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Signs herpes outbreak is coming

Most people “shed” virus asymptomatically, which actually accounts for the majority (~70%) of transmission events.5 HSV-2 shedding can be readily monitored by measuring the amount of viral DNA from genital swabs using a validated PCR assay, such as the widely-used assay developed at the University of Washington.
A high unmet medical need exists for treatments that reduce HSV-2 genital herpes recurrences and viral transmission, because no licensed therapeutic vaccine exists for this indication. Therapeutic vaccines represent a new treatment modality against herpes viruses, especially HSV-2.
The plasmid DNA vaccine technology developed at Vical is an attractive vaccine strategy against HSV-2 because induction of robust T-cell responses is a hallmark of this platform.9 Furthermore, plasmid DNA vaccines are noninfectious and can be repeatedly used for vaccine boosting without generating antivector responses (as frequently occur with adenovirus, poxvirus, and other vaccine vectors).
Several considerations were of importance in the design and testing of Vical's HSV-2 therapeutic vaccine candidate. The use of Vaxfectin® as an adjuvant to potentiate the performance of the HSV-2-encoding plasmids is a critical component of Vical’s vaccine. The trial consisted of a dose escalation component to assess the safety of ? dose, ? dose, and a full dose of vaccines in a small number of subjects prior to dosing additional subjects at the full dose. Subjects in the efficacy cohort performed daily swabbing to measure HSV shedding rates both before vaccination and again after vaccination. With approximately 60 subjects per each vaccine group, the study was powered to show at least a 30% decrease in the shedding rate.
4 Looker KJ, Garnett GP, Schmid GP.An estimate of the global prevalence and incidence of herpes simplex virus type 2 infection. HotCopper is the largest stock market forum in Australia with over 250,000 registered members and more than 8,000 posts per day. 2016 is looking to be an important year for Admedus as our immunotherapy programs continue to progress well.
Admedus is currently using DNA vaccine technology to develop therapeutic vaccines targeting human papilloma virus (HPV) and herpes simplex virus 2 (HSV-2), although the technology developed by Admedus in conjunction with Professor Ian Frazer can potentially be applied to a range of viruses, bacterial infections and cancers. According to the Centers for Disease Control and Prevention, HPV is the most common sexually transmitted infection (STI). HPV is associated with a number of cancers including cervical cancer and cancer of the vulva, vagina, penis, and rectal cancer. HPV can remain asymptomatic and sometimes there is no way to know which people who have HPV will develop cancer or other health problems.
Using the principles of DNA vaccine technology, we optimise the HPV gene that makes the antigen and transfer it into agency approved DNA plasmids in order to manufacture large amounts of clean, safe and high quality DNA vaccine.
Once the vaccine enters into the cells, the cells themselves begin to make a small amount of the foreign antigen which in turn alerts the body’s immune cells to its presence. It’s important to note that not everyone who becomes infected with HPV will have it progress to cancer. In the US about 79 million people are currently infected with HPV and each year another 14 million people are infected. To date we have completed a number of successful pre-clinical studies with very exciting responses. Admedus is on track to initiate the first clinical study with the HPV vaccine after the successfully completed pre-clinical studies. Therapeutic vaccines, like those being developed by Admedus, typically have shorter clinical studies with fewer participants.


