Full name
A Phase I/II, Observer-blind, Randomised, Placebo-controlled, Multi-country Study to Evaluate Reactogenicity, Safety, Immune Response, and Efficacy of an HSV-targeted Immunotherapy in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes
NCT Number
NCT05298254
Geography
US
Non-US
Locations
Australia, Belgium, Canada, Estonia, Germany, Spain, United Kingdom, United States
Primary Endpoints
- Percentage of participants reporting each solicited administration site event. Within 7 days after the first study intervention dose (administered at Day 1)
- Percentage of participants reporting each solicited administration site event. Within 7 days after the second study intervention dose (administered at Day 29)
- Percentage of participants reporting each solicited systemic event. Within 7 days after the first study intervention dose (administered at Day 1)
- Percentage of participants reporting each solicited systemic event. Within 7 days after the second study intervention dose (administered at Day 29)
- Percentage of participants reporting unsolicited adverse events (AEs). Within 28 days after the first study intervention dose (administered at Day 1)
- Percentage of participants reporting unsolicited adverse events (AEs). Within 28 days after the second study intervention dose (administered at Day 29)
- Percentage of participants reporting medically attended events (MAEs). From Dose 1 (Day 1) up 12 months after last study intervention administration (Day 394)
- Percentage of participants reporting any serious adverse events (SAEs). From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394)
- Percentage of participants reporting any potential immune-mediated disease (pIMDs) (classified as newly diagnosed or exacerbation of pre-existing events). From Dose 1 (Day 1) up to 12 months after last study intervention administration (Day 394)
- Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part I of the study. At pre-study intervention administration (Day 1)
- Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part I of the study. At Day 8
- Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in Part I of the study. At Day 29
- Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part I of the study. At Day 36
- Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 64 in Part I of the study. At Day 64
- Percentage of participants reporting any haematological and biochemical laboratory abnormalities at pre-study intervention administration (Day 1) in Part II of the study. At pre-study intervention administration (Day 1)
- Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 8 in Part II of the study. At Day 8
- Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 29 in part II of the study. At Day 29
- Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 36 in Part II of the study. At Day 36
- Percentage of participants reporting any haematological and biochemical laboratory abnormalities at Day 57 in Part II of the study. At Day 57
- Time-to-first confirmed HSV-2 RGH episode in Part II of the study. 14 days post-Dose 2 (Day 43) to Day 759
External Link
https://clinicaltrials.gov/study/NCT05298254
Order
0
Disease
Version
Phase
1/2