Phase I clinical trial (NCT01546818) in HIV-infected individuals Funded by Sumagen Canada, the government of Canada and the Bill and Melinda Gates Foundation, it started in March 2012 to assess its safety, tolerability, and immune responses. This was a randomized, double-blind, placebo-controlled trial, administering vaccine intramuscularly to 33 chronic HIV-1 infected individuals being treated with HAART. The trial was completed in August 2013. It reported no serious adverse effects. The vaccine induced antibodies in participants. Antibodies against gp120 surface antigen and P24 capsid antigen increased up to 6-fold and 64-fold, respectively, and the increased level of antibody was continued throughout the 52-week study period. Broadly neutralizing antibodies were found in some blood samples of the participants. Phase II clinical trial The Phase II clinical trial was expected to begin in 2018 in the United States to measure immune responses. The researchers planned to recruit about 600 HIV-negative volunteers who are in the high risk category for HIV infections such as commercial sex workers, men who have sex with men (MSM), injecting drug users, and people who have unsafe sex with multiple partners. Therapeutic HIV vaccine status Dr. Kang has also developed a therapeutic HIV vaccine employing recombinant vesicular stomatitis viruses carrying of HIV-1gag, pol and/or env genes. Researchers reported that the therapeutic vaccine induced robust cellular immune responses in animal tests recently conducted.
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