If you are interested in learning more about our work in HPV, please contact us via the website. DISCLAIMER:Before making any financial decisions based on what you read, always consult an advisor or expert. DNA vaccines offer the potential benefits of live-attenuated virus vaccines in stimulating T-cell responses but do not inherently possess the attendant safety concerns of live virus vaccines.
From the program’s inception, key collaborations were established with the laboratories of leading HSV experts Dr. All enrolled subjects were required to be HSV-2 seropositive, as established using the University of Washington’s Western blot assay.
Regardless of dose, subjects were to receive the vaccine or a placebo on days 0, 28, and 56. Importantly, sampling periods of 60 days for swab collections were designed for this study to generate robust shedding data to compare the pre-vaccination to the post-vaccination periods. Seroprevalence of Herpes Simplex Virus Type 2 Among Persons Aged 14–49 Years — United States, 2005–2008.
Genital shedding of herpes simplex virus among symptomatic and asymptomatic persons with HSV-2 infection. Mucosal host immune response predicts the severity and duration of herpes simplex virus-2 genital tract shedding episodes.
A novel therapeutic cytomegalovirus DNA vaccine in allogeneic haemopoietic stem-cell transplantation: a randomised, double-blind, placebo-controlled, phase 2 trial. Vaxfectin-adjuvanted plasmid DNA vaccine improves protection in a murine model of genital herpes infection. Phase 1 clinical trials of the safety and immunogenicity of adjuvanted plasmid DNA vaccines encoding influenza A virus H5 hemagglutinin.
A Vaxfectin-adjuvanted HSV-2 plasmid DNA vaccine is effective for prophylactic and therapeutic use in the guinea pig model of genital herpes.
Vical assumes no responsibility for content not provided by Vical, or for practices or standards of any non-Vical websites. Working with Professor Ian Frazer and his team, we are developing therapeutic vaccines to target human papilloma virus (HPV) and herpes simplex virus 2 (HSV-2).
This is done by delivering engineered DNA into the body so that a person’s own cells directly express an antigen. HPV is so common that nearly all sexually active men and women get it at some point in their lives. It can also cause cancer in the back of the throat, including the base of the tongue and tonsils (called oropharyngeal cancer), which is also associated with some head and neck cancers. The types of HPV that can cause genital warts are not the same as the types of HPV that can cause cancers.
This purified DNA vaccine is injected as a solution just under the skin surface (an area which has a high population of migrating immune cells). The Admedus technology adds ubiquitin to the antigen and this helps to flag to the immune system that there is a foreign antigen present. Even though our technology and Gardasil are both created by Professor Ian Frazer, they are very different vaccines.


Whilst Gardasil is a very effective vaccine, the current uptake is quite low, around 40%, and therefore the level of protection from HPV in the community is suboptimal.
In a model that replicates the HPV related cancer disease state, treatment with the Admedus HPV vaccine achieved 100% survival after 50 days, and over 85% had no detectable tumours after 50 days. As part of this study we will look at safety of the vaccine as well as and efficacy data in the study participants.
This is due to the fact we are looking at a more immediate response in the study participants. Therefore, an unmet need remains for additional treatment options such as a therapeutic HSV-2 vaccine. T cells induced to recognize important herpes antigens following therapeutic vaccination are likely to be key participants as antiviral mediators. Vical has already established the precedent of a therapeutic DNA vaccine against a related herpes virus, cytomegalovirus (CMV). In addition, these subjects were required to have a history of symptomatic genital herpes with 2 to 9 lesion recurrences per year; higher herpes shedding rates are observed in symptomatic compared to asymptomatic subjects6 and also permit the opportunity to explore potential reductions in lesions after vaccination.
Essentially the amount of viral shedding was measured for each subject at baseline (pre-vaccination) and then again after the intervention (completion of 3 vaccination series, the post-vaccination period). These vaccines address significant diseases with a huge unmet medical need and if successful, will positively impact patient lives.
The immune system will then target this antigen, thus resulting in a protective immunological response and activated immunity. The activated immune system is now on the lookout for anything resembling the foreign antigen, targeting the antigen and anything attached to it and clears it from the body. However, for those people where the HPV infection progresses to the early stages of cancer, Admedus is looking to replicate the process by using its DNA vaccines to produce safe (non-cancer causing) versions of the cancer related proteins in greater numbers and this will train the body into thinking there is a higher level of infected cells, effectively amplifying the immune system and assisting them to mount a better defence. Gardasil creates a prophylactic (antibody) response to protect you from HPV infection in the future. We feel there is an opportunity to work on a therapeutic vaccine to treat people infected with HPV and with HPV related cancers. Prophylactic vaccines, on the other hand, can take longer as they need to look at differences in large populations of people over a longer period of time. Larry Corey at the University of Washington to leverage their experience in selecting key HSV-2 antigens and in conducting numerous murine studies under a multi-year NIH grant. With this in mind, we wanted to shed some light on how our therapeutic vaccine works to target HPV related tumours and explain the science behind DNA vaccines. Admedus, on the other hand, is working on a DNA vaccine designed to target and clear HPV-positive tumour cells in people already infected, although the preclinical data indicates it may also work in boosting the immune system in uninfected people. For more information on our work to date in targeting HSV-2, please read our previous blog ‘World Health Organisation: You probably have herpes’.



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