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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

Terminated Phase 1 Last updated 28 June 2021
What this trial tests

Phase 1 trial testing Lower dose formulation of HSV vaccine (GSK4108771A) in Herpes Simplex in 17 participants. Terminated before completion.

Timeline
2 March 2021
Primary endpoint
26 May 2021
26 May 2021

Quick facts

Lead sponsorGlaxoSmithKline
PhasePhase 1
StatusTerminated
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposetreatment
Enrollment17
Start date2 March 2021
Primary completion26 May 2021
Estimated completion26 May 2021
Sites2 locations across United States

Drugs / interventions tested

Conditions studied

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):

  1. 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
  2. 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:

Other recruiting trials for Herpes Simplex

Currently open trials in the same condition.

Other GlaxoSmithKline trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

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.

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