GSK Herpes Simplex Virus Immunotherapy (GSK3943104A)

GlaxoSmithKline plc. (GSK) Herpes Simplex Virus (HSV) targeted immunotherapy (HSVTI) is conducting a phase 1/2 clinical study (GSK Study ID: 215336) of a targeted immunotherapy (GSK3943104A) against HSV. This study's phases are being undertaken in the United States and Europe and include healthy participants aged 18-40 years or participants aged 18-60 years with recurrent genital herpes. This first-time-in-human (FTiH) study, involving 332 participants, aims to evaluate the reactogenicity, safety, immune response, and efficacy of an investigational HSV-targeted immunotherapy (TI). 

A trial is a combined phase I/II proof-of-concept study to assess the potential clinical efficacy of GSK3943104. Results show that GSK3943104 did not meet the study’s primary efficacy objective. This vaccine candidate, therefore, will not progress to phase III studies. No safety concern was observed. The TH HSV REC-003 study will continue for routine safety monitoring and to generate follow-up data that could offer valuable insights into recurrent genital herpes. GSK is working closely with investigators to inform trial participants. The GSK study was terminated in September 2024.

GSK terminated a SAM-based herpes vaccine approach, GSK4108771A, in 2021.

GlaxoSmithKline plc. is a global biopharma company with a purpose to unite science, technology, and talent to get ahead of disease together. GSK is headquartered in Brentford, Middlesex, the UK.

GSK Herpes Simplex Virus Immunotherapy (GSK3943104A) Indication

Genital herpes is a sexually transmitted infection (STI) passed on through vaginal, anal and oral sex. There's no cure for genital herpes. Symptoms typically clear up on their own, but the blisters can recur (resulting in an outbreak or recurrence).

GlobalData Assesses GSK-3943104A

The GlobalData report assesses how GSK-3943104A’s drug-specific phase transition success rate and Likelihood of Approval scores compare to the indication benchmarks. The Likelihood of Approval data is updated regularly based on events that impact the clinical development process and regulatory considerations. 

GSK Herpes Simplex Virus Targeted Immunotherapy Clinical Studies

GSK Study ID: 215336; March 2022 to May 2026 - Phase 1/2 clinical trial: EudraCT Number: 2021-003586-35; ClinicalTrials.gov Identifier: NCT05298254.