Trials / Completed
CompletedNCT05989672
A Study on the Reactogenicity, Safety and Immune Response of a Targeted Immunotherapy Against HSV in Healthy Japanese Participants Aged 18-40 Years
A Phase 1, Observer-blind, Randomized, Placebo-Controlled Study to Evaluate Reactogenicity, Safety and Immune Response of an HSV-targeted Immunotherapy in HSV-2 Seronegative Japanese Participants Aged 18-40 Years
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 50 (actual)
- Sponsor
- GlaxoSmithKline · Industry
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Accepted
Summary
The purpose of this study is to evaluate the safety, reactogenicity and immunogenicity of 2 formulations of Herpes Simplex Virus (HSV)-Targeted Immunotherapy (HSVTI) in HSV-2 seronegative ethnic Japanese adults aged 18-40 years.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | HSVTI Formulation 1 | This investigational intervention was administered intramuscularly to HSVTI\_F1 Group. |
| BIOLOGICAL | HSVTI Formulation 2 | This investigational intervention was administered intramuscularly to HSVTI\_F2 Group. |
| BIOLOGICAL | Placebo | This intervention was administered intramuscularly to Placebo group. |
Timeline
- Start date
- 2023-08-08
- Primary completion
- 2023-11-29
- Completion
- 2024-04-24
- First posted
- 2023-08-14
- Last updated
- 2025-06-12
- Results posted
- 2025-06-12
Locations
1 site across 1 country: Japan
Source: ClinicalTrials.gov record NCT05989672. Inclusion in this directory is not an endorsement.