(PhysOrg.com) -- The advance towards a vaccine for HIV/AIDS has taken another step closer to realization. A vaccine, developed by Dr. Chil-Yong Kang and his team at the Schulich School of Medicine & Dentistry at The University of Western Ontario, and licensed to Sumagen Canada Inc., has now been manufactured for use in trials - first, in toxicology trials using animal models and then in Phase 1 human clinical trials.
The vaccine has been manufactured at a bio-safety level 3 (BSL3) good manufacturing practice (GMP) facility in the United States.
“It has been very difficult to manufacture our genetically engineered HIV-1 experimental vaccine, because there are only a few BSL3 GMP contract manufacturing organizations (CMO) available in the world. For this reason, we welcome the Canadian Government’s plan to establish a BSL3 GMP facility in Canada for future manufacture of candidate HIV/AIDS vaccines. We have overcome a major hurdle in the development of our HIV/AIDS vaccine which is now ready for clinical trials,” said Dr. Dong Joon Kim, CEO of Sumagen.
The toxicology trials will get under way in a matter of days at a contract research organization (CRO) in the U.S., and results should be ready in approximately three months. The Phase 1 human clinical trials could begin in early spring at a number of trial sites in North America.
Kang's vaccine uses a killed whole HIV-1, much like Salk's killed whole poliovirus vaccine. The HIV-1 is genetically engineered in such a way that it is non-pathogenic and can be produced in large quantities. It is then purified, inactivated, and injected as a safe whole killed-virus vaccine.
While Phase 1 human clinical trials are most often conducted on healthy volunteers, in the case of this HIV/AIDS vaccine, it will be tested on individuals who are HIV-positive, but not yet symptomatic with AIDS.
More than 25 million people have died of AIDS since 1981 and approximately 35 million people live with HIV infection world-wide today.
Sumagen Canada Inc. is a subsidiary of Curocom of Korea. The company is fully funding Dr. Kang’s continuing work on the HIV/AIDS vaccine development.
Provided by University of Western Ontario