HIV vaccine produces no adverse effects in trials

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

Phase I Clinical Trial (SAV CT 01) of the first and only preventative HIV vaccine based on a genetically modified killed whole virus (SAV001-H) has been successfully completed with no adverse effects in all patients, Western and Sumagen Canada Inc. announced today.

Developed by Dr. Chil-Yong Kang and his team at the Schulich School of Medicine & Dentistry, with the support of Sumagen Canada, the vaccine (SAV001-H) holds tremendous promise for success in the final phases of clinical testing now that the first hurdle has been accomplished. It is the only HIV vaccine developed in Canada currently in clinical trial, and one of only a few in the world.

This vaccine is the first genetically modified killed whole vaccine (SAV001-H) 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. This trial was a 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, have been enrolled in this study and randomized into two treatment groups to administer killed whole HIV-1 vaccine (SAV001-H) or placebo.

The after vaccination were recorded on a volunteer diary card by the volunteers seven days after vaccination. Thereafter, the volunteers visited 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.

In addition to safety evaluation, HIV-1 specific antibody detections have been performed 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. The increased antibody titers were maintained during the 52 week study period. The boost antibody production in HIV-positive volunteer vaccines is highly encouraging, since it forecasts a success of the Phase 2 human clinical trial, which will measure 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.

SAV001-H is the first genetically modified killed whole virus vaccine (SAV001-H) in human clinical trial and proving its safety was the major concern for going forward for next steps. 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.

"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. "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."

HIV/AIDS has killed 35 million people worldwide, and more than 34 million people currently live with the virus infection. Since the virus was characterized in 1983, there have been numerous trials through pharmaceutical companies and academic institutions around the world to develop vaccines; however, no vaccine has been successful to date. Other HIV vaccines evaluated through human have focused on either one specific component of HIV as an antigen, genetic vaccine using recombinant DNA, or recombinant viruses carrying the HIV genes. Kang's vaccine is unique in that it uses a killed whole HIV-1, much like the killed whole virus vaccines for polio, influenza, rabies and hepatitis A. The HIV-1 is genetically engineered so it is safer and can be produced in large quantities.

Through WORLDiscoveries, Western's technology transfer office, Sumagen Canada has secured patents for the SAV001 vaccine in more than 70 countries, including the United States, European Union, China, India and South Korea. The has been manufactured at a bio-safety level 3 (BSL3) good manufacturing practice (GMP) facility in the United States.

Related Stories

Experimental aids vaccine now in production

date Nov 12, 2008

(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 ...

Experts urge renewed push on US-Thai HIV vaccine

date Aug 29, 2013

Health experts on Thursday called for trials of an HIV vaccine under development in Thailand to be speeded up following recent setbacks in other efforts to end the AIDS epidemic.

HIV/AIDS vaccines: Defining what works

date Jul 18, 2013

Designing an effective HIV/AIDS vaccine is something of a paradox: a good vaccine would be safe and look enough like HIV to kick-start the immune system into neutralizing the virus – but the problem is that this is exactly ...

Recommended for you

Mathematical model seeks functional cure for HIV

date 50 minutes ago

(Medical Xpress)—Individuals with the natural ability to control HIV infection in the absence of treatment are referred to as elite controllers (ECs). Such individuals maintain undetectable viral loads ...

Indiana HIV outbreak, hepatitis C epidemic sparks US alert

date Apr 24, 2015

Federal health officials helping to contain an HIV outbreak in Indiana state issued an alert to health departments across the U.S. on Friday, urging them to take steps to identify and track HIV and hepatitis C cases in an ...

Why are HIV survival rates lower in the Deep South than the rest of the US?

date Apr 22, 2015

The Deep South region has become the epicenter of the US HIV epidemic. Despite having only 28% of the total US population, nine states in the Deep South account for nearly 40% of national HIV diagnoses. This region has the highest HIV diagnosis rates and the highest number of people living with HIV of any ...

A bad buzz: Men with HIV need fewer drinks to feel effects

date Apr 20, 2015

Researchers at Yale and the VA Pittsburgh Healthcare System compared the number of drinks that men with HIV infection, versus those without it, needed to get a buzz. They found that HIV-infected men were more sensitive to ...

User comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.