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. The production process would be very similar for a wide variety of different vaccines, potentially leading to substantial streamlining of the vaccine R&D process, says GSK.
England-based 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. The GSK vaccine portfolio has been helping to protect people from serious disease for well over 100 years, with our Marietta (US) site dedicated to smallpox vaccine production since 1882.
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) News
May 5, 2021 - The U.S.-based Phase I, Single-blind, Randomised, Placebo-controlled, Dose Escalation Study to Evaluate the Reactogenicity, Safety and Immune Response of an HSV Vaccine in Healthy (~60) Participants Aged 18-40 Years, was last updated. Women of non-childbearing potential may be enrolled in the study. And women of childbearing potential may be enrolled in the study under certain conditions.
March 23, 2021 - GlaxoSmithKline (GSK) launched a limited phase 1 clinical trial for a herpes simplex virus type 2 (HSV-2) candidate known as HSV vaccine (GSK4108771A). This USA-based study will include sixty participants and was last updated on March 18, 2021. This first-time-in-human study intends to assess the reactogenicity, safety, and immunogenicity of four different dose levels of an experimental HSV-2 vaccine administered intramuscularly on a 0, 2-month schedule to healthy participants aged 18-40 years.
HSV-2 Vaccine (GSK4108771A) Clinical Trial
Clinical Trial NCT04762511: The purpose of this Phase 1 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. GSK has suspended this clinical trial to assess data that has been received.