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Rational Vaccines Announces a Clinical Study of the Frequency of Symptomatic Herpes Simplex Type 1 and 2 (HSV-1 and HSV-2) Virus in HIV Patients

WOBURN, Mass. and OXFORD, England, Dec. 14, 2021. 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 investigate the disease burden of herpes simplex virus types 1 and 2 (HSV-1 and HSV-2) in patients with HIV infection. The study, "A 48 Week Observational Study of the Frequency of Symptomatic Herpes Virus I and II in HIV Infected Subjects," will be led by Jorge E. Rodriguez, MD and conducted at the Global Research Institute in Los Angeles, CA.

People with compromised immune systems, such as those with advanced HIV infection, are impacted by herpes. Infections with HSV-1 and HSV-2 are a common occurrence in patients infected with HIV. Patients may develop herpetic lesions at one or multiple sites including the lips and oropharynx, genitalia, anus, fingers, and skin. The purpose of this study is to determine the frequency of such outbreaks in an HIV-positive population with recurrent HSV infection.

Kerstin Westritschnig, MD, chief medical officer of Rational Vaccines stated, "HIV patients co-infected with HSV are acutely suffering. HSV symptoms can be more severe and recur more frequently in HIV positive individuals than in people who are HIV negative. In addition, HSV-2 fuels the HIV epidemic by increasing the risk of acquiring and transmitting HIV infection three-fold 1. We look forward to the outcome of this observational study that aims to investigate the disease burden of HSV in HIV patients. These findings will be informative as we advance novel therapeutic and preventive HSV vaccine candidates, which could contribute as additional tools in fighting against the spread of HIV."

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 globally – 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. Beyond physical symptoms, herpes patients often suffer from social stigma and isolation because the infection is often transmitted sexually. Strong evidence has emerged that HSV-1 is a major risk factor for Alzheimer's disease 2.

There is no cure for herpes. There are no approved vaccines or immunotherapies or sufficiently reliable diagnostics currently available 3. Antiviral medications developed in the 1970s can help to reduce the severity and frequency of symptoms but cannot cure the infection.

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.

1. WHO first global and regional estimates of HIV infections attributable to HSV-2 infection
Herpes - STI Treatment Guidelines (cdc.gov)

2. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6075814/

3. https:/www.who.int/news-room/fact-sheets/detail/herpes-simplex-virus

SOURCE Rational Vaccines

Posted: December 2021

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