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
NCT ID: NCT05298254
Last Updated: 2025-09-08
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
505 participants
INTERVENTIONAL
2022-03-07
2025-06-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
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 - 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.
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.
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.
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.
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.
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 - 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.
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.
Interventions
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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.
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.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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 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.
18 Years
60 Years
ALL
Yes
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Phoenix, Arizona, United States
GSK Investigational Site
Wichita, Kansas, United States
GSK Investigational Site
Kansas City, Missouri, United States
GSK Investigational Site
Rochester, New York, United States
GSK Investigational Site
Richmond, Virginia, United States
GSK Investigational Site
Seattle, Washington, United States
GSK Investigational Site
Darlinghurst, New South Wales, Australia
GSK Investigational Site
Sydney, New South Wales, Australia
GSK Investigational Site
Antwerp, , Belgium
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Edegem, , Belgium
GSK Investigational Site
Ghent, , Belgium
GSK Investigational Site
Montreal, Quebec, Canada
GSK Investigational Site
Tartu, , Estonia
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Berlin, , Germany
GSK Investigational Site
Bochum, , Germany
GSK Investigational Site
Cologne, , Germany
GSK Investigational Site
Frankfurt, , Germany
GSK Investigational Site
Hamburg, , Germany
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Barcelona, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Madrid, , Spain
GSK Investigational Site
Marbella, , Spain
GSK Investigational Site
Brighton, , United Kingdom
GSK Investigational Site
Liverpool, , United Kingdom
GSK Investigational Site
London, , United Kingdom
GSK Investigational Site
Southampton, , United Kingdom
Countries
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Other Identifiers
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2021-003586-35
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
215336
Identifier Type: -
Identifier Source: org_study_id
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