Last reviewed · How we verify
NCT04762511
A Study on the Reactogenicity, Safety and Immune Response of a Vaccine Against Herpes Simplex Virus (HSV)-2 in Healthy Participants Aged 18-40 Years
Phase 1 trial testing Lower dose formulation of HSV vaccine (GSK4108771A) in Herpes Simplex in 17 participants. Terminated before completion.
26 May 2021
Quick facts
| Lead sponsor | GlaxoSmithKline |
|---|---|
| Phase | Phase 1 |
| Status | Terminated |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | treatment |
| Enrollment | 17 |
| Start date | 2 March 2021 |
| Primary completion | 26 May 2021 |
| Estimated completion | 26 May 2021 |
| Sites | 2 locations across United States |
Drugs / interventions tested
- Lower dose formulation of HSV vaccine (GSK4108771A) — full drug profile →
- Low dose formulation of HSV vaccine (GSK4108771A) — full drug profile →
- Medium dose formulation of HSV vaccine (GSK4108771A) — full drug profile →
- High dose formulation of HSV vaccine (GSK4108771A) — full drug profile →
- Placebo (saline)
Conditions studied
- Herpes Simplex — all drugs for Herpes Simplex →
Sponsor
GlaxoSmithKline — full company profile →
Who can join
Adults 18 to 40, any sex, with Herpes Simplex. Patients with the condition only — healthy volunteers not accepted.
Sponsor's own description
The purpose of this first-time-in-human (FTiH) study is to assess the reactogenicity, safety and immunogenicity of four different dose levels of an experimental herpes simplex virus type 2 (HSV-2) vaccine, when administered intramuscularly (IM) on a 0, 2-month schedule to healthy participants aged 18-40 years.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
-
Next generation self-replicating RNA vectors for vaccines and immunotherapies.
Aliahmad P, Miyake-Stoner SJ, Geall AJ, Wang NS. · · 2023 · cited 34× · PMID 35194198 · DOI 10.1038/s41417-022-00435-8 -
A review of HSV pathogenesis, vaccine development, and advanced applications.
Bai L, Xu J, Zeng L, Zhang L, et al · · 2024 · cited 30× · PMID 39207577 · DOI 10.1186/s43556-024-00199-7
Verify or expand the search:
- PubMed search for NCT04762511
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other recruiting trials for Herpes Simplex
Currently open trials in the same condition.
- NCT04065971 — Randomized, Placebo-controlled, Double-blind Study of 2LHERP® in Orofacial Herpes Infections. · Phase 4 · recruiting
Other GlaxoSmithKline trials
Trials by the same sponsor.
- NCT07569081 — A Study Evaluating the Efficacy and Safety of Momelotinib in Participants With Vacuoles, E1-enzyme, X-linked, Autoinflam · Phase 2, PHASE3 · not yet recruiting
- NCT07406347 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Infants Receiving 3-dose · Phase 1 · not yet recruiting
- NCT07286266 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Platinum-resistant Ovarian Cancer (BEH · Phase 3 · not yet recruiting
- NCT07286331 — A Study to Investigate GSK5733584 Compared With Chemotherapy in Participants With Recurrent Endometrial Cancer (BEHOLD-E · Phase 3 · not yet recruiting
- NCT07406334 — A Trial to Evaluate the Safety and Reactogenicity of an Investigational Pneumococcal Vaccine in Toddlers 12 to 15 Months · Phase 1 · not yet recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04762511 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by GlaxoSmithKline
- Last refreshed: 28 June 2021
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04762511.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing