Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
40 µg gE-gI · 1 trial · 1 indication
The solicited administration site events assessed were erythema, pain and swelling.
The solicited administration site events assessed were erythema, pain and swelling.
The solicited systemic events are fever (pyrexia), fatigue, headache, myalgia and arthralgia.
The solicited systemic events are fever (pyrexia), fatigue, headache, myalgia and arthralgia.
An unsolicited AE is an AE that was not included in a list of solicited events using an eDiary. Unsolicited events must have been spontaneously communicated by a participant who has signed the informed consent. Unsolicited AEs include both serious and non serious AEs.
An MAE is an unsolicited AE for which the participants received medical attention defined as any symptoms or illnesses requiring hospitalization, or an emergency room visit, or visit to/by healthcare professionals.
An SAE is any untoward medical occurrence that results in death, is life-threatening, requires hospitalization or prolongation of existing hospitalization, results in disability/incapacity, is a congenital anomaly/birth defect in the offspring of a study participant or results in abnormal pregnancy outcomes.
pIMDs are a subset of adverse events of special interest (AESIs) that include autoimmune diseases and other inflammatory and/or neurological disorders of interest which may or may not have an autoimmune aetiology.
The parameters reported are Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 8 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 8. Row titles indicate the participant's category at baseline and at Day 8, respectively. Categories reported when comparing baseline and Day 8 results are defined as follows: 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.
The parameters reported are Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 29 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 29. Row titles indicate the participant's category at baseline and at Day 29, respectively. Categories reported when comparing baseline and Day 29 results are defined as follows: 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.
The parameters reported are Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 36 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 36. Row titles indicate the participant's category at baseline and at Day 36, respectively. Categories reported when comparing baseline and Day 36 results are defined as follows: 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.
The parameters reported are Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 64 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 64. Row titles indicate the participant's category at baseline and at Day 64, respectively. Categories reported when comparing baseline and Day 64 results are defined as follows: 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.
The parameters reported are Alanine aminotransferase (AL), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 8 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 8. Row titles indicate the participant's category at baseline and at Day 8, respectively. Categories reported when comparing baseline and Day 8 results are defined as follows: 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.
The parameters reported are Alanine aminotransferase (AL), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 29 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 29. Row titles indicate the participant's category at baseline and at Day 29, respectively. Categories reported when comparing baseline and Day 29 results are defined as follows: 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.
The parameters reported are Alanine aminotransferase (AL), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 36 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 36. Row titles indicate the participant's category at baseline and at Day 36, respectively. Categories reported when comparing baseline and Day 36 results are defined as follows: 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.
The parameters reported are Alanine aminotransferase (AL), Aspartate aminotransferase (AST), Creatinine, Urea nitrogen, lymphocytes, neutrophils, hemoglobin, platelets, White blood cells (WBC). Results are presented as counts of participants with available baseline and Day 57 values for each laboratory parameter, summarized by shift in laboratory reference range category from baseline to Day 57. Row titles indicate the participant's category at baseline and at Day 57, respectively. Categories reported when comparing baseline and Day 57 results are defined as follows: 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.
Number of days form Day 43, defined as 14 days after administration of Dose 2 until the onset date of the first patient-reported RGH episode that is confirmed positive for HSV-2 by polymerase chain reaction (PCR) from at least one lesional or anogenital swab collected during that episode.
| Arm | Type | Description |
|---|---|---|
