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HSVTI Formulation 1

Phase 1

Herpes Simplex | Monoclonal antibody | Infectious Disease |GSK plc|Last Updated: Jun 12, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
RandomizedDouble-BlindPLACEBO_CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment50
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05989672A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 YearsPHASE1 COMPLETED 50Aug 8, 2023Apr 24, 2024Jun 12, 20251 Japan
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Study Endpoints
Primary Endpoints
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.

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.

Secondary Endpoints
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)
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Study Design & Arms
AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI)_Formulation 1 (F1) groupEXPERIMENTALHSV-2 seronegative participants received HSVTI Formulation 1 (high dose) as the study intervention at Day 1 and Day 29.
HSVTI_Formulation 2 (F2) groupEXPERIMENTALHSV-2 seronegative participants received HSVTI Formulation 2 (low dose) as the study intervention at Day 1 and Day 29.
Placebo groupPLACEBO_COMPARATORHSV-2 seronegative participants received placebo as control at Day 1 and Day 29.
Interventions
NameTypeDescription
HSVTI Formulation 1BIOLOGICALThis investigational intervention was administered intramuscularly to HSVTI\_F1 Group.
HSVTI Formulation 2BIOLOGICALThis investigational intervention was administered intramuscularly to HSVTI\_F2 Group.
PlaceboBIOLOGICALThis intervention was administered intramuscularly to Placebo group.
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Eligibility Criteria
Age Range18 Years — 40 Years
SexALL
Healthy VolunteersYes
Study Sites1

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-speci...

Countries:Japan
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