Herpes Vaccine Candidate Launches Early-Phase Study
Massachusetts-based Rational Vaccines Inc. today announced the launch of an observational clinical trial designed to determine the baseline characteristics of patients diagnosed with recurrent symptomatic herpes simplex virus type 2 (HSV-2).
In addition to assessing the typical baseline characteristics of a population, the purpose of this study is also to determine the acceptance of clinical trial procedures and understand the interest of the target patient population to participate in a therapeutic Phase 1/2 HSV-2 vaccine study in humans.
The RVx-001-PSS vaccine candidate study, "A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease," is being conducted at Southampton University Hospital and Chelsea and Westminster Hospital London, England.
The study was launched on August 3, 2022, and intends to recruit about 200 adults.
"Patients who develop symptomatic herpetic disease suffer not only from recurrent physical symptoms but may also suffer from social stigma and isolation because the infection is usually transmitted sexually," commented Kerstin Westritschnig, M.D., chief medical officer of Rational Vaccines, in a related press release on August 15. 2022.
"There is no cure for herpes.... and there are no approved vaccines, immunotherapies, or sufficiently reliable diagnostics currently available."
"Antiviral medications developed in the 1970s can help to reduce the severity and frequency of symptoms but cannot cure the infection."
"We look forward to initiating this clinical study as these findings will help inform the design of our Phase 1/2 clinical trial, which will evaluate our lead vaccine candidate for HSV-2," added Dr. Westritschnig.
According to a 2020 report by the World Health Organization, herpes infects billions globally.
Herpes simplex virus (HSV), commonly referred to as herpes, is categorized into two types: herpes simplex virus type 1 (HSV-1) and herpes simplex virus type 2 (HSV-2).
HSV-1 is the primary cause of oral herpes but can also cause genital herpes, and HSV-2 is the primary cause of genital herpes.
In addition to the RVx201 vaccine candidate, several other vaccines are conducting clinical studies.
For example, Moderna Inc. announced earlier this year that the mRNA-1608 vaccine candidate targets HSV-2 disease.
mRNA-1608 aims to induce a strong antibody response with neutralizing and effector functionality combined with cell-mediated immunity.
As of today, the U.S. FDA has not approved any herpes vaccine. Additional herpes vaccine development news is posted at PrecisionVaccinations.com/Herpes.
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