Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
HSVTI Formulation 1 · 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 Formulation 1 is an investigational monoclonal antibody being developed for the treatment or prevention of Herpes Simplex. It is currently in Phase 1 clinical development, meaning it has not yet been approved for use and is still being studied for safety and immune response in clinical trials.
HSVTI Formulation 1 is a monoclonal antibody designed to target Herpes Simplex virus. As a targeted immunotherapy, it is intended to elicit an immune response against the virus, although the specific molecular target has not been disclosed in available information.
HSVTI Formulation 1 is being developed by GSK plc, a global biopharmaceutical company listed on the stock exchange under the ticker symbol GSK. GSK is conducting clinical trials to evaluate the safety and immunogenicity of this investigational therapy for Herpes Simplex.
HSVTI Formulation 1 is in Phase 1 clinical development. It is an investigational drug, meaning it is not yet approved by regulatory authorities. The Phase 1 trial has been completed, and the drug is still in the early stages of clinical testing to assess its safety and immune response.
HSVTI Formulation 1 has been studied in one clinical trial, identified as NCT05989672. This Phase 1 study, titled 'A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years,' was completed and enrolled 50 participants in Japan.