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

• ClinicalTrials.gov Identifier: NCT05298254
• Recruitment Status: Active, not recruiting
• First Posted: March 28, 2022
• Last Update Posted: April 26, 2024
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

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.

Condition or disease	Intervention/treatment	Phase
Herpes Simplex	Biological: Non-adjuvanted HSV formulation 1; Biological: Non-adjuvanted HSV formulation 2; Biological: Non-adjuvanted HSV formulation 3; Biological: HSV formulation 1 with adjuvant 1; Biological: HSV formulation 2 with adjuvant 1; Biological: HSV formulation 3 with adjuvant 1; Biological: HSV formulation 1 with adjuvant 2; Biological: HSV formulation 2 with adjuvant 2; Biological: HSV formulation 3 with adjuvant 2; Drug: Placebo; Biological: HSVTI_F1; Biological: HSVTI_F2	Phase 1; Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 342 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: Data will be collected in an observer-blind manner.
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: March 7, 2022
• Estimated Primary Completion Date: July 3, 2025
• Estimated Study Completion Date: July 5, 2026

Arms and Interventions

Arm	Intervention/treatment
Experimental: Non-adjuvanted HSV formulation 1 - Part I Group; 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.	Biological: Non-adjuvanted HSV formulation 1; 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.
Experimental: Non-adjuvanted HSV formulation 2 - Part I Group; 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.	Biological: Non-adjuvanted HSV formulation 2; 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.
Experimental: Non-adjuvanted HSV formulation 3 - Part I Group; 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.	Biological: Non-adjuvanted HSV formulation 3; 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.
Experimental: HSV formulation 1 with adjuvant 1 - Part I Group; 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.	Biological: HSV formulation 1 with adjuvant 1; 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.
Experimental: HSV formulation 2 with adjuvant 1 - Part I Group; 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.	Biological: HSV formulation 2 with adjuvant 1; 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.
Experimental: HSV formulation 3 with adjuvant 1 - Part I Group; 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.	Biological: HSV formulation 3 with adjuvant 1; 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.
Experimental: HSV formulation 1 with adjuvant 2 - Part I Group; 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.	Biological: HSV formulation 1 with adjuvant 2; 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.
Experimental: HSV formulation 2 with adjuvant 2 - Part I Group; 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.	Biological: HSV formulation 2 with adjuvant 2; 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.
Experimental: HSV formulation 3 with adjuvant 2 - Part I Group; 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.	Biological: HSV formulation 3 with adjuvant 2; 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.
Placebo Comparator: Placebo - Part I Group; Participants enrolled in Part I of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29.	Drug: Placebo; 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.
Experimental: HSVTI formulation (F) 1 - Part II Group; 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.	Biological: HSVTI_F1; 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.
Experimental: HSVTI_F2 - Part II Group; 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.	Biological: HSVTI_F2; 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.
Placebo Comparator: Placebo - Part II Group; Participants enrolled in Part II of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29.	Drug: Placebo; 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.

Outcome Measures

Primary Outcome Measures :

1. Percentage of participants reporting each solicited administration site event [ Time Frame: Within 7 days after the first study intervention dose (administered at Day 1) ]
   The solicited administration site events are pain, redness and swelling.
2. Percentage of participants reporting each solicited administration site event [ Time Frame: Within 7 days after the second study intervention dose (administered at Day 29) ]
   The solicited administration site events are pain, redness and swelling.
3. Percentage of participants reporting each solicited systemic event [ Time Frame: Within 7 days after the first study intervention dose (administered at Day 1) ]
   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.
4. Percentage of participants reporting each solicited systemic event [ Time Frame: Within 7 days after the second study intervention dose (administered at Day 29) ]
   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.
5. Percentage of participants reporting unsolicited adverse events (AEs) [ Time Frame: Within 28 days after the first study intervention dose (administered at Day 1) ]
   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.
6. Percentage of participants reporting unsolicited adverse events (AEs) [ Time Frame: Within 28 days after the second study intervention dose (administered at Day 29) ]
   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.
7. Percentage of participants reporting medically attended events (MAEs) [ Time Frame: From Dose 1 (Day 1) up 12 months after last study intervention administration (Day 394) ]
   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.
8. Percentage of participants reporting any serious adverse events (SAEs) [ Time Frame: From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394) ]
   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.
9. Percentage of participants reporting any potential immune-mediated disease (pIMDs) (classified as newly diagnosed or exacerbation of pre-existing events) [ Time Frame: From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394) ]
   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.
10. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part I of the study [ Time Frame: At pre-study intervention administration (Day 1) ]
    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.
11. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part I of the study [ Time Frame: At Day 8 ]
12. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in Part I of the study [ Time Frame: At Day 29 ]
13. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part I of the study [ Time Frame: At Day 36 ]
14. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 64 in Part I of the study [ Time Frame: At Day 64 ]
15. 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) ]
16. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part II of the study [ Time Frame: At Day 8 ]
17. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in part II of the study [ Time Frame: At Day 29 ]
18. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part II of the study [ Time Frame: At Day 36 ]
19. Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 57 in Part II of the study [ Time Frame: At Day 57 ]
20. Time-to-first confirmed HSV-2 RGH episode in Part II of the study [ Time Frame: 14 days post-Dose 2 (Day 43) to Day 759 ]
    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.

