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NCT05298254 · ClinicalTrials.gov registry record · Phase 1
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
A Phase 1 study, sponsored by GlaxoSmithKline.
- Completed
- Registry status
- Phase 1
- Development phase
- 505
- Enrollment target
NCT05298254: Completed Phase 1 study, sponsored by GlaxoSmithKline.
NCT05298254 is a Phase 1 study that has completed, run by GlaxoSmithKline. The registered enrollment target is 505 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (742% higher). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05298254, a Phase 1 study, has completed, sponsored by GlaxoSmithKline.
- COMPLETED
- Registry status
- Phase 1
- Development phase
- 505 participants
- Enrollment target
Study 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.
Primary Outcome
The solicited administration site events are pain, redness and swelling.
Interventions
- BIOLOGICAL Non-adjuvanted HSV formulation 1
- BIOLOGICAL Non-adjuvanted HSV formulation 2
- BIOLOGICAL Non-adjuvanted HSV formulation 3
- BIOLOGICAL HSV formulation 1 with adjuvant 1
- BIOLOGICAL HSV formulation 2 with adjuvant 1
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 505 participants |
| Start Date | 2022-03-07 |
| Est. Completion | 2025-06-12 |
| Phase | Phase 1 |
What the finished NCT05298254 record still lists
NCT05298254 is an interventional study that assigns participants to a tested intervention. The registered 505 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (742% higher).
The record links to 0 conditions, and to 5 interventions - of which Non-adjuvanted HSV formulation 1 is the first listed.
NCT05298254 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05298254 about?
NCT05298254 is a clinical study titled "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". 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 Si...
What is the current status of trial NCT05298254?
This trial is currently completed. It is a Phase 1 study. The enrollment target is 505 participants. The study started on 2022-03-07. Estimated completion is 2025-06-12.
What interventions are being tested in trial NCT05298254?
The interventions under investigation include: Non-adjuvanted HSV formulation 1 (BIOLOGICAL), Non-adjuvanted HSV formulation 2 (BIOLOGICAL), Non-adjuvanted HSV formulation 3 (BIOLOGICAL), HSV formulation 1 with adjuvant 1 (BIOLOGICAL), HSV formulation 2 with adjuvant 1 (BIOLOGICAL).
Who is sponsoring clinical trial NCT05298254?
This trial is sponsored by GlaxoSmithKline, which has 1,345 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05298254's enrollment target sits among peer trials
505 44th of 2000 higher than 1,957 of 2,000 other Phase 1 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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