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"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"
 
 
  Recruiting Safety and Immune Response Assessment Study of Killed-whole HIV-1 Vaccine (SAV001-H) in Chronic HIV-1 Infected Patients
 
"The antibody against p24 capsid antigen increased as much as 64-fold in some vaccinees while the antibody against gp120 surface antigen increased up to eight-fold. P24 is a structural protein that makes up most of the HIV viral core also known as the 'capsid.' High levels of p24 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. A glycoprotein, gp120, is necessary for attachment to cell surface receptors and also allows for the HIV virus to enter cells."
 
"Preliminary findings for SAV001-H have not only shown promise, but have exceeded expectations. Phase I of the clinical trials was approved and commenced with a small sample of HIV positive volunteers located at two clinics within Los Angeles. A sample size of 40 men and women were assigned to groups, with eighteen receiving the vaccine and six receiving the placebo. None of the participants given the vaccine suffered any adverse effects."
 
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SAV001-H: HIV Vaccine Has No Adverse Side Effects In Early Trial
 
http://www.huffingtonpost.com
 
Pharmaceutical company Sumagen Canada announced yesterday the successful completion of a Phase 1 Clinical Trial of SAV001-H, a vaccine against HIV and AIDS. The trial ran for over a year, from March 2012 through last month, and was designed to test the "safety, tolerability and immune responses" of the drug in real live human subjects. Phase 1 trials are the point at which researchers go from seeing whether their drugs work in animals to making sure that they don't do weird and bad stuff to people, so the stakes are obviously very high.
 
SAV001-H passed flawlessly: in the randomized, observer-blinded, placebo-controlled study of HIV-infected, asymptomatic men and women, there were "no serious adverse event[s]," meaning that Phase 2 trials (seeing how well the vaccine actually works) can come next.
 
SAV001-H is what's called a "killed whole virus vaccine," meaning that it includes actual HIV viruses. This sounds like something that you don't want to get injected with, but as part of the vaccine-making process, the live HIV viruses are genetically re-engineered to eliminate pathogenicity, chemically treated, and then irradiated with gamma rays to make sure that they're dead dead dead. While other HIV/AIDS vaccines that haven't used killed whole viruses (relying instead on targeting specific components of HIV) have failed in Phase 3 trials, Sumagen is optimistic about their drug because other successful vaccines (including polio, influenza, rabies, and hepatitis A) work on the same principle.
 
The vaccine prevents HIV infection by massively boosting the production of a variety of antibodies in the human immune system. We won't get detailed statistics on how effective SAV001-H is until the completion of the Phase 2 trials, but even during Phase 1, the researchers were able measure boosts in the production of a variety HIV-specific antibodies ranging anywhere from eight to 64 times higher than with a placebo. Plus, these increases in antibodies were maintained over the entire duration of the study. Based on these data, Sumagen is "[forecasting] a success of the Phase 2 human clinical trial."
 
It would be premature to get too excited about this, since many vaccines encounter issues in Phase 2 and Phase 3 clinical trials. But, we're excited anyway. 35 million people have died of HIV/AIDS, and nearly as many are currently infected. 40% of new infections occur in people between the ages of 15 and 24. According to Sumagen, when this vaccine comes to market (and it's getting closer), it could mean "the eradication of HIV/AIDS for human beings." Eradication. Forever.
 
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http://www.pharmaceutical-technology.com/features/featuretrialing-first-ever-hiv-vaccine-human-clinical
 
Trialling the first ever HIV vaccine
 
24 January 2013
 
In October 2012, Canadian scientists announced that they may have discovered the first and only preventative HIV vaccine that has shown no adverse effects in Phase I human clinical trials. Despite the failure of all previous attempts, the promise of a vaccine with no adverse side effects has ignited a new surge of hope in the fight against HIV, but how does this vaccine differ? Dr Nicola Davies reports.
 

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The HIV virus has posed great challenges for scientists, primarily because of the way the virus compromises the body's immune system. The HIV virus is what is termed as a "retrovirus" because it can integrate its genetic material into key chromosomes within the body and replicate. Once it has made its mark within the chromosomes, it remains latent and becomes resilient to any form of treatment or attack.
 