Secondary Outcome Measures :

1. Number of confirmed HSV-2 RGH episodes in Part II of the study [ Time Frame: 14 days post-Dose 2 (Day 43) to Day 759 ]
   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.
2. Percentage of participants free from confirmed HSV-2 RGH episode in Part II of the study [ Time Frame: At 6, 12, 18 and 24 months after the last study intervention administration (Day 29) ]
   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.
3. Herpes Symptoms Checklist (HSC) total score during each confirmed HSV-2 RGH episode in Part II of the study [ Time Frame: 14 days post-Dose 2 (Day 43) to Day 759 ]
   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.
4. Number of days with RGH-associated symptoms during each confirmed HSV-2 RGH episode in Part II of the study [ Time Frame: 14 days post-Dose 2 (Day 43) to Day 759 ]
   Duration in days (i.e., number of days with RGH-associated symptoms) of each genital herpes recurrence is displayed by arm group.
5. Number of days with confirmed HSV-2 genital herpes lesions in Part II of the study [ Time Frame: 14 days post-Dose 2 (Day 43) to Day 759 ]
   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.
6. HSV-2 shedding rate reduction from baseline to 6 weeks post-Dose 2 (Day 71) in Part II of the study [ Time Frame: At 6 weeks post-Dose 2 (Day 71) compared to baseline (Day -28 to Day -1) ]
   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.
7. HSV-2 shedding rate reduction from baseline to 6 months post-Dose 2 (Day 209) in Part II of the study [ Time Frame: At 6 months post-Dose 2 (Day 209) compared to baseline (Day -28 to Day -1) ]
   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.
8. HSV-2 shedding rate reduction from baseline to 12 months post-Dose 2 (Day 394) in Part II of the study [ Time Frame: At 12 months post-Dose 2 (Day 394) compared to baseline (Day -28 to Day -1) ]
   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.
9. HSV-2 shedding rate reduction from baseline to 24 months post-Dose 2 (Day 759) in Part II of the study [ Time Frame: At 24 months post-Dose 2 (Day 759) compared to baseline (Day -28 to Day -1) ]
   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.
10. Number of HSV-2 DNA shedding episodes in Part II of the study [ Time Frame: Day -28 to Day -1 ]
    Number of HSV-2 shedding episodes during the 28-day swabbing period.
11. Number of HSV-2 DNA shedding episodes in Part II of the study [ Time Frame: Day 43 to Day 70 ]
    Number of HSV-2 shedding episodes during the 28-day swabbing period.
12. Number of HSV-2 DNA shedding episodes in Part II of the study [ Time Frame: Day 181 to Day 208 ]
    Number of HSV-2 shedding episodes during the 28-day swabbing period.
13. Number of HSV-2 DNA shedding episodes in Part II of the study [ Time Frame: Day 366 to Day 393 ]
    Number of HSV-2 shedding episodes during the 28-day swabbing period.
14. Number of HSV-2 DNA shedding episodes in Part II of the study [ Time Frame: Day 731 to Day 758 ]
    Number of HSV-2 shedding episodes during the 28-day swabbing period.
15. Duration of HSV-2 DNA shedding episodes in Part II of the study [ Time Frame: Day -28 to Day -1 ]
    Number of days of a HSV-2 shedding episode.
16. Duration of HSV-2 DNA shedding episodes in Part II of the study [ Time Frame: Day 43 to Day 70 ]
    Number of days of a HSV-2 shedding episode.
17. Duration of HSV-2 DNA shedding episodes in Part II of the study [ Time Frame: Day 181 to Day 208 ]
    Number of days of a HSV-2 shedding episode.
18. Duration of HSV-2 DNA shedding episodes in Part II of the study [ Time Frame: Day 366 to Day 393 ]
    Number of days of a HSV-2 shedding episode.
19. Duration of HSV-2 DNA shedding episodes in Part II of the study [ Time Frame: Day 731 to Day 758 ]
    Number of days of a HSV-2 shedding episode.
20. 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 ]
21. 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 ]
22. 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 ]
23. 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 ]
24. 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 ]
25. 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 ]
26. 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 ]
27. 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 ]
28. 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 [ Time Frame: From Dose 1 (Day 1) up to study end (Day 759) ]
    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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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 lesional 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 still on suppressive therapy within 3 months before the Screening visit, 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 serological testingperformed at the Screening visit, or having documented laboratory-confirmed HSV 2 genital herpes (i.e., HSV-2 DNA positive by a molecular technique such as polymerase chain reaction [PCR], or HSV-2 seropositive by a type-specific serology assay such as Western Blot or other immunoassay).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. 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 swabbing 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 contraceptive precautions in the period starting from the Screening visit up to 3 months post-last dose of study intervention.

