600 HIV-Negative Participants to Test Vaccine Next Fall

Developed at Canada’s Western University, the HIV vaccine SAV001 will be moving from Phase I to Phase II clinical trial beginning the fall of 2017 at the earliest.  During the Phase I clinical trial 33 HIV-positive participants were administered the vaccine and it showed no serious adverse effects and that the vaccine triggered an anti-HIV immune response.

The Phase II clinical trial will determine how effective the vaccine can trigger an anti-HIV antibody response in those without the virus (Western University, 2016).  Of the 600 HIV-negative participants, 300 will be volunteers from the general North American population, and the other 300 will come from a high-risk HIV group (Western University, 2016).  This group includes those living with a partner that is HIV-positive, sex workers, men who have sex with men, and IV drug users (Western University, 2016).  If successfully completed, Phase III will be conducted on 6000 subjects on a world-wide scale and will be the vaccines true test (Western University, 2016).

More on the breakthrough can be read here.  If you have any questions, please feel free to contact Focal Point Research.  We are industry leading Drug and Cosmetic Regulatory Consultants that you can trust to help guide your company in the right direction.