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No adverse effects in volunteers following Phase I clinical trial of Sumagen AIDS vaccine

Posted by on Sep. 4, 2013 at 9:42 PM
  • 35 Replies
2 moms liked this
No adverse effects in volunteers following Phase I clinical trial of Sumagen AIDS vaccine

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September 03, 2013

Sumagen Canada Inc and Western University announced today that the 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. Antibody production was also boosted after vaccination.

Developed by Dr. Chil-Yong Kang and his team at Western's 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 to 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 vaccinees 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 vaccinees 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 vaccinees 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.

Sumagen anticipates not only having the first HIV vaccine in market but also the eradication of HIV/AIDS for human beings.

Mr. Jung-Gee Cho, the CEO of Sumagen Co. Ltd. says, "Even though Sumagen has struggled and spent a much longer time to overcome manufacturing difficulties and to meet the U.S. FDA'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. 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 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 U.S.
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by on Sep. 4, 2013 at 9:42 PM
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Replies (1-10):
lga1965
by on Sep. 4, 2013 at 9:48 PM
2 moms liked this

 Wow, isn't that interesting! I hope it is THE cure.

I wonder what the "anti-vax" groupies will say about this,though. Or the Fundies? Know what I mean?

sweet-a-kins
by Emerald Member on Sep. 4, 2013 at 9:58 PM
1 mom liked this
After watching I am Legend

Maybe this is the creation of the zombie apocolypse!! Lol


Quoting lga1965:

 Wow, isn't that interesting! I hope it is THE cure.


I wonder what the "anti-vax" groupies will say about this,though. Or the Fundies? Know what I mean?

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paganbaby
by Teflon Don on Sep. 4, 2013 at 10:05 PM
2 moms liked this

woohooThat is amazing! I hope this is the beginning of a cure!

la_bella_vita
by Bella on Sep. 4, 2013 at 10:05 PM

 WOW! Interesting, I've been wondering when this would come out.

paganbaby
by Teflon Don on Sep. 4, 2013 at 10:06 PM
1 mom liked this

Wouldn't my husband like that,lol.

Quoting sweet-a-kins:

After watching I am Legend

Maybe this is the creation of the zombie apocolypse!! Lol


Quoting lga1965:

 Wow, isn't that interesting! I hope it is THE cure.


I wonder what the "anti-vax" groupies will say about this,though. Or the Fundies? Know what I mean?


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kailu1835
by Ruby Member on Sep. 4, 2013 at 10:09 PM
2 moms liked this
I have a really hard time believing there were zero adverse affects. With every trial of every substance under the sun, there are at least a small handful of adverse reactions. So just based on that I have to question the validity of the study.

I wish they would look more at Olive Leaf extract combined with other natural supplements, that in singular studies have shown great potential towards reversing HIV all together. But they won't because they're natural ingredients that can't be patented and profited off of.
bozobean
by Bronze Member on Sep. 4, 2013 at 10:16 PM
That's awesome! I hope it turns out to be the cure.
TruthSeeker.
by Milami on Sep. 4, 2013 at 10:49 PM
No thanks.
MsDenuninani
by Silver Member on Sep. 5, 2013 at 12:35 PM

Really exciting news.

JakeandEmmasMom
by Platinum Member on Sep. 5, 2013 at 12:41 PM
What exciting news!
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