HSV-2 Vaccine (GSK4108771A) Description
The herpes simplex virus type 2 (HSV-2) vaccine candidate (GSK4108771A) utilizes self-amplifying messenger RNA, “SAM” technology.
To develop a SAM-based vaccine, GlaxoSmithKline (GSK) scientists designed a SAM molecule synthetically in a laboratory, using portions of the genetic code of a virus. However, in the SAM molecule, the genes linked to the virus's ability to cause infection are deleted and replaced with genes from target viruses that will produce the antigens for desired vaccines.
The transport of nascent HSV particles from neuron cell bodies into axons and along axons to axon tips in the periphery is an important component of this reactivation and reinfection. Two HSV membrane proteins, gE/gI and US9 play an essential role in these processes. Tiny balls of fat called lipid nanoparticles or LNPs will deliver the vaccine.
Using the body’s own cells to produce the vaccine means that GSK would only be producing the SAM genetic platform and its delivery systems. Volumes may be much smaller than with traditional vaccines and the production process would be very similar for a broad variety of different vaccines, potentially leading to substantial streamlining of the vaccine R&D process, says GSK.
GSK is the world’s largest vaccine company by revenue, delivering vaccines that help protect people at all stages of life. Our R&D focuses on developing vaccines against infectious diseases that combine high-medical needs and strong market potential.
HSV-2 Vaccine (GSK4108771A) Indication
HSV-2 Vaccine (GSK4108771A) is indicated to prevent HSV.
HSV-2 Vaccine (GSK4108771A) Dosage
HSV-2 Vaccine candidate (GSK4108771A) dosage is being tested in a Phase 1 clinical trial. Four doses of the formulation will be administered intramuscularly on day 1 and day 57.
Biological: Lower dose formulation of HSV vaccine (GSK4108771A)
Biological: Low dose formulation of HSV vaccine (GSK4108771A)
Biological: Medium dose formulation of HSV vaccine (GSK4108771A)
Biological: High dose formulation of HSV vaccine (GSK4108771A)
HSV-2 Vaccine (GSK4108771A) Clinical Trial
Clinical Trial NCT04762511: A Phase I, Single-blind, Randomised, Placebo-controlled, Dose Escalation Study to Evaluate the Reactogenicity, Safety and Immune Response of gE/gI SAM (LNP) Vaccine in (60) Healthy Participants Aged 18-40 Years. 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 on a 0, 2-month schedule.
First Posted: February 21, 2021; Last Update Posted: March 18, 2021; Estimated Study Completion Date: August 9, 2022