A Study on the Reactogenicity, Safety and Immune Response... | NCT05989672

Label	Type	Description	Intervention Names
Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI)_Formulation 1 (F1) group	Experimental	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.	Biological: HSVTI Formulation 1
HSVTI_Formulation 2 (F2) group	Experimental	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.	Biological: HSVTI Formulation 2
Placebo group	Placebo Comparator	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.	Biological: Placebo

Name	Type	Description	Arm Group Labels	Other Names
HSVTI Formulation 1	Biological	This investigational intervention was administered intramuscularly to HSVTI_F1 Group.	Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI)_Formulation 1 (F1) group

Measure	Description	Time Frame
Number of Participants Reporting Any Solicited Administration Site Events	The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.	During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants Reporting Any Solicited Administration Site Events	The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.	During the 7 days (including the day of vaccination) following vaccination at Day 29
Number of Participants Reporting Any Solicited Systemic Events	The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever [temperature >=38.0-degree Celsius (°C)]. Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.	During the 7 days (including the day of vaccination) following vaccination at Day 1
Number of Participants Reporting Any Solicited Systemic Events	The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever (temperature >= 38.0 °C). Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.	During the 7 days (including the day of vaccination) following vaccination at Day 29
Number of Participants Reporting Any Unsolicited Adverse Events (AEs)	An unsolicited AE is an AE that was not included in the list of solicited events. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade.

Measure	Description	Time Frame
Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody	The seropositivity rate of anti-HSVTI antibody was assessed by Enzyme-Linked Immunosorbent Assay (ELISA) and measured in ELISA Units per milliliter (EU/mL).	At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

• Participants who, in the opinion of the investigator, can and will comply with the requirements of the protocol (e.g., completion of the diary cards, return for follow-up visits).

Written informed consent obtained from the participant prior to performance of any study-specific procedure.
Healthy participants as established by medical history and physical examination, at the discretion of the investigator, before entering into the study.
Man or woman aged 18 to 40 years, included, at the time of screening.
Japanese ethnic origin (defined as having been born in Japan with 4 ethnic Japanese grandparents and able to speak Japanese).
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 1 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 Day 118, approximately 3 months post-Dose 2.

Blood sample for simultaneous FSH and estradiol levels may be collected and tested locally at the discretion of the investigator to confirm non-reproductive potential according to local laboratory reference range.

• Seronegative for HSV-2 as determined by Western blot performed at the Screening visit.

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.
- Clinically significant abnormalities may include but are not limited to: evidence of cardiac damage, heart failure categorized as class II or greater according to the New York Heart Association functional classification, heart valve disease, pulmonary uncontrolled persistent asthma despite treatment, uncontrolled diabetes, or disease or disorder that may put the participant at risk or influence study results.
- Participants with a controlled underlying chronic co-morbidity may be enrolled, provided there have been no changes to their medication within 3 months prior to the Screening visit.
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 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 or documented or suspected HIV infection, based on medical history and physical examination (no laboratory testing required).

Hypersensitivity to latex.

Recurrent history of or uncontrolled neurological disorders or seizures.
At the screening visit: hematological parameters (hemoglobin level, white blood cell, platelet) and/or biochemical parameters (ALT, AST, creatinine, blood urea nitrogen) outside the normal laboratory ranges, unless the laboratory abnormalities are considered not clinically significant by the investigator.
Body mass index =18 kg/m2 or =35 kg/m2.
History of any form of ocular HSV infection, HSV-related erythema multiforme, or HSV-related neurological complications (including meningitis, encephalitis, radiculopathy, myelitis).

Prior/Concomitant therapy:

Use of any investigational or non-registered product (drug, vaccine or invasive medical device) other than the study intervention during the period beginning as of the Screening visit, or their planned use during the study period.
Planned administration or administration of a vaccine* in the period starting 15 days* before each dose and ending 15 days* after each dose of study intervention administration**.

