GSK Herpes Simplex Virus Targeted Immunotherapy (GSK3943104A) Dosage, News, Side Effects, Usage
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 conducted 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 with 332 participants aims to evaluate the reactogenicity, safety, immune response, and efficacy of an investigational HSV-targeted immunotherapy (TI). The GSK study will be conducted in two parts: Part I assesses different formulations of the HSVTI in healthy participants; Part II assesses the two formulations of the HSVTI in participants aged 18-60 years with recurrent genital herpes.
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 Targeted Immunotherapy (GSK3943104A) Study Formulations
GSK is exploring different formulations of a potential adjuvanted subunit therapeutic approach.
Biological/Vaccine: Non-adjuvanted HSV formulation 1
Biological/Vaccine: Non-adjuvanted HSV formulation 2
Biological/Vaccine: Non-adjuvanted HSV formulation 3
Biological/Vaccine: HSV formulation 1 with adjuvant 1
Biological/Vaccine: HSV formulation 2 with adjuvant 1
Biological/Vaccine: HSV formulation 3 with adjuvant 1
Biological/Vaccine: HSV formulation 1 with adjuvant 2
Biological/Vaccine: HSV formulation 2 with adjuvant 2
Biological/Vaccine: HSV formulation 3 with adjuvant 2
Drug: Placebo
Drug: Placebo
Biological/Vaccine: HSVTI_F1
Biological/Vaccine: HSVTI_F2
GSK Herpes Simplex Virus Targeted 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 clear up themselves, but the blisters can come back (an outbreak or recurrence).
GlobalData Assesses GSK-3943104A
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 take place 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