In this way, the HIV virus is different from other retroviruses in that it has the ability to evade the body's natural defense systems. It also directly targets the cells that are responsible for the response to any viral pathogen, and has an uncanny ability to mutate frequently and quickly in response to any attempts made by the body's defense system.
 
Previous attempts at developing an HIV vaccine, despite passing Phase I of clinical trials, have failed to show any promise in the fight to find a cure for this resilient disease. A vaccine was tested by the National Institute of Allergy and Infectious Diseases (NIAID) and the New Jersey pharmaceutical company Merck & Co. - V520 - which was designed to stimulate HIV-specific cellular immunity.
 
In their STEP trial, which comprised of 3,000 participants from across the world, it was found that the vaccine might actually increase risk of HIV infection. Consequently, trials were discontinued on the advice of the Independent Data and Safety Monitoring Board (DSMB).
 
SAV001-H: activating the natural immune response
 
"Previous attempts at developing an HIV vaccine have failed to show promise in the fight to find a cure for this resilient disease."
 
The vaccine being tested by Canadian scientists is known as SAV001-H, which contains whole, killed HIV-1 and works in the same manner as similar vaccines used for influenza, rabies, polio and hepatitis A. Unlike the more traditional attempts to prevent the HIV virus, the SAV001-H vaccine works by activating the body's natural immune response to fight the virus.
 
The body's response to the HIV vaccine, like its response to other vaccines, is the activation of the immune system to produce antibodies specific to fighting the offending virus.
 
To date, it is the first time ever that scientists have used the whole virus to create a vaccination. Indeed, until now vaccines have been focused on using certain proteins or genes from the virus, but not the virus in its entirety. The whole virus used in SAV001-H is a derivative of the HIV-1 virus and has been genetically altered in such a way that it cannot cause HIV in someone who is injected with it. As a further precaution, to prevent possible infection, the virus is radiated and treated with chemicals.
 
Exceeding expectations: a HIV vaccine with no side effects
 
Preliminary findings for SAV001-H have not only shown promise, but have exceeded expectations. Phase I of the clinical trials was approved and commenced with a small sample of HIV positive volunteers located at two clinics within Los Angeles. A sample size of 40 men and women were assigned to groups, with eighteen receiving the vaccine and six receiving the placebo. None of the participants given the vaccine suffered any adverse effects.
 
"Preliminary findings for SAV001-H have exceeded expectations."
 
Furthermore, an increase in the body's defence cells was almost tenfold more than what researchers had anticipated.
 
To ensure there are no long-term reactions to participation in the trial, volunteers have been followed in six-month intervals, to check for any adverse symptoms.
 
No adverse side-effects have arisen, providing more credence to furthering clinical trials in efforts to pave the way for finding an effective treatment or, indeed, a cure for the HIV virus.
 
Lead scientist Dr Chil-Yong Kang, at the University of Western Ontario, Canada, says: "We are so excited about this interim report and are now proceeding with preparations for Phase II."
 
Advancing clinical trials: Phases II and III
 
"Phases II and III of SAV001-H trials are on the horizon; participants will be HIV negative volunteers who are at high risk."
 
Phases II and III of SAV001-H trials are on the horizon for 2013, when participants will be HIV negative volunteers who are at high risk for contracting the disease.
 
Phase II will comprise of a sample group of 600 and Phase III a much larger group of 6,000. The trials are set to be held in Canada, the United States and Europe, the rationale being that taking a cross-sectional group of individuals from different countries will enhance the rigour of any findings.
 
Whether Phases II and III continue to produce such positive findings remains to be seen. At best, the hope is that the trials will continue to demonstrate no adverse effects to participants.
 
Despite the limitations of clinical trials and some skepticism over the findings, Dr Kang remains confident, stating that: "We expect to get great news from volunteers in Phase II."
 
Tremendous promise
 
Not only did the SAV001-H vaccine have no adverse effects on trial participants, but it was also shown to significantly boost immunity in those it was administered to. This is the first ever trial to show promise in the fight against a disease that has persistently challenged the medical community.
 
