Herpes Simplex
Conditions
Keywords
Herpes Simplex Virus genital herpes, Herpes Simplex Virus, Reactogenicity, Safety, Immune response
Brief summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI) in HSV-2 seronegative ethnic Japanese adults aged 18-40 years.
Interventions
BIOLOGICALHSVTI Formulation 1
This investigational intervention was administered intramuscularly to HSVTI\_F1 Group.
BIOLOGICALHSVTI Formulation 2
This investigational intervention was administered intramuscularly to HSVTI\_F2 Group.
BIOLOGICALPlacebo
This intervention was administered intramuscularly to Placebo group.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Masking description
Click here to enter text.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes
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).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | At Day 1 (pre-study intervention administration) | 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. |
| Number of Participants Reporting Any Solicited Administration Site Events | During the 7 days (including the day of vaccination) following vaccination at Day 1 | The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade. |
| Number of Participants Reporting Any Solicited Systemic Events | During the 7 days (including the day of vaccination) following vaccination at Day 1 | 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. |
| Number of Participants Reporting Any Unsolicited Adverse Events (AEs) | During the 28 days (including the day of vaccination) following vaccination at Day 1 | 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. |
| Number of Participants Reporting Any Unsolicited AEs | During the 28 days (including the day of vaccination) following vaccination at Day 29 | 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. |
| Number of Participants Reporting Any Medically Attended Events (MAEs) | From Day 1 (dose 1) up to Day 57 (28 days post dose 2) | 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. |
| Number of Participants Reporting Any Serious Adverse Events (SAEs) | From Day 1 (dose 1) up to Day 57 (28 days post dose 2) | 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. |
| Number of Participants Reporting Any Newly Diagnosed Potential Immune-Mediated Diseases (pIMDs) | From Day 1 (dose 1) up to Day 57 (28 days post dose 2) | 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. |
| Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs | From Day 1 (dose 1) up to Day 57 (28 days post dose 2) | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Anti-HSVTI Antibody Geometric Mean Concentration (GMC) | At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2) | — |
| Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency | At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2) | 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). |
| Geometric Mean of HSVTI-specific CD8+ T Cells Frequency | At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2) | 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. |
| Number of Participants Reporting Any MAEs | From Day 1 (dose 1) up to study end (Day 209) | — |
| Number of Participants Reporting Any SAEs | From Day 1 (dose 1) up to study end (Day 209) | — |
| Number of Participants Reporting Any Newly Diagnosed pIMDs | From Day 1 (dose 1) up to study end (Day 209) | — |
| Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs | From Day 1 (dose 1) up to study end (Day 209) | — |
| Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody | At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2) | The seropositivity rate of anti-HSVTI antibody was assessed by Enzyme-Linked Immunosorbent Assay (ELISA) and measured in ELISA Units per milliliter (EU/mL). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| HSVTI_F1 Group HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29. | 20 |
| HSVTI_F2 Group HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29. | 20 |
| Placebo Group HSV-2 seronegative participants received placebo as control at Day 1 and Day 29. | 10 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Adverse Event | 3 | 0 | 0 |
Baseline characteristics
| Characteristic | HSVTI_F1 Group | HSVTI_F2 Group | Placebo Group | Total |
|---|---|---|---|---|
| Age, Continuous | 29.9 YEARS STANDARD_DEVIATION 8 | 27.2 YEARS STANDARD_DEVIATION 6.7 | 31.4 YEARS STANDARD_DEVIATION 6.6 | 29.1 YEARS STANDARD_DEVIATION 7.3 |
| Race/Ethnicity, Customized ASIAN - JAPANESE HERITAGE | 20 Participants | 20 Participants | 10 Participants | 50 Participants |
| Sex: Female, Male Female | 11 Participants | 11 Participants | 6 Participants | 28 Participants |
| Sex: Female, Male Male | 9 Participants | 9 Participants | 4 Participants | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 20 | 0 / 20 | 0 / 10 |
| other Total, other adverse events | 20 / 20 | 20 / 20 | 8 / 10 |
| serious Total, serious adverse events | 0 / 20 | 0 / 20 | 0 / 10 |
Outcome results
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.
Time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs | 0 Participants |
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.
