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Also known as HSVTI Formulation 1
HSVTI · 1 trial · 1 indication
The solicited administration site events include erythema (redness), pain and swelling. Any solicited administration site AEs = occurrence of the symptom regardless of intensity grade.
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.
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.
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.
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.
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.
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| 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. |
| 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. |
| Placebo group | PLACEBO_COMPARATOR | HSV-2 seronegative participants received placebo as control at Day 1 and Day 29. |
| Name | Type | Description |
|---|---|---|
| HSVTI Formulation 1 | BIOLOGICAL | This investigational intervention was administered intramuscularly to HSVTI\_F1 Group. |
| HSVTI Formulation 2 | BIOLOGICAL | This investigational intervention was administered intramuscularly to HSVTI\_F2 Group. |
| Placebo | BIOLOGICAL | This intervention was administered intramuscularly to Placebo group. |
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...
HSVTI is an investigational monoclonal antibody developed by GSK plc for herpes simplex virus infection. It is designed as a targeted immunotherapy against HSV and has been studied in healthy adult volunteers. HSVTI is also known as HSVTI Formulation 1. It remains in early clinical development and is not an approved treatment.
HSVTI is being developed for herpes simplex, the viral infection caused by herpes simplex virus. The clinical work to date has been in healthy volunteers rather than in patients with active infection, so its intended use in herpes simplex is still under investigation. It is not approved for any indication.
GSK plc, which trades under the ticker GSK, is the developer of HSVTI. The company sponsored the Phase 1 study of the monoclonal antibody in healthy Japanese participants. GSK holds the program as part of its infectious disease pipeline.
HSVTI is in Phase 1 clinical development. One Phase 1 trial has been completed, and no trials are currently active. Because it is still investigational, HSVTI is not FDA approved, and no regulatory submission or approval has been announced for the program.
HSVTI has been evaluated in one completed Phase 1 trial, NCT05989672, titled a study on the reactogenicity, safety and immune response of a targeted immunotherapy against HSV in healthy Japanese participants aged 18 to 40 years. The trial enrolled 50 participants in Japan, was randomized, double blind, and placebo controlled.
Yes, HSVTI Formulation 1 is another name for HSVTI, the monoclonal antibody being developed by GSK plc for herpes simplex. Both names refer to the same investigational asset studied in the completed Phase 1 trial NCT05989672 in healthy Japanese volunteers.