A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years

NCT05989672 | Completed Phase 1 Results DMC

• 1 other identifier: 218459
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Herpes Simplex

Keywords

Herpes Simplex Virus genital herpes; Herpes Simplex Virus; Reactogenicity; Safety; Immune response

Outcome Measures

Primary Outcomes (15)

• Number of Participants Reporting Any Solicited Administration Site Events

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

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

• Number of Participants Reporting Any Solicited Administration Site Events

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

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

• Number of Participants Reporting Any Solicited Systemic Events

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

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

• Number of Participants Reporting Any Solicited Systemic Events

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

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

• Number of Participants Reporting Any Unsolicited Adverse Events (AEs)

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

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  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.

  At Day 57 (28 days post dose 2)

Secondary Outcomes (8)

• 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)

• 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)

• 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)

• Number of Participants Reporting Any MAEs

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

Study Arms (3)

Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI)_Formulation 1 (F1) group

EXPERIMENTAL

HSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.

Biological: HSVTI Formulation 1

HSVTI_Formulation 2 (F2) group

EXPERIMENTAL

HSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.

Biological: HSVTI Formulation 2

Placebo group

PLACEBO COMPARATOR

HSV-2 seronegative participants received placebo as control at Day 1 and Day 29.

Biological: Placebo

Interventions

HSVTI Formulation 1 BIOLOGICAL

This investigational intervention was administered intramuscularly to HSVTI\_F1 Group.

Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI)_Formulation 1 (F1) group

HSVTI Formulation 2 BIOLOGICAL

This investigational intervention was administered intramuscularly to HSVTI\_F2 Group.

HSVTI_Formulation 2 (F2) group

Placebo BIOLOGICAL

This intervention was administered intramuscularly to Placebo group.

Placebo group

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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\*\*.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Tokyo, 160-0017, Japan

Location

MeSH Terms

Conditions

Herpes Simplex

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Click here to enter text.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 4, 2023
• First Posted: August 14, 2023
• Study Start: August 8, 2023
• Primary Completion: November 29, 2023
• Study Completion: April 24, 2024
• Last Updated: June 12, 2025
• Results First Posted: June 12, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Anonymized IPD will be made available within 6 months of publication of primary, key secondary and safety results for studies in product with approved indication(s) or terminated asset(s) across all indications.
• Access Criteria: Anonymized IPD is shared with researchers whose proposals are approved by an Independent Review Panel and after a Data Sharing Agreement is in place. Access is provided for an initial period of 12 months but an extension may be granted, when justified, for up to 6 months.

Locations

JP (1)