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Also known as Non-adjuvanted HSV formulation 1
Non-adjuvanted HSV · 1 trial · 1 indication
The solicited administration site events are pain, redness and swelling.
The solicited systemic events are fever, fatigue, headache, myalgia and arthralgia. The preferred location for measuring temperature is the oral cavity. Fever is defined as temperature equal to or above (≥) 38.0 degree Celsius (°C)/ 100.4 degree Fahrenheit (°F), regardless the location of measurement.
An unsolicited AE is any AE reported in addition to those solicited during the clinical study. Also, any 'solicited' symptom with onset outside the specified period of follow-up for solicited symptoms (7 days after each dose) is reported as an unsolicited AE.
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 neurologic disorders of interest which may or may not have an autoimmune aetiology.
Clinically significant haematological and biochemical abnormal laboratory findings are those which are not associated with an underlying disease, unless judged by the investigator to be more severe than expected for the participant's condition.
A suspected RGH episode will be classified as confirmed HSV-2 RGH episode if at least one of the lesional or anogenital swabs taken during the concerned episode is positive for HSV-2 as measured by PCR. The end of RGH reporting can occur at Day 209 for participants who have not yet completed Visit 8 \[Day 209\] at the time the Informed Consent Form (ICF) addendum was signed and consented, or at non-scheduled time, being defined by the date on which participants decided to stop the RGH reporting after acknowledgement of unsuccessful primary analysis before ICF addendum consent or the day the eDiary is deactivated after ICF addendum consent.
| Arm | Type | Description |
|---|---|---|
| Non-adjuvanted HSV formulation 1 - Part I Group | EXPERIMENTAL | Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 1 vaccine, one at Day 1 and one at Day 29. |
| Non-adjuvanted HSV formulation 2 - Part I Group | EXPERIMENTAL | Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 2 vaccine, one at Day 1 and one at Day 29. |
| Non-adjuvanted HSV formulation 3 - Part I Group | EXPERIMENTAL | Participants enrolled in Part I of the study who receive 2 doses of the non-adjuvanted HSV formulation 3 vaccine, one at Day 1 and one at Day 29. |
| HSV formulation 1 with adjuvant 1 - Part I Group | EXPERIMENTAL | Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 1 vaccine, one at Day 1 and one at Day 29. |
| HSV formulation 2 with adjuvant 1 - Part I Group | EXPERIMENTAL | Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 1 vaccine, one at Day 1 and one at Day 29. |
| HSV formulation 3 with adjuvant 1 - Part I Group | EXPERIMENTAL | Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 1 vaccine, one at Day 1 and one at Day 29. |
| HSV formulation 1 with adjuvant 2 - Part I Group | EXPERIMENTAL | Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 1 with adjuvant 2 vaccine, one at Day 1 and one at Day 29. |
| HSV formulation 2 with adjuvant 2 - Part I Group | EXPERIMENTAL | Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 2 with adjuvant 2 vaccine, one at Day 1 and one at Day 29. |
| HSV formulation 3 with adjuvant 2 - Part I Group | EXPERIMENTAL | Participants enrolled in Part I of the study who receive 2 doses of the HSV formulation 3 with adjuvant 2 vaccine, one at Day 1 and one at Day 29. |
| Placebo - Part I Group | PLACEBO_COMPARATOR | Participants enrolled in Part I of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29. |
| HSVTI formulation (F) 1 - Part II Group | EXPERIMENTAL | Participants enrolled in Part II of the study who receive 2 doses of the formulation of the HSVTI\_F1 selected from Part I of the study, one at Day 1 and one at Day 29. |
| HSVTI_F2 - Part II Group | EXPERIMENTAL | Participants enrolled in Part II of the study who receive 2 doses of the HSVTI\_F2 selected from Part I of the study, one at Day 1 and one at Day 29. |
| Placebo - Part II Group | PLACEBO_COMPARATOR | Participants enrolled in Part II of the study who receive 2 doses of Placebo, one at Day 1 and one at Day 29. |
| Name | Type | Description |
|---|---|---|
| Non-adjuvanted HSV formulation 1 | BIOLOGICAL | Two doses of the non-adjuvanted HSV formulation 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. |
| Non-adjuvanted HSV formulation 2 | BIOLOGICAL | Two doses of the non-adjuvanted HSV formulation 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. |
| Non-adjuvanted HSV formulation 3 | BIOLOGICAL | Two doses of the non-adjuvanted HSV formulation 3 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. |
| HSV formulation 1 with adjuvant 1 | BIOLOGICAL | Two doses of the HSV formulation 1 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. |
| HSV formulation 2 with adjuvant 1 | BIOLOGICAL | Two doses of the HSV formulation 2 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. |
| HSV formulation 3 with adjuvant 1 | BIOLOGICAL | Two doses of the HSV formulation 3 with adjuvant 1 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. |
| HSV formulation 1 with adjuvant 2 | BIOLOGICAL | Two doses of the HSV formulation 1 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. |
| HSV formulation 2 with adjuvant 2 | BIOLOGICAL | Two doses of the HSV formulation 2 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. |
| HSV formulation 3 with adjuvant 2 | BIOLOGICAL | Two doses of the HSV formulation 3 with adjuvant 2 vaccine administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I of the study. |
| Placebo | DRUG | Two doses of Placebo administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part I and Part II of the study. |
| HSVTI_F1 | BIOLOGICAL | Two doses of the formulation of the HSVTI\_F1 selected from Part I of the study administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part II of the study. |
| HSVTI_F2 | BIOLOGICAL | Two doses of the formulation of the HSVTI\_F2 selected from Part I of the study administered intramuscularly in the deltoid region of the non-dominant arm, one each at Day 1 and Day 29, during Part II of the study. |
Inclusion Criteria: * • Participants, who, in the opinion of the investigator, can and will comply with the requirements of the Protocol. * Written informed consent obtained from the participant prior to performance of any study-specific procedure. * Women of non-childbearing potential can be enrol...
Non-adjuvanted HSV is an investigational immunotherapy being studied for herpes simplex virus infection, including recurrent genital herpes. It is designed as a targeted immunotherapy against HSV and was evaluated in healthy participants and in adults with recurrent genital herpes. It is not an approved product.
Non-adjuvanted HSV is being developed by GSK plc, which trades under the ticker GSK. GSK sponsored the clinical study of this formulation in herpes simplex.
Non-adjuvanted HSV is in Phase 1 development. One Phase 1 trial has been completed, and no trials are currently active. The program remains investigational and has not been approved by the FDA.
Non-adjuvanted HSV was studied in NCT05298254, a completed Phase 1 trial titled a study on the reactogenicity, safety, immune response, and efficacy of a targeted immunotherapy against HSV. It enrolled 505 participants across the United States, Australia, Belgium, Canada, Estonia, Germany, Spain, and the United Kingdom.
Yes. Non-adjuvanted HSV is also known as Non-adjuvanted HSV formulation 1. Both names refer to the same GSK monoclonal antibody immunotherapy candidate being studied for herpes simplex.
The Phase 1 trial NCT05298254 was randomized, double-blind, and placebo-controlled. It enrolled 505 participants aged 18 to 40 years who were healthy, or aged 18 to 60 years with recurrent genital herpes, and included both male and female participants.