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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
50
This investigational intervention was administered intramuscularly to HSVTI\_F1 Group.
This investigational intervention was administered intramuscularly to HSVTI\_F2 Group.
This intervention was administered intramuscularly to Placebo group.
GSK Investigational Site
Tokyo, Japan
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
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
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
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
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.
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Time frame: During the 28 days (including the day of vaccination) following vaccination at Day 1
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
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
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)
Number of Participants Reporting Any MAEs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Number of Participants Reporting Any SAEs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Number of Participants Reporting Any Newly Diagnosed pIMDs
Time frame: From Day 1 (dose 1) up to study end (Day 209)
Number of Participants Reporting Any Exacerbation of Pre-existing pIMDs
Time frame: From Day 1 (dose 1) up to study end (Day 209)