Indeed, although ongoing research has made HIV less of a fatal disease and more of a chronic illness, the adverse consequences on those who have the disease remain devastating. It is, therefore, not surprising that the "tremendous promise" of developing a vaccine with no adverse effects, as offered by Dr Kang and his team, has sparked excited anticipation among the medical community. In the words of Dr Kang: "If we can eradicate HIV, or if we can prevent HIV infection, certainly that will be the happiest achievement I can accomplish."
 
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HIV vaccine produces no adverse effects in trials
 
By Communications Staff September 03, 2013
http://communications.uwo.ca
 
Editor's note: Dr. Chil-Yong Kang of Western's Schulich School of Medicine & Dentistry will be online at 10 a.m. Friday, Sept. 6, answering questions about the Phase I clinical trial of the Sumagen AIDS vaccine as part of an Ask Me Anything (AMA) on Reddit.
http://www.sumagen.co.kr/english/business/aids_vaccine.htm
 

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Photo 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.
 
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 virus 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 adverse effects 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 clinical trials 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 vaccine has been manufactured at a bio-safety level 3 (BSL3) good manufacturing practice (GMP) facility in the United States.
 
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HIV/AIDS vaccine passes Phase 1 clinical trial in humans
 
Evan Ackerman
Wednesday, September 4, 2013
http://www.dvice.com
 
Human Testing
 
The clinical trial, which evaluated safety, tolerability, and immune responses, was initiated in March 2012 and completed in August 2013. The study of the vaccine, known as SAV001-H, followed intramuscular administration in HIV-infected, asymptomatic men and women, 18 to 50 years of age. The trial studied the vaccine's effects on volunteers as compared to a placebo group. After receiving the vaccination, volunteers visited test sites on weeks four, six, 12, 18, 26, and 52 for a general physical examination as well as analysis of clinical chemistry, hematology, and urinalysis. Researchers observed no serious adverse events and also found a surprising boost in antibody production, which may forecast success in Phase 2 trials measuring immune response. The antibody against p24 capsid antigen increased as much as 64-fold in some vaccinees while the antibody against gp120 surface antigen increased up to eight-fold. P24 is a structural protein that makes up most of the HIV viral core also known as the 'capsid.' High levels of p24 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. A glycoprotein, gp120, is necessary for attachment to cell surface receptors and also allows for the HIV virus to enter cells.
 
The increased antibody titers were maintained during the 52-week study period. Production
 
SAV001-H, which was produced at a manufacturing facility in the U.S., is the only HIV vaccine developed in Canada and one of only a few in the world. Sumagen anticipates having the first HIV vaccine approved for market. HIV currently affects more than 34 million people who live with the virus worldwide, according to the World Health Organization. Over the past three decades, HIV has claimed more than 25 million lives.
 
Since the virus was characterized in 1983, pharmaceutical companies and academic institutions around the world have attempted, yet consistently failed, to develop a vaccine. What is unique about Kang's vaccine is its use of a killed-whole HIV-1, which is similar to the vaccines developed for polio, influenza, and rabies. HIV-1 is also genetically engineered; this raises its safety profile and the possibility of it being produced in large quantities. Sumagen is a member of Curo Group, a Seoul-based company with subsidiaries or affiliates in financial services, information technology, and other business areas. Sumagen has secured patents for the SAV001 vaccine in more than 70 countries, including the U.S., the European Union, China, India, and South Korea.
 
Development of Sumagen's HIV vaccine has been supported by the government of Canada as well as the Bill and Melinda Gates Foundation.
 
Sumagen, the South Korean biotech firm sponsoring the vaccine, cited manufacturing, as well as USFDA requirements as hurdles in bringing the vaccine to market, but, if all goes well in trials, it could be commercially available in five years.
 
"We are now prepared to take the next steps towards Phase II and Phase III clinical trials," CEO Jung-Gee Cho said in a press release.
 
"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."
 
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 non-pathogenic 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 U.S., the European Union, China, India and South Korea. The vaccine has been manufactured at a bio-safety level 3 (BSL3) good manufacturing practice (GMP) facility in the United States.
 
Located in The Stiller Centre for Technology Commercialization in Western's Research Park in London, Ontario, Sumagen Canada was established in 2008 specifically to manage and support clinical development of Kang's vaccine. Sumagen Canada is a subsidiary of Sumagen Co. Ltd., a Korean-based pharmaceutical venture company.

 
 
 
 
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