| Part 1: Non-adjuvanted Herpes Simplex Virus-Targeted Immunotherapy (HSVTI) (40 µg gE-gI) | EXPERIMENTAL | Healthy participants received 2 doses of the non-adjuvanted HSVTI (40 µg gE-gI), administered at Day 1 and Day 29. |
| Part 1: Non-adjuvanted HSVTI (80 µg gE-gI) | EXPERIMENTAL | Healthy participants received 2 doses of the non-adjuvanted HSVTI (80 µg gE-gI), administered at Day 1 and at Day 29. |
| Part 1: Non-adjuvanted HSVTI (160 µg gE-gI) | EXPERIMENTAL | Healthy participants received 2 doses of the non-adjuvanted HSVTI (160 µg gE-gI), administered at Day 1 and Day 29. |
| Part 1: HSVTI (40 µg gE-gI/AS01B) | EXPERIMENTAL | Healthy participants received 2 doses of HSVTI (40 µg gE-gI/AS01B), administered at Day 1 and Day 29. |
| Part 1: HSVTI (80 µg gE-gI/AS01B) | EXPERIMENTAL | Healthy participants received 2 doses of HSVTI (80 µg gE-gI/AS01B), administered at Day 1 and Day 29. |
| Part 1: HSVTI (160 µg gE-gI/AS01B) | EXPERIMENTAL | Healthy participants received 2 doses of HSVTI (160 µg gE-gI/AS01B), administered at Day 1 and Day 29. |
| Part 1: HSVTI (40 µg gE-gI/AS01E) | EXPERIMENTAL | Healthy participants received 2 doses of HSVTI (40 µg gE-gI/AS01E), administered at Day 1 and Day 29. |
| Part 1: HSVTI (80 µg gE-gI/AS01E) | EXPERIMENTAL | Healthy participants received 2 doses of HSVTI (80 µg gE-gI/AS01E), administered at Day 1 and Day 29. |
| Part 1: HSVTI (160 µg gE-gI/AS01E) | EXPERIMENTAL | Healthy participants received 2 doses of HSVTI (160 µg gE-gI/AS01E), administered at Day 1 and Day 29. |
| Part 1: Placebo | PLACEBO_COMPARATOR | Healthy participants received placebo as control at Day 1 and Day 29. |
| Part 2: HSVTI (80 µg gE-gI/AS01B) | EXPERIMENTAL | Participants with HSV-2 genital herpes received 2 doses of HSVTI (80 µg gE-gI/AS01B), administered at Day 1 and Day 29. |
| Part 2: HSVTI (80 µg gE-gI/AS01E) | EXPERIMENTAL | Participants with HSV-2 genital herpes received 2 doses of HSVTI (80 µg gE-gI/AS01E), administered at Day 1 and Day 29. |
| Part 2: Placebo | PLACEBO_COMPARATOR | Participants with HSV-2 genital herpes received placebo as control, at Day 1 and Day 29. |
| Name | Type | Description |
|---|---|---|
| 40 µg gE-gI | BIOLOGICAL | Two doses of the non-adjuvanted HSVTI (40 µg gE-gI), administered at Day 1 and Day 29. |
| 80 µg gE-gI | BIOLOGICAL | Two doses of the non-adjuvanted HSVTI (80 µg gE-gI), administered at Day 1 and at Day 2 |
| 160 µg gE-gI | BIOLOGICAL | Two doses of the non-adjuvanted HSVTI (160 µg gE-gI), administered at Day 1 and Day 29. |
| 40 µg gE-gI/AS01B | BIOLOGICAL | Two doses of HSVTI (40 µg gE-gI/AS01B), administered at Day 1 and Day 29. |
| 80 µg gE-gI/AS01B | BIOLOGICAL | Two doses of HSVTI (80 µg gE-gI/AS01B), administered at Day 1 and Day 29. |
| 60 µg gE-gI/AS01B | BIOLOGICAL | Two doses of HSVTI (160 µg gE-gI/AS01B), administered at Day 1 and Day 29. |
| 40 µg gE-gI/AS01E | BIOLOGICAL | Two doses of HSVTI (40 µg gE-gI/AS01E), administered at Day 1 and Day 29. |
| 80 µg gE-gI/AS01E | BIOLOGICAL | Two doses of HSVTI (80 µg gE-gI/AS01E), administered at Day 1 and Day 29. |
| 160 µg gE-gI/AS01E | BIOLOGICAL | Two doses of HSVTI (160 µg gE-gI/AS01E), administered at Day 1 and Day 29. |
| Placebo | DRUG | Two doses of Placebo administered on Day 1 and Day 29. |
Inclusion Criteria: 1. Participants, who, in the opinion of the investigator, can and will comply with the requirements of the Protocol. 2. Written informed consent obtained from the participant prior to performance of any study-specific procedure. 3. Women of non-childbearing potential can be enro...
40 µg gE-gI is an investigational biologic developed by GSK plc for herpes simplex. It is a targeted immunotherapy studied for its reactogenicity, safety, immune response, and efficacy against HSV. The candidate has been evaluated in a Phase 1/2 clinical trial in healthy participants and in participants with recurrent genital herpes.
40 µg gE-gI is being studied for herpes simplex, including recurrent genital herpes. Its Phase 1/2 trial enrolled healthy participants aged 18 to 40 years and participants aged 18 to 60 years with recurrent genital herpes, assessing reactogenicity, safety, immune response, and efficacy against HSV.
40 µg gE-gI is being developed by GSK plc, which trades under the ticker GSK. GSK sponsored the Phase 1/2 study of the candidate in herpes simplex, conducted across the United States, Australia, Belgium, Canada, Estonia, Germany, Spain, and the United Kingdom.
40 µg gE-gI is in Phase 1/2 development. It is an investigational candidate and is not described as approved. Its single registered trial, NCT05298254, has been completed, and no trials are currently listed as active.
40 µg gE-gI has been studied in trial NCT05298254, a completed Phase 1/2 study of reactogenicity, safety, immune response, and efficacy against HSV. The randomized, double-blind, placebo-controlled trial enrolled 504 participants across eight countries, including healthy volunteers and people with recurrent genital herpes.
Yes. Trial NCT05298254 of 40 µg gE-gI was randomized, double-blind, and placebo-controlled. It enrolled 504 participants aged 18 years and older, including healthy volunteers and participants with recurrent genital herpes, and evaluated reactogenicity, safety, immune response, and efficacy against HSV.