- Please see here for additional information regarding VIBLOK.
The CLJI Worldwide SAFE Trial is designed to evaluate the performance of the investigational device, VIBLOK, for adults infected with herpes simplex virus-2 (HSV-2). Over 80% of total study participants are already enrolled in the prospective, comparative multi-center SAFE Trial. Anticipated to last 12 months, the VIBLOK SAFE Trial will likely enroll the required participants ahead of schedule.
Dr. Annet Muetstege, Director of Clinical Affairs at Applied Clinical Services and clinical project manager of the VIBLOK SAFE Trial, emphasized that interest in the SAFE Trial has been remarkable. "In all of my years running clinical trials," says Dr. Muetstege, "I have never seen such fast enrollment and continuous in-flow of interested and eligible subjects."
VIBLOK is a virtually colorless, odorless, and tasteless cream designed to create a protective skin barrier that prevents the passage of viruses (e.g., HSV-2). The SAFE Trial will provide an indication as to whether VIBLOK can safely and effectively block virus passage across the skin in HSV-2 infected people and in doing so, target the currently high prevalence of this sexually transmitted infection (STI) in industrialized and developing countries. If approved, VIBLOK may be used by HSV-2 infected people to prevent spreading the virus, or by non-infected individuals to avoid acquiring the STI.
"The extraordinary interest in the SAFE Trial is indicative of a true unmet need in the prevention of HSV-2 transmission, which VIBLOK has been developed to address," says Ty Cross, President and Chief Executive Officer of CLJI Worldwide.
Across the globe, the prevalence of STIs has continued to increase over time, despite efforts to increase awareness, education, and prevention. Genital herpes, caused by HSV-2, is a common, chronic, recurrent, viral STI affecting over 400 million people worldwide. With women more susceptible than men, approximately 19 million people total are newly infected with HSV-2 annually and carry the disease for life (no treatment exists to eradicate the herpes simplex virus from the body). In comparison to other common STIs (e.g., Chlamydia, Gonorrhoeae and Syphilis), the global prevalence of HSV-2 is higher .
In the absence of a cure, treatment of HSV-2 focuses on symptom relief once a genital lesion develops, reducing recurrent episodes of lesion development, and preventing viral transmission between sexual partners. Not only are genital lesions due to HSV-2 often very painful, they also increase the risk of acquiring and transmitting HIV. An HSV-2 seropositive individual is 2-3 times more likely to acquire HIV, while an HIV-infected individual is 3 times more likely to transmit HIV if they are also HSV-2 seropositive [2-8].
In addition to physical symptoms, STIs may cause psychological and psychosexual morbidity. Among some individuals with recurrent genital herpes, a range of emotional responses may be seen, including depression, anguish, distress, anger, diminution of self-esteem and hostility towards the person believed to be the source of infection .
"A number of individuals in the trial have shared the emotional distress they experience as a result of having HSV-2," explains Aletha Veenendaal, Principle Investigator at the EB Flevo clinical trial site in The Netherlands. "One trial participant burst into tears as she described her confusion and heartbreak when her ex-boyfriend, who denied giving her HSV-2, left her with recurrent outbreaks." Veenendaal continues, "Now, many years later, she hopes that something positive will come out of her experience."
Despite the use of medical treatments and condoms, genital herpes transmission may still occur through unprotected areas of the skin via micro-sized lesions, which are often exacerbated by grooming practices of the genital area, such as shaving and waxing . Furthermore, while most people with HSV-2 are asymptomatic, viral shedding occurs even when symptoms are not present and can lead to HSV-2 transmission . There is an immediate and growing need for STI prevention as more and more individuals are infected. In the United States, the CDC estimates that almost 20 million new STIs occur each year (50% among people aged 15-24 years old), accounting for nearly $16 billion in health care costs .
VIBLOK is an investigational device being evaluated in Europe and the outcomes of this clinical trial will be used to support the product application for CE Mark. It does not have an approved Investigational Device Exemption in the United States.
The SAFE Trial reflects just one of the pioneering studies, sponsored by CLJI Worldwide, that aims at investigating overlooked aspects of healthcare and subsequently solving real problems with scientifically and clinically proven products.
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