* In case of adjuvanted and live-attenuated vaccines, this time window is to be increased to 30 days before and after each dose.
- In case emergency mass vaccination for an unforeseen public health threat (e.g., a pandemic) is recommended and/or organized by public health authorities outside the routine immunization program, the time period described above can be reduced if, necessary for that vaccine, provided it is used according to the local governmental recommendations and that the Sponsor is notified accordingly.
Administration or planned administration of long-acting immune-modifying drugs at any time during the study period (e.g., infliximab).
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 (defined as more than 14 days in total) 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 for adult participants. Inhaled, intra articular and topical steroids are allowed.
Prior receipt of a vaccine containing HSV antigens.

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 (drug or invasive medical device).

Other exclusions:

• Pregnant or lactating woman. Woman planning to become pregnant or planning to discontinue contraceptive precautions before Day 118 (approximately 3 months post-Dose 2).

Facility	Status	City	State	ZIP	Country	Contacts
GSK Investigational Site		Tokyo		160-0017	Japan

ID	Title	Description
FG000	Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI)_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
FG001	HSVTI_F2 Group

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Mar 20, 2023	Apr 22, 2025

ID	Title	Description
BG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
BG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
BG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
BG003	Total	Total of all reporting groups

Units	Counts
Participants	BG00020 BG00120 BG00210 BG00350

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

Number of Participants Reporting Any Solicited Administration Site Events

The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.

Analysis was performed on the Exposed set (ES), which included all participants who received at least one dose of the study intervention and have post-vaccination data for the specified analysis at specified timepoints.

Posted

Count of Participants

Participants

During the 7 days (including the day of vaccination) following vaccination at Day 1

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Units	Counts
Participants	OG00020 OG00120 OG00210

Title

Denominators

Categories

Erythema

Title	Measurements
	OG0008 OG0012 OG0020

Pain

Primary

Number of Participants Reporting Any Solicited Administration Site Events

The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

During the 7 days (including the day of vaccination) following vaccination at Day 29

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Units

Primary

Number of Participants Reporting Any Solicited Systemic Events

The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever [temperature >=38.0-degree Celsius (°C)]. Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

During the 7 days (including the day of vaccination) following vaccination at Day 1

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Primary

Number of Participants Reporting Any Solicited Systemic Events

The solicited systemic events include arthralgia (joint pain), fatigue (tiredness), headache, myalgia (muscle pain), and fever (temperature >= 38.0 °C). Any solicited systemic AEs = occurrence of the symptom regardless of intensity grade.

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

During the 7 days (including the day of vaccination) following vaccination at Day 29

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Primary

Number of Participants Reporting Any Unsolicited Adverse Events (AEs)

An unsolicited AE is an AE that was not included in the list of solicited events. Also, any solicited symptom with onset outside the specified period of follow-up for solicited symptoms is to be reported as an unsolicited AE. Any = occurrence of the symptom regardless of intensity grade.

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

During the 28 days (including the day of vaccination) following vaccination at Day 1

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Primary

Number of Participants Reporting Any Unsolicited AEs

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

During the 28 days (including the day of vaccination) following vaccination at Day 29

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Primary

Number of Participants Reporting Any Medically Attended Events (MAEs)

MAEs are defined as AEs requiring medically attended visits, such as visits for hospitalization, an emergency room visit, or an otherwise unscheduled visit to or from medical personnel (medical doctor) for any reason. Any = occurrence of the symptom regardless of intensity grade.

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

From Day 1 (dose 1) up to Day 57 (28 days post dose 2)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Primary

Number of Participants Reporting Any Serious Adverse Events (SAEs)

An SAE is defined as any untoward medical occurrence that: resulted in death, was life threatening, required hospitalization or prolongation of hospitalization, resulted in disability/incapacity or was a congenital anomaly/birth defect in the offspring of a study subject. Any = occurrence of the symptom regardless of intensity grade.

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

From Day 1 (dose 1) up to Day 57 (28 days post dose 2)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Primary

Number of Participants Reporting Any Newly Diagnosed Potential Immune-Mediated Diseases (pIMDs)

plMDs are defined as a subset of adverse events of special interest (AESI) that include autoimmune diseases and other inflammatory or neurologic disorders that may or may not have an autoimmune etiology. Newly diagnosed pIMDs are categorized as new-onset conditions if they start following the administration of the study intervention. Any = occurrence of the symptom regardless of intensity grade.

