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| ID | Type | Description | Link |
|---|---|---|---|
| 2021-003586-35 | EudraCT Number |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Non-adjuvanted HSV formulation 1 - Part I Group | Experimental | 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 2 - Part I Group | Experimental | 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. |
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| Non-adjuvanted HSV formulation 3 - Part I Group | Experimental | 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. |
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| HSV formulation 1 with adjuvant 1 - Part I Group | Experimental | 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. |
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| HSV formulation 2 with adjuvant 1 - Part I Group | Experimental | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-adjuvanted HSV formulation 1 | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants reporting each solicited administration site event | The solicited administration site events are pain, redness and swelling. | Within 7 days after the first study intervention dose (administered at Day 1) |
| Percentage of participants reporting each solicited administration site event | The solicited administration site events are pain, redness and swelling. | Within 7 days after the second study intervention dose (administered at Day 29) |
| 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. | Within 7 days after the first study intervention dose (administered at Day 1) |
| 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. | Within 7 days after the second study intervention dose (administered at Day 29) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of confirmed HSV-2 RGH episodes 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. The end of RGH reporting can occur at Day 209 for participants who have not yet completed Visit 8 [Day 209] at the time the Informed Consent Form (ICF) addendum was signed and consented, or at non-scheduled time, being defined by the date on which participants decided to stop the RGH reporting after acknowledgement of unsuccessful primary analysis before ICF addendum consent or the day the eDiary is deactivated after ICF addendum consent. |
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Inclusion Criteria:
• Participants, who, in the opinion of the investigator, can and will comply with the requirements of the Protocol.
Written informed consent obtained from the participant prior to performance of any study-specific procedure.
Women of non-childbearing potential can be enrolled in the study.
Women of childbearing potential can be enrolled in the study, if the participant:
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.
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
Prior/Concomitant Therapy
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
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| Name | Affiliation | Role |
|---|---|---|
| GSK Clinical Trials | GlaxoSmithKline | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| GSK Investigational Site | Phoenix | Arizona | 85015 | United States | ||
| GSK Investigational Site |
Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gskstudyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf
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 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.
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Data will be collected in an observer-blind manner.
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| HSV formulation 3 with adjuvant 1 - Part I Group | Experimental | 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. |
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| HSV formulation 1 with adjuvant 2 - Part I Group | Experimental | 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. |
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| HSV formulation 2 with adjuvant 2 - Part I Group | Experimental | 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. |
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| HSV formulation 3 with adjuvant 2 - Part I Group | Experimental | 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. |
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| Placebo - Part I Group | Placebo Comparator | Participants enrolled in Part I of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29. |
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| HSVTI formulation (F) 1 - Part II Group | Experimental | 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. |
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| HSVTI_F2 - Part II Group | Experimental | 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. |
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| Placebo - Part II Group | Placebo Comparator | Participants enrolled in Part II of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29. |
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| Non-adjuvanted HSV formulation 2 | Biological | 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. |
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| Non-adjuvanted HSV formulation 3 | Biological | 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. |
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| HSV formulation 1 with adjuvant 1 | Biological | 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. |
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| HSV formulation 2 with adjuvant 1 | Biological | 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. |
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| HSV formulation 3 with adjuvant 1 | Biological | 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. |
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| HSV formulation 1 with adjuvant 2 | Biological | 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. |
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| HSV formulation 2 with adjuvant 2 | Biological | 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. |
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| HSV formulation 3 with adjuvant 2 | Biological | 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. |
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| Placebo | Drug | 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. |
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| HSVTI_F1 | Biological | 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. |
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| HSVTI_F2 | Biological | 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. |
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| Within 28 days after the first study intervention dose (administered at Day 1) |
| 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. | Within 28 days after the second study intervention dose (administered at Day 29) |
| 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. | From Dose 1 (Day 1) up 12 months after last study intervention administration (Day 394) |
| 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. | From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394) |
| 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. | From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394) |
| 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. | At pre-study intervention administration (Day 1) |
| Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part I of the study | At Day 8 |
| Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in Part I of the study | At Day 29 |
| Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part I of the study | At Day 36 |
| Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 64 in Part I of the study | At Day 64 |
| Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part II of the study | At pre-study intervention administration (Day 1) |
| Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part II of the study | At Day 8 |
| Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in part II of the study | At Day 29 |
| Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part II of the study | At Day 36 |
| Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 57 in Part II of the study | At Day 57 |
| 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. The end of RGH reporting can occur at Day 209 for participants who have not yet completed Visit 8 [Day 209] at the time the Informed Consent Form (ICF) addendum was signed and consented, or at non-scheduled time, being defined by the date on which participants decided to stop the RGH reporting after acknowledgement of unsuccessful primary analysis before ICF addendum consent or the day the eDiary is deactivated after ICF addendum consent. | 14 days post-Dose 2 (Day 43) to end of RGH event reporting period |
| 14 days post-Dose 2 (Day 43) to end of RGH event reporting period |
| Percentage of participants free from 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. | At 6 months after the last study intervention administration (Day 29) |
| Herpes Symptoms Checklist (HSC) total score during each confirmed HSV-2 RGH episode 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. The end of RGH reporting can occur at Day 209 for participants who have not yet completed Visit 8 [Day 209] at the time the Informed Consent Form (ICF) addendum was signed and consented, or at non-scheduled time, being defined by the date on which participants decided to stop the RGH reporting after acknowledgement of unsuccessful primary analysis before ICF addendum consent or the day the eDiary is deactivated after ICF addendum consent. | 14 days post-Dose 2 (Day 43) to end of RGH event reporting period |
| Number of days with RGH-associated symptoms during each confirmed HSV-2 RGH episode 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. The end of RGH reporting can occur at Day 209 for participants who have not yet completed Visit 8 [Day 209] at the time the Informed Consent Form (ICF) addendum was signed and consented, or at non-scheduled time, being defined by the date on which participants decided to stop the RGH reporting after acknowledgement of unsuccessful primary analysis before ICF addendum consent or the day the eDiary is deactivated after ICF addendum consent. | 14 days post-Dose 2 (Day 43) to end of RGH event reporting period |
| Number of days with confirmed HSV-2 genital herpes lesions 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. The end of RGH reporting can occur at Day 209 for participants who have not yet completed Visit 8 [Day 209] at the time the Informed Consent Form (ICF) addendum was signed and consented, or at non-scheduled time, being defined by the date on which participants decided to stop the RGH reporting after acknowledgement of unsuccessful primary analysis before ICF addendum consent or the day the eDiary is deactivated after ICF addendum consent. | 14 days post-Dose 2 (Day 43) to end of RGH event reporting period |
| 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. | At 6 weeks post-Dose 2 (Day 71) compared to baseline (Day -28 to Day -1) |
| Number of HSV-2 DNA shedding episodes in Part II of the study | Number of HSV-2 shedding episodes during the 28-day swabbing period. | Day -28 to Day -1 |
| Number of HSV-2 DNA shedding episodes in Part II of the study | Number of HSV-2 shedding episodes during the 28-day swabbing period. | Day 43 to Day 70 |
| Number of HSV-2 DNA shedding episodes in Part II of the study | Number of HSV-2 shedding episodes during the 28-day swabbing period. | Day 181 to Day 208 |
| Duration of HSV-2 DNA shedding episodes in Part II of the study | Number of days of a HSV-2 shedding episode. | Day -28 to Day -1 |
| Duration of HSV-2 DNA shedding episodes in Part II of the study | Number of days of a HSV-2 shedding episode. | Day 43 to Day 70 |
| Duration of HSV-2 DNA shedding episodes in Part II of the study | Number of days of a HSV-2 shedding episode. | Day 181 to Day 208 |
| Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part I of the study | At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394 |
| Anti-HSVTI antibody geometric mean concentrations (GMCs) in Part II of the study | At pre-study intervention administration (Day 1), Day 29 and Day 57 |
| Percentage of seropositive participants for anti-HSVTI antibodies in Part I of the study | At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394 |
| Percentage of seropositive participants for anti-HSVTI antibodies in Part II of the study | At pre-study intervention administration (Day 1), Day 29 and Day 57 |
| 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 | At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394 |
| 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 | At pre-study intervention administration (Day 1), Day 29 and Day 57 |
| 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 | At pre-study intervention administration (Day 1), Day 29, Day 64, Day 209 and Day 394 |
| 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 | At pre-study intervention administration (Day 1), Day 29 and Day 57 |
| Wichita |
| Kansas |
| 67207 |
| United States |
| GSK Investigational Site | Kansas City | Missouri | 64114 | United States |
| GSK Investigational Site | Rochester | New York | 14609 | United States |
| GSK Investigational Site | Richmond | Virginia | 23219 | United States |
| GSK Investigational Site | Seattle | Washington | 98105 | United States |
| GSK Investigational Site | Darlinghurst | New South Wales | 2010 | Australia |
| GSK Investigational Site | Sydney | New South Wales | 2010 | Australia |
| GSK Investigational Site | Antwerp | 2000 | Belgium |
| GSK Investigational Site | Brussels | 1000 | Belgium |
| GSK Investigational Site | Edegem | 2650 | Belgium |
| GSK Investigational Site | Ghent | 9000 | Belgium |
| GSK Investigational Site | Montreal | Quebec | H2L 4E9 | Canada |
| GSK Investigational Site | Tartu | 50106 | Estonia |
| GSK Investigational Site | Berlin | 10117 | Germany |
| GSK Investigational Site | Berlin | 10439 | Germany |
| GSK Investigational Site | Bochum | 44787 | Germany |
| GSK Investigational Site | Cologne | 50674 | Germany |
| GSK Investigational Site | Frankfurt | 60596 | Germany |
| GSK Investigational Site | Hamburg | 20146 | Germany |
| GSK Investigational Site | Barcelona | 08001 | Spain |
| GSK Investigational Site | Barcelona | 08015 | Spain |
| GSK Investigational Site | Madrid | 28010 | Spain |
| GSK Investigational Site | Madrid | 28040 | Spain |
| GSK Investigational Site | Madrid | 28222 | Spain |
| GSK Investigational Site | Marbella | 29600 | Spain |
| GSK Investigational Site | Brighton | BN2 1ES | United Kingdom |
| GSK Investigational Site | Liverpool | L7 8XP | United Kingdom |
| GSK Investigational Site | London | WC1E 6JB | United Kingdom |
| GSK Investigational Site | Southampton | SO14 0YG | United Kingdom |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Jun 11, 2026 | Jul 8, 2026 | 19 |
| ID | Term |
|---|---|
| D006561 | Herpes Simplex |
| D006558 | Herpes Genitalis |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
| D017193 | Skin Diseases, Viral |
| D012874 | Skin Diseases, Infectious |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D015229 | Sexually Transmitted Diseases, Viral |
| D012749 | Sexually Transmitted Diseases |
| D003141 | Communicable Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D005832 | Genital Diseases, Male |
| D052801 | Male Urogenital Diseases |
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