“We really need to accelerate the development of vaccines against herpes simplex virus.” Sami Gottlieb, WHO medical officer.
Figures released by the World Health Organisation (WHO) last week stated that 417 million people in the age group 15-49 age group are living with HSV-2. The recent estimates highlight not only the significance of this virus, but also the need to find a cure.
There are two strains of herpes simplex virus, the first strain of HSV-1 is commonly referred to as cold sores or mouth sores; the second strain of herpes HSV-2 causes painful genital sores and the only available treatment is daily doses of antiviral drugs that can reduce but not eliminate outbreaks.
The WHO estimates of infection rates have been shocking for many as it is far larger than first thought and makes the need to deliver a therapeutic vaccine that can not only prevent HSV-2, but also treat people who may already be infected all the more important.
How Admedus is working to create a cure for HSV-2
Admedus is working with Australian of the Year, Professor Ian Frazer, to harness his next-generation DNA vaccine technology in an effort to create a therapeutic vaccine for HSV-2. If the name Ian Frazer sounds familiar, it’s probably because his originating work lead to the marketed vaccine Gardasil, which is used to prevent HPV infections and the associated cervical cancers in 120 countries protecting millions of young people.
Admedus’ HSV-2 therapeutic vaccine is designed to enable, boost and support the body to fight against the disease. Therapeutic vaccines are aiming to treat disease rather a preventative vaccine, meaning it can be used in people who already have the disease, not just as a preventative measure, which is traditionally how vaccines are used.
The Admedus HSV-2 program has already completed a successful Phase I study, with results showing no safety issues and with 19 of 20 of the study participants showing a T-cell response where no previous immunity existed which is an early indicator of an effective immune response.
The HSV-2 therapeutic vaccine is now in a Phase II study and the primary endpoint of the study is the safety of the vaccine in people with the virus, and Admedus will be looking at additional endpoints such as reduction of symptoms and viral flares, which are related to HSV-2 lesion outbreaks, after vaccination.
Admedus has had hundreds of people register to participate in the Phase II study, and we are nearing full enrolment. More than 80% of the required study participants have either received their initial dosing regimen and the program is on track to have interim data by the end of 2015, with additional data from the study being available in 2016.
The clinical study design has an initial screening, after which study participants have a 45 day baseline observation period on trial entry before receiving the first of their three therapeutic vaccine injections. The trial is exploring two injection regimens, which will be administered by intradermal injection three times, with a four week break between each injection regime. The trial will also include a six month booster.
If you would like more information on our HSV-2 therapeutic vaccine trial, or if you or someone you know would like to register, please visit http://www.herpestrial.com.au/.
Chief Scientific Officer