Contacts and Locations

Locations

United States, Arizona

GSK Investigational Site

Phoenix, Arizona, United States, 85015

United States, Florida

GSK Investigational Site

Miami, Florida, United States, 33015

United States, Kansas

GSK Investigational Site

Wichita, Kansas, United States, 67207

United States, Missouri

GSK Investigational Site

Kansas City, Missouri, United States, 64114

United States, New York

GSK Investigational Site

Rochester, New York, United States, 14609

United States, Virginia

GSK Investigational Site

Richmond, Virginia, United States, 23219

United States, Washington

GSK Investigational Site

Seattle, Washington, United States, 98105

Australia, New South Wales

GSK Investigational Site

Darlinghurst, Sydney, New South Wales, Australia, 2010

GSK Investigational Site

Sydney, New South Wales, Australia, 2010

Belgium

GSK Investigational Site

Antwerpen, Belgium, 2000

GSK Investigational Site

Brussels, Belgium, 1000

GSK Investigational Site

Edegem, Belgium, 2650

GSK Investigational Site

Gent, Belgium, 9000

Canada, Quebec

GSK Investigational Site

Montreal, Quebec, Canada, H2L 4E9

Estonia

GSK Investigational Site

Tartu, Estonia, 50106

Germany

GSK Investigational Site

Frankfurt, Hessen, Germany, 60596

GSK Investigational Site

Bochum, Nordrhein-Westfalen, Germany, 44787

GSK Investigational Site

Koeln, Nordrhein-Westfalen, Germany, 50674

GSK Investigational Site

Berlin, Germany, 10117

GSK Investigational Site

Berlin, Germany, 10439

GSK Investigational Site

Hamburg, Germany, 20146

Spain

GSK Investigational Site

Majadahonda, Madrid, Spain, 28222

GSK Investigational Site

Barcelona, Spain, 08001

GSK Investigational Site

Barcelona, Spain, ?08015

GSK Investigational Site

Madrid, Spain, 28010

GSK Investigational Site

Madrid, Spain, 28040

GSK Investigational Site

Marbella, Spain, 29600

United Kingdom

GSK Investigational Site

Brighton, East Sussex, United Kingdom, BN2 1ES

GSK Investigational Site

Liverpool, United Kingdom, L7 8XP

GSK Investigational Site

London, United Kingdom, WC1E 6JB

GSK Investigational Site

Southampton, United Kingdom, SO14 0YG

Sponsors and Collaborators

GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials; GlaxoSmithKline

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT05298254
• Other Study ID Numbers: 215336; 2021-003586-35 ( EudraCT Number )
• First Posted: March 28, 2022
• Last Update Posted: April 26, 2024
• Last Verified: April 2024

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: IPD for this study will be made available via the Clinical Study Data Request site.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• 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.
• 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.

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by GlaxoSmithKline:

First Time in Human; Healthy participants; Recurrent genital herpes; Herpes Simplex Virus; Reactogenicity; Safety; Immune response; Efficacy

Additional relevant MeSH terms:

Herpes Simplex; Herpes Genitalis; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Sexually Transmitted Diseases, Viral; Sexually Transmitted Diseases; Communicable Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Genital Diseases, Male; Male Urogenital Diseases