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

From Day 1 (dose 1) up to Day 57 (28 days post dose 2)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Primary

Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs

Exacerbation of pre-existing pIMDs is categorized as an exacerbation of a pre-existing chronic condition if the condition worsened following the administration of the study intervention.

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

From Day 1 (dose 1) up to Day 57 (28 days post dose 2)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Units	Counts

Primary

Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities

The safety laboratory data included haematological parameters (hemoglobin, white blood cells (WBC), platelets), and chemical parameters (Alanine Aminotransferase [ALT], Aspartate Aminotransferase [AST], Creatinine, Urea nitrogen). Below = value below the laboratory reference range defined for the specified visit and laboratory parameter; Within = value within the laboratory reference range defined for the specified visit and laboratory parameter; Above = value above the laboratory reference range defined for the specified visit and laboratory parameter.

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

At Day 1 (pre-study intervention administration)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group

Primary

Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

At Day 8 (7 days post dose 1)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Primary

Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

At Day 29 (28 days post dose 1)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Primary

Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

At Day 36 (7 days post dose 2)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Primary

Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

At Day 57 (28 days post dose 2)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Secondary

Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody

The seropositivity rate of anti-HSVTI antibody was assessed by Enzyme-Linked Immunosorbent Assay (ELISA) and measured in ELISA Units per milliliter (EU/mL).

Analysis was performed on the Per Protocol set for analysis of humoral immunogenicity (PPS_Immuno) which included all participants who received all doses as per protocol, have immunogenicity results post-dose, complied with dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity, without prohibited concomitant medication/vaccination and have post-vaccination data for the specified analysis at specified timepoints.

Posted

Number

95% Confidence Interval

Percentage of participants

At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group

Secondary

Anti-HSVTI Antibody Geometric Mean Concentration (GMC)

Analysis was performed on the PPS_Immuno. Only participants with data available at specified timepoints were included in the analysis.

Posted

Geometric Mean

95% Confidence Interval

EU/mL

At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Units	Counts
Participants

Secondary

Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency

The geometric mean of HSVTI CD4+T cells frequency expressing at least 2 markers including at least one cytokine among Interferon [IFN]-gamma, Tumour necrosis factor [TNF]-alpha, Interleukin [IL]-2, IL-13, IL-17, 4-1BB and CD40L were assessed by Intracellular staining (ICS).

Analysis was performed on the Per Protocol set for analysis of cellular immunogenicity (PPS_CMI) which included all participants who received all doses as per protocol, have CMI results post-dose, complied with dosing/blood draw intervals, without intercurrent conditions that may interfere with immunogenicity, without prohibited concomitant medication/vaccination and have post-vaccination data for the specified analysis at specified timepoints.

Posted

Geometric Mean

Standard Deviation

HSVTI-specifc CD4+ T cells/10^6 cells

At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002

Secondary

Geometric Mean of HSVTI-specific CD8+ T Cells Frequency

The geometric mean of HSVTI CD8+ T cells frequency expressing at least 2 activation markers including at least one cytokine among IFN-gamma, TNF-alpha, IL-2, IL-13, IL- 17, 4-1BB and CD40L were assessed by ICS.

Analysis was performed on the PPS_CMI. Only participants with data available at specified timepoints were included in the analysis.

Posted

Geometric Mean

Standard Deviation

HSVTI-specifc CD8+ T cells/10^6 cells

At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Secondary

Number of Participants Reporting Any MAEs

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

From Day 1 (dose 1) up to study end (Day 209)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Units	Counts
Participants	OG000

Secondary

Number of Participants Reporting Any SAEs

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

From Day 1 (dose 1) up to study end (Day 209)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Units	Counts
Participants	OG000

Secondary

Number of Participants Reporting Any Newly Diagnosed pIMDs

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

From Day 1 (dose 1) up to study end (Day 209)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Units	Counts
Participants	OG000

Secondary

Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs

Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.

