First-Ever Preventative HIV Vaccine Trials Show No Adverse Effects

Doctors in Canada have discovered no adverse effects in patients who participated in the Phase I Clinical Trial for the first ever preventative HIV vaccine. On Sept. 3, Western and Sumagen Canada Inc. announced the encouraging results of what is one of only very few HIV vaccine trials in the world.

"Even though Sumagen has struggled and spent a much longer time to overcome manufacturing difficulties and to meet the USFDA's requirements, we have accomplished successfully Phase I Clinical Trial of SA001-H and proven that there is no safety concern of SAV001-H in human administration," said Jung-Gee Cho, Sumagen CEO.

The vaccine is based on a genetically modified killed whole virus (SAV001-H), developed by Dr. Chil-Yong Kang and his team at the Schulich School of Medicine & Dentistry, with the support of Sumagen Canada. The vaccine holds tremendous promise for success in the final phases of clinical testing now that the first hurdle has been accomplished.

The randomized, observer-blinded, placebo-controlled study of killed whole HIV-1 vaccine (SAV001-H) following intramuscular (IM) administration. HIV-infected, asymptomatic men and women, 18-50 years of age, were enrolled in this study and randomized into two treatment groups to administer killed whole HIV-1 vaccine (SAV001-H) or placebo.

It is the first genetically modified killed whole virus vaccine in human clinical trial to evaluate its safety, tolerability and immune responses. The human clinical trial was initiated in March 2012 and completed in August 2013.

Volunteers recorded any adverse affects in a diary, seven days after the vaccination. They followed up on the test sites on Weeks 4, 6, 12, 18, 26 and 52 after vaccination and were analyzed for hematology, clinical chemistry, urinalysis and physical examination by principal investigators. No serious adverse event was observed in any volunteer vaccines throughout the observation periods.

According to an article in Medical Daily, doctors also performed HIV-1 specific antibody detections throughout the follow up period. The antibody against p24 capsid antigen increased as much as 64-fold in some vaccines and antibody against gp120 surface antigen increased up to eight-fold after vaccination. A glycoprotein, gp120 is necessary for attachment to cell surface receptors and also allows for the HIV virus to enter cells.

And p24 is a structural protein that makes up most of the HIV viral core also known as the 'capsid.' High levels of it are present in the blood serum of newly infected individuals during the short period between infection and seroconversion, making p24 antigen assays useful in diagnosing primary HIV infection.

The increased antibody tiers were maintained during the 52-week study period. The boost in antibody production in HIV-positive volunteer vaccines is encouraging, as it forecasts a success of the Phase 2 human clinical trial measuring the immune responses.

In particular, the antibody against gp120 surface antigen is considered to be very important, since some of these antibodies may represent the broadly neutralizing antibodies, which seem to be the most important parameter of an effective HIV vaccine for prevention of HIV-infection.

With these encouraging results from the Phase I Clinical Trial, Sumagen is confident in developing SAV001-H as the first preventative HIV vaccine for saving millions of lives and is now preparing for the next phases of trials to show the immunogenicity and efficacy.

"We are now prepared to take the next steps towards Phase II and Phase III clinical trials. We are opening the gate to pharmaceutical companies, government, and charity organization for collaboration to be one step closer to the first commercialized HIV vaccine," said Cho.

Sumagen's unique technology and technique in HIV vaccine development is protected by global patents and has the full support of Curo Group, the parent company group of Sumagen. The company recently acquired USFDA approval on the Phase I clinical trials using Sumagen's SAV 001, the HIV/AIDS vaccine candidate. Development of Sumagen's HIV vaccine has been supported by the government of Canada as well as the Bill and Melinda Gates Foundation.

"Although many steps and stages remain before commercializing SAV 001, Sumagen is committed to reaching commercialization of this HIV vaccine and ultimately to 'saving humanity from the pain and fear of AIDS,'" wrote Cho on the company's website.