HIV Vaccine phase II clinical trials have begun

SAV001, an HIV vaccine developed by Chil-Yong Kang and a research team at Western’s Schulich School of Medicine has successfully completed phase 1 trials. The results of the Phase I trial were published in the journal, Retrovirology, and showed that the vaccine is both safe for use and effective in triggering an anti-HIV immune response in HIV-positive patients. The results demonstrated that the vaccine was well tolerated with no serious adverse events and can now proceed to Phase II.

The SAV001, contains a genetically modified and killed version of an HIV virus and it is safe and well tolerated after a single intramuscular injection. The combination of chemical and physical inactivation procedures is adequate to completely kill the genetically modified HIV-1 NL4-3 virus while retaining the function and immunogenicity of viral proteins. Vaccination with SAV001 could enhance humoral immune responses including broadly neutralising antibody production in HIV-1 negative individuals. Therefore, SAV001 represents a promising starting point for development of a safe and effective HIV-1 vaccine using the killed whole virus approach.


HIV/AIDS has killed more than 41 million people worldwide, and more than 35 million people currently live with the infection.

The vaccine is being tested in partnership with Sumagen Canada, the Canadian branch of Korean pharmaceutical venture company, Sumagen Co. Ltd. which has been producing the vaccine for clinical trials and holds the patent on the vaccine for mass production and distribution.

Plans are underway to test it in 600 HIV-negative subjects across North America as early as next fall. The Phase II trial, once approved by government regulatory agencies, will determine the vaccine’s ability to produce anti-HIV antibodies in patients who are not infected with the virus.

The proposed next phase will involve 300 volunteers from the general population, and 300 from groups considered high-risk including men who have sex with men, intravenous drug users, sex workers, and those living with an HIV-positive partner.

The SAV001 vaccine is unique in that it uses a killed whole HIV-1, much like the killed whole virus used in vaccines for polio, hepatitis A, rabies, and the flu. The killed HIV-1 is genetically engineered so it is less dangerous and can be produced in large quantities. The vaccine is the world’s first preventative HIV vaccine using genetically modified killed whole-virus to receive approval by the United States Food and Drug Administration (FDA) to proceed to this phase of human clinical trials.

Once Phase II has been successfully completed, Phase III will be conducted world-wide with 6,000 subjects and will be the true test to show if the vaccine is effective in protecting people against HIV infection.

Author: Kavish Khatib

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