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A Phase I/II, Observer-blind, Randomised, Placebo-controlled, Multi-country Study to Evaluate Reactogenicity, Safety, Immune Response, and Efficacy of an HSV-targeted Immunotherapy in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes

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Trial Profile

A Phase I/II, Observer-blind, Randomised, Placebo-controlled, Multi-country Study to Evaluate Reactogenicity, Safety, Immune Response, and Efficacy of an HSV-targeted Immunotherapy in Healthy Participants Aged 18-40 Years or in Participants Aged 18-60 Years With Recurrent Genital Herpes

Status: Active, no longer recruiting
Phase of Trial: Phase I/II

Latest Information Update: 11 Nov 2024

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At a glance

  • Drugs GSK 4108771A (Primary)
  • Indications Herpes genitalis
  • Focus Adverse reactions; First in man; Proof of concept; Therapeutic Use
  • Acronyms TH HSV REC-003
  • Sponsors GlaxoSmithKline; GlaxoSmithKline Biologicals; GSK

Most Recent Events

  • 07 Nov 2024 Planned End Date changed from 5 Jul 2026 to 10 Jul 2025.
  • 07 Nov 2024 Planned primary completion date changed from 3 Jul 2025 to 10 Jul 2025.
  • 11 Sep 2024 According to a GSK media release, as this study did not meet the primary efficacy objective, the drug candidate will not progress to phase III studies.

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