Time frame: At Day 1 (pre-study intervention administration)
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 20 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 12 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 8 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 2 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 18 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 20 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 20 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 1 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 19 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 20 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 2 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 18 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 3 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 17 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 1 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 19 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 8 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 8 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 2 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 2 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 0 Participants |
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.
Time frame: At Day 57 (28 days post dose 2)
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 15 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 9 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 3 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 8 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 14 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 1 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 17 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 16 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 17 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 2 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 17 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 2 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 2 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 18 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 1 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 18 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 1 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 6 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 14 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 18 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 8 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 1 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 1 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 1 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 9 Participants |
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.
Time frame: At Day 36 (7 days post dose 2)
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 11 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 15 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 6 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 1 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 1 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 2 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 1 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 15 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 17 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 17 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 17 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 2 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 14 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 19 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 1 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 2 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 18 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 4 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 16 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 2 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 18 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 9 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 2 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 1 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 8 Participants |
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.
Time frame: At Day 8 (7 days post dose 1)
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 6 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 19 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 14 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 20 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 1 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 20 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 20 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 18 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 2 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 20 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 1 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 1 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 18 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 2 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 18 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 1 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 5 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 15 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 19 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 2 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 8 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 2 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 8 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 1 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 9 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 0 Participants |
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.
Time frame: At Day 29 (28 days post dose 1)
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 16 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 1 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 17 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 8 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 1 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 9 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 16 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 17 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 1 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 15 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 17 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 1 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 0 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 1 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 19 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 1 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 1 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 19 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 5 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 15 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 20 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 19 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Within | 10 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Platelets | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Within | 9 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | AST | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Urea Nitrogen | Below | 1 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | ALT | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Below | 2 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Creatinine | Above | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | WBC | Below | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Hematological and Biochemical Laboratory Abnormalities | Hemoglobin | Within | 8 Participants |
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.
Time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Medically Attended Events (MAEs) | 1 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Medically Attended Events (MAEs) | 1 Participants |
| Placebo Group | Number of Participants Reporting Any Medically Attended Events (MAEs) | 3 Participants |
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.
Time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Newly Diagnosed Potential Immune-Mediated Diseases (pIMDs) | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Newly Diagnosed Potential Immune-Mediated Diseases (pIMDs) | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Newly Diagnosed Potential Immune-Mediated Diseases (pIMDs) | 0 Participants |
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.
Time frame: From Day 1 (dose 1) up to Day 57 (28 days post dose 2)
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Serious Adverse Events (SAEs) | 0 Participants |
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.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 1
Population: 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.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Administration Site Events | Pain | 19 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Administration Site Events | Erythema | 8 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Administration Site Events | Swelling | 4 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Administration Site Events | Pain | 18 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Administration Site Events | Erythema | 2 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Administration Site Events | Swelling | 3 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Administration Site Events | Erythema | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Administration Site Events | Swelling | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Administration Site Events | Pain | 4 Participants |
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.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 29
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Administration Site Events | Pain | 15 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Administration Site Events | Erythema | 2 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Administration Site Events | Swelling | 4 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Administration Site Events | Pain | 14 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Administration Site Events | Erythema | 4 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Administration Site Events | Swelling | 2 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Administration Site Events | Erythema | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Administration Site Events | Swelling | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Administration Site Events | Pain | 0 Participants |
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.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 29
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Systemic Events | Arthralgia | 6 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Systemic Events | Myalgia | 9 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Systemic Events | Headache | 7 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Systemic Events | Fever | 5 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Systemic Events | Fatigue | 13 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Systemic Events | Myalgia | 5 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Systemic Events | Arthralgia | 4 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Systemic Events | Fatigue | 7 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Systemic Events | Headache | 2 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Systemic Events | Fever | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Systemic Events | Fatigue | 1 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Systemic Events | Myalgia | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Systemic Events | Arthralgia | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Systemic Events | Fever | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Systemic Events | Headache | 1 Participants |
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.
