Herpes simplex vaccine candidate clinical trial launched
The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced the launch of phase 1 clinical trials into an investigational genital herpes vaccine, according to an agency press release Friday.
Herpes virus/CDC
Currently, there is no preventive vaccine for genital herpes, Approximately three-quarters of a million people are infected with herpes simplex virus type 2 (HSV-2) and herpes simplex virus type 1 (HSV-1) annually.
“Although genital herpes is treatable, it is a lifelong infection that can exact a substantial psychological and physical toll on infected individuals and places them at higher risk of acquiring HIV,” said NIAID Director Anthony S. Fauci, M.D.
“Furthermore, mothers with active genital herpes infection at time of delivery can transmit the virus to their newborns, which can lead to severe illness and death.”
“A protective vaccine would help to reduce significantly the spread of this all-too- common sexually transmitted infection,” Fauci added.
The investigational vaccine candidate, called HSV529, will be tested in the trials for safety and the its ability to illicit an immune response.
According to the NIH release:
The clinical trial is expected to enroll 60 adults ages 18 to 40, who will be divided into three groups of 20 participants each. The first group will be of people who have been previously infected with HSV-2 and HSV-1 or solely with HSV-2; the second will have individuals who had been infected with HSV-1 only; and the third will consist of those who have not been infected with HSV-1 or HSV-2. The investigational vaccine is being tested among study participants who have previously been infected with HSV to determine if it may pose any safety issues.
Within each of the three groups, researchers will randomly assign participants to receive three doses (0.5 milliliters each) of the investigational HSV529 vaccine (15 participants) or a saline-based placebo vaccine (five participants). The three vaccinations will occur at study enrollment and again one month and six months later. Participant safety will be monitored throughout the course of the trial, and researchers will follow participants for six months after they have received their last dose of vaccine. Blood samples will be used to evaluate the candidate vaccine’s ability to stimulate immune system responses to HSV-2, including production of virus-specific antibodies and T-cell responses. The study is expected to be completed by October 2016.
Early in 2012, Glaxo SmithKline pulled the plug on the trials on their vaccine, Simplirix, after it failed clinical trials.
HSV-2 is generally transmitted through sexual contact and can spread even when the infected individual shows no symptoms. Although HSV-1 commonly infects the mouth and lips, it can also cause genital herpes. Once in the body, HSV migrates to nerve cells and remains there permanently, where it can reactivate to cause painful sores and blisters.
For more info on the clinical trial, click here
[…] Nov. 2103, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced the launch of phase 1 clinical trials […]
[…] Nov. 2103, the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced the launch of phase 1 clinical […]
[…] Herpes simplex vaccine candidate clinical trial l…The Global DispatchThe National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH), announced the launch of phase 1 clinical trials into an investigational genital herpes vaccine, according to an agency press release …Agenus announces positive phase II study results of HerpV therapeutic vaccine …pharmabiz.com […]