Posted

Count of Participants

Participants

From Day 1 (dose 1) up to study end (Day 209)

ID	Title	Description
OG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
OG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
OG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Units	Counts
Participants

Other Adverse Events

Term	Organ System	Source Vocabulary	Assessment Type	Statistical Information
Lymph node pain	Blood and lymphatic system disorders	27.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected10 at risk
External ear pain	Ear and labyrinth disorders	27.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected10 at risk
Eye pain	Eye disorders	27.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected10 at risk
Abdominal discomfort	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected10 at risk
Dental abfraction	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected10 at risk
Parotid gland enlargement	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected10 at risk
Salivary gland pain	Gastrointestinal disorders	27.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected10 at risk
Vomiting	Gastrointestinal disorders	27.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected10 at risk
Administration site erythema	General disorders	27.0	Systematic Assessment	EG00010 events9 affected20 at risk EG0016 events4 affected20 at risk EG0020 events0 affected10 at risk
Administration site pain	General disorders	27.0	Systematic Assessment	EG00035 events19 affected20 at risk EG00132 events19 affected20 at risk EG0024 events4 affected10 at risk
Administration site pruritus	General disorders	27.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0013 events2 affected20 at risk EG0020 events0 affected10 at risk
Administration site swelling	General disorders	27.0	Systematic Assessment	EG0008 events5 affected20 at risk EG0016 events4 affected20 at risk EG0020 events0 affected10 at risk
Chills	General disorders	27.0	Systematic Assessment	EG0003 events3 affected20 at risk EG0012 events2 affected20 at risk EG0020 events0 affected10 at risk
Fatigue	General disorders	27.0	Systematic Assessment	EG00029 events18 affected20 at risk EG00113 events10 affected20 at risk EG0022 events1 affected10 at risk
Feeling hot	General disorders	27.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected10 at risk
Malaise	General disorders	27.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected10 at risk
Pyrexia	General disorders	27.0	Systematic Assessment	EG0008 events7 affected20 at risk EG0011 events1 affected20 at risk EG0022 events2 affected10 at risk
COVID-19	Infections and infestations	27.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected10 at risk
Influenza	Infections and infestations	27.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected10 at risk
Nasopharyngitis	Infections and infestations	27.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0012 events2 affected20 at risk EG0020 events0 affected10 at risk
Sinusitis	Infections and infestations	27.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected10 at risk
Arthropod sting	Injury, poisoning and procedural complications	27.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected10 at risk
Decreased appetite	Metabolism and nutrition disorders	27.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected10 at risk
Arthralgia	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG00012 events8 affected20 at risk EG0019 events5 affected20 at risk EG0020 events0 affected10 at risk
Myalgia	Musculoskeletal and connective tissue disorders	27.0	Systematic Assessment	EG00020 events15 affected20 at risk EG00113 events8 affected20 at risk EG0021 events1 affected10 at risk
Dizziness	Nervous system disorders	27.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected10 at risk
Headache	Nervous system disorders	27.0	Systematic Assessment	EG00017 events12 affected20 at risk EG0017 events6 affected20 at risk EG0023 events2 affected10 at risk
Balanoposthitis	Reproductive system and breast disorders	27.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected10 at risk
Cough	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0011 events1 affected20 at risk EG0022 events2 affected10 at risk
Nasal congestion	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0002 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected10 at risk
Oropharyngeal pain	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0010 events0 affected20 at risk EG0021 events1 affected10 at risk
Rhinorrhoea	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected10 at risk
Sneezing	Respiratory, thoracic and mediastinal disorders	27.0	Systematic Assessment	EG0000 events0 affected20 at risk EG0011 events1 affected20 at risk EG0020 events0 affected10 at risk
Dermatitis	Skin and subcutaneous tissue disorders	27.0	Systematic Assessment	EG0001 events1 affected20 at risk EG0010 events0 affected20 at risk EG0020 events0 affected10 at risk

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

ID	Title	Description	Deaths (At Risk)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	HSVTI_F1 Group	HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.	20	20	20	20
EG001	HSVTI_F2 Group	HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.	20	20	20	20
EG002	Placebo Group	HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.	10	10	8	10