Time frame: During the 7 days (including the day of vaccination) following vaccination at Day 1
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Systemic Events | Myalgia | 11 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Systemic Events | Headache | 10 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Systemic Events | Arthralgia | 6 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Systemic Events | Fatigue | 16 Participants |
| HSVTI_F1 Group | Number of Participants Reporting Any Solicited Systemic Events | Fever | 3 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Systemic Events | Headache | 5 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Systemic Events | Arthralgia | 5 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Systemic Events | Fatigue | 6 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Systemic Events | Myalgia | 8 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Solicited Systemic Events | Fever | 1 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Systemic Events | Fever | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Systemic Events | Myalgia | 1 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Systemic Events | Arthralgia | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Systemic Events | Headache | 2 Participants |
| Placebo Group | Number of Participants Reporting Any Solicited Systemic Events | Fatigue | 1 Participants |
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.
Time frame: During the 28 days (including the day of vaccination) following vaccination at Day 1
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Unsolicited Adverse Events (AEs) | 4 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Unsolicited Adverse Events (AEs) | 4 Participants |
| Placebo Group | Number of Participants Reporting Any Unsolicited Adverse Events (AEs) | 4 Participants |
Primary
Number of Participants Reporting Any Unsolicited 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.
Time frame: During the 28 days (including the day of vaccination) following vaccination at Day 29
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Unsolicited AEs | 4 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Unsolicited AEs | 3 Participants |
| Placebo Group | Number of Participants Reporting Any Unsolicited AEs | 2 Participants |
Secondary
Anti-HSVTI Antibody Geometric Mean Concentration (GMC)
Time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Population: Analysis was performed on the PPS\_Immuno. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| HSVTI_F1 Group | Anti-HSVTI Antibody Geometric Mean Concentration (GMC) | Day 29 | 270.1 EU/mL |
| HSVTI_F1 Group | Anti-HSVTI Antibody Geometric Mean Concentration (GMC) | Day 1 | 1.2 EU/mL |
| HSVTI_F1 Group | Anti-HSVTI Antibody Geometric Mean Concentration (GMC) | Day 57 | 558.8 EU/mL |
| HSVTI_F2 Group | Anti-HSVTI Antibody Geometric Mean Concentration (GMC) | Day 29 | 197.8 EU/mL |
| HSVTI_F2 Group | Anti-HSVTI Antibody Geometric Mean Concentration (GMC) | Day 1 | 1.0 EU/mL |
| HSVTI_F2 Group | Anti-HSVTI Antibody Geometric Mean Concentration (GMC) | Day 57 | 390.8 EU/mL |
| Placebo Group | Anti-HSVTI Antibody Geometric Mean Concentration (GMC) | Day 1 | 1.1 EU/mL |
| Placebo Group | Anti-HSVTI Antibody Geometric Mean Concentration (GMC) | Day 57 | 1.1 EU/mL |
| Placebo Group | Anti-HSVTI Antibody Geometric Mean Concentration (GMC) | Day 29 | 1.1 EU/mL |
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.
Time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Population: Analysis was performed on the PPS\_CMI. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| HSVTI_F1 Group | Geometric Mean of HSVTI-specific CD8+ T Cells Frequency | Day 29 | 27.1 HSVTI-specifc CD8+ T cells/10^6 cells | Standard Deviation 1 |
| HSVTI_F1 Group | Geometric Mean of HSVTI-specific CD8+ T Cells Frequency | Day 1 | 37.6 HSVTI-specifc CD8+ T cells/10^6 cells | Standard Deviation 0.8 |
| HSVTI_F1 Group | Geometric Mean of HSVTI-specific CD8+ T Cells Frequency | Day 57 | 61.0 HSVTI-specifc CD8+ T cells/10^6 cells | Standard Deviation 0.9 |
| HSVTI_F2 Group | Geometric Mean of HSVTI-specific CD8+ T Cells Frequency | Day 29 | 9.5 HSVTI-specifc CD8+ T cells/10^6 cells | Standard Deviation 0.8 |
| HSVTI_F2 Group | Geometric Mean of HSVTI-specific CD8+ T Cells Frequency | Day 1 | 19.6 HSVTI-specifc CD8+ T cells/10^6 cells | Standard Deviation 0.9 |
| HSVTI_F2 Group | Geometric Mean of HSVTI-specific CD8+ T Cells Frequency | Day 57 | 20.8 HSVTI-specifc CD8+ T cells/10^6 cells | Standard Deviation 0.8 |
| Placebo Group | Geometric Mean of HSVTI-specific CD8+ T Cells Frequency | Day 1 | 8.7 HSVTI-specifc CD8+ T cells/10^6 cells | Standard Deviation 0.8 |
| Placebo Group | Geometric Mean of HSVTI-specific CD8+ T Cells Frequency | Day 57 | 13.5 HSVTI-specifc CD8+ T cells/10^6 cells | Standard Deviation 0.9 |
| Placebo Group | Geometric Mean of HSVTI-specific CD8+ T Cells Frequency | Day 29 | 8.6 HSVTI-specifc CD8+ T cells/10^6 cells | Standard Deviation 0.7 |
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).
Time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Population: 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.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) | Dispersion |
|---|---|---|---|---|
| HSVTI_F1 Group | Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency | Day 29 | 456.8 HSVTI-specifc CD4+ T cells/10^6 cells | Standard Deviation 0.5 |
| HSVTI_F1 Group | Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency | Day 1 | 64.0 HSVTI-specifc CD4+ T cells/10^6 cells | Standard Deviation 0.9 |
| HSVTI_F1 Group | Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency | Day 57 | 5899.7 HSVTI-specifc CD4+ T cells/10^6 cells | Standard Deviation 0.4 |
| HSVTI_F2 Group | Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency | Day 29 | 199.1 HSVTI-specifc CD4+ T cells/10^6 cells | Standard Deviation 0.8 |
| HSVTI_F2 Group | Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency | Day 1 | 36.3 HSVTI-specifc CD4+ T cells/10^6 cells | Standard Deviation 1 |
| HSVTI_F2 Group | Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency | Day 57 | 2932.3 HSVTI-specifc CD4+ T cells/10^6 cells | Standard Deviation 0.4 |
| Placebo Group | Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency | Day 1 | 24.0 HSVTI-specifc CD4+ T cells/10^6 cells | Standard Deviation 0.9 |
| Placebo Group | Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency | Day 57 | 40.3 HSVTI-specifc CD4+ T cells/10^6 cells | Standard Deviation 1 |
| Placebo Group | Geometric Mean of HSVTI-specific Cluster of Differentiation (CD)4+T Cells Frequency | Day 29 | 21.1 HSVTI-specifc CD4+ T cells/10^6 cells | Standard Deviation 1.1 |
Secondary
Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs | 0 Participants |
Secondary
Number of Participants Reporting Any MAEs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any MAEs | 3 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any MAEs | 1 Participants |
| Placebo Group | Number of Participants Reporting Any MAEs | 4 Participants |
Secondary
Number of Participants Reporting Any Newly Diagnosed pIMDs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any Newly Diagnosed pIMDs | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any Newly Diagnosed pIMDs | 0 Participants |
| Placebo Group | Number of Participants Reporting Any Newly Diagnosed pIMDs | 0 Participants |
Secondary
Number of Participants Reporting Any SAEs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Population: Analysis was performed on the ES. Only participants with data available at specified timepoints were included in the analysis.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| HSVTI_F1 Group | Number of Participants Reporting Any SAEs | 0 Participants |
| HSVTI_F2 Group | Number of Participants Reporting Any SAEs | 0 Participants |
| Placebo Group | Number of Participants Reporting Any SAEs | 0 Participants |
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).
Time frame: At Day 1 (pre-study intervention administration), Day 29 (28 days post-Dose 1), and Day 57 (28 days post-Dose 2)
Population: 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.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| HSVTI_F1 Group | Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody | Day 29 | 100 Percentage of participants |
| HSVTI_F1 Group | Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody | Day 1 | 20.0 Percentage of participants |
| HSVTI_F1 Group | Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody | Day 57 | 100 Percentage of participants |
| HSVTI_F2 Group | Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody | Day 29 | 100 Percentage of participants |
| HSVTI_F2 Group | Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody | Day 1 | 25.0 Percentage of participants |
| HSVTI_F2 Group | Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody | Day 57 | 100 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody | Day 1 | 20.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody | Day 57 | 20.0 Percentage of participants |
| Placebo Group | Percentage of Participants With Seropositivity Rate of Anti-HSVTI Antibody | Day 29 | 20.0 Percentage of participants |