted, when justified, for up to another 12 months.

Learn more about this trial

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

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