Study to be conducted at two leading research institutions in the U.K.
Results will inform protocol design of Phase 1/2 clinical trial of Company's lead HSV-2 therapeutic vaccine candidate
WOBURN, Mass. and OXFORD, England, Aug. 15, 2022 /PRNewswire/ -- Rational Vaccines, a company focused on revolutionizing the treatment and prevention of herpes to eradicate the disease, today announced the launch of a 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 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.
The study, "A Study of the Characteristics of Patients Diagnosed With Recurrent Symptomatic Genital Herpetic Disease," will be led by Dr. Rajul Patel, consultant physician for genitourinary and HIV medicine at Southampton University Hospital, Southampton, England. The trial will be conducted at Southampton University Hospital, and at Chelsea and Westminster Hospital, London, England.
"Most people living with herpes are unaware they have the infection leading to unrecognized transmission and spread of the virus. 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," said Kerstin Westritschnig, M.D., chief medical officer of Rational Vaccines. "There is no cure for herpes. There are no approved vaccines or immunotherapies or sufficiently reliable diagnostics currently available1. 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.
About Herpes Simplex Virus (HSV)
The 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. HSV-2 is the primary cause of genital herpes. According to a 2020 report by the World Health Organization (WHO), herpes infects billions globally2 – about a half a billion people worldwide are living with genital herpes, and several billion have an oral herpes infection. Both HSV-1 and HSV-2 infections are lifelong.
While most herpes infections are asymptomatic, a significant number of people experience a range of symptoms that vary in frequency and severity. The most common symptoms for both types of herpes are painful blisters or ulcers. In addition, many patients experience debilitating neuralgia, skin splits, fissures, minor abrasions, erythema, fever, chills, and myalgias. Both viruses are most contagious during a symptomatic outbreak, but they can still be transmitted in the absence of symptoms. Strong evidence has emerged that HSV-1 is a major risk factor for Alzheimer's disease3.
About Rational Vaccines
Rational Vaccines is revolutionizing the treatment, prevention, and diagnosis of herpes and herpes-related diseases with its rationally engineered, live-attenuated viral immunotherapeutic and prophylactic vaccine candidates. Led by a team of world-renowned scientists, the Company is headquartered in Woburn, MA with locations in Miami, FL and Oxford, UK. For more information, please visit www.rationalvaccines.com.
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SOURCE Rational Vaccines