drugset / Trial / NCT05298254
A Study on the Reactogenicity, Safety, Immune Response, and Efficacy of a Targeted Immunotherapy Against HSV in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes
RandomizedParallel-groupQuadruple-blindTreatment
Summary
The purpose of this first-time-in-human (FTiH) study is to evaluate the reactogenicity, safety, immune response, and efficacy of an investigational herpes simplex virus (HSV)-targeted immunotherapy (TI). The study will be conducted in 2 parts: Part I assessing different formulations of the Herpes Simplex Virus-targeted immunotherapy (HSVTI) in healthy participants aged 18-40 years; Part II assessing the 2 formulations of the HSVTI in participants aged 18-60 years with recurrent genital herpes.
Timeline
- Start
- 2022-03-07
- Primary completion
- 2025-06-12
- Completion
- 2025-06-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | HSV formulation 1 with adjuvant 1 | Vaccine | — | Intramuscular |
| Subject | HSV formulation 1 with adjuvant 2 | Vaccine | — | Intramuscular |
| Subject | HSV formulation 2 with adjuvant 1 | Unknown | — | Intramuscular |
| Subject | HSV formulation 2 with adjuvant 2 | Vaccine | — | Intramuscular |
| Subject | HSV formulation 3 with adjuvant 1 | Vaccine | — | Intramuscular |
| Subject | HSV formulation 3 with adjuvant 2 | Vaccine | — | Intramuscular |
| Subject | HSVTI_F1 | Unknown | — | Intramuscular |
| Subject | HSVTI_F2 | Unknown | — | Intramuscular |
| Subject | Non-adjuvanted HSV formulation 1 | Vaccine | — | Intramuscular |
| Subject | Non-adjuvanted HSV formulation 2 | Vaccine | — | Intramuscular |
| Subject | Non-adjuvanted HSV formulation 3 | Vaccine | — | Intramuscular |