HIV Vaccine - Human trials begun

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Justforfun000
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HIV Vaccine - Human trials begun

Post by Justforfun000 »

Here's hoping...

http://communications.uwo.ca/media/hivvaccine/
The University of Western Ontario presents: Schulich School of Medicine and Dentistry

Kang Lab |
Schulich School of Medicine & Dentistry |
Sumagen |
WorldDiscoveries

The first and only preventative HIV vaccine based on a genetically modified killed whole virus, developed by Dr. Chil-Yong Kang and his team at The University of Western Ontario, has received approval by the FDA to start human clinical trials.

HIV/AIDS Vaccine Developed at The University of Western Ontario Proceeding to Human Clinical Trials

London, ON – The first and only preventative HIV vaccine based on a genetically modified killed whole virus has received approval by the United States Food and Drug Administration (FDA) to start human clinical trials.

Developed by Dr. Chil-Yong Kang and his team at The University of Western Ontario, with the support of Sumagen Canada, the vaccine (SAV001) holds tremendous promise, having already proven to stimulate strong immune responses in preliminary toxicology tests with no adverse effects or safety risks. It is the only HIV vaccine currently under development in Canada, and one of only a few in the world.

“FDA approval for human clinical trials is an extremely significant milestone for our vaccine, which has the potential to save the lives of millions of people around the world by preventing HIV infection," says Kang, a researcher and professor at Western's Schulich School of Medicine & Dentistry.

Western President Amit Chakma says, "This joint venture between Sumagen and Western is a prime example of what collaboration between private industry and university researchers can achieve. Dr. Kang and his team are to be commended for their exceptional talent and remarkable persistence in developing a vaccine that addresses a tragic health crisis affecting millions of people around the globe."


Dr. Dong Joon Kim, a representative of Sumagen Co. Ltd. says, “Our company has committed substantial resources to this project since 2005 and we are very pleased to reach this milestone. It is our desire to continue growing our business in Canada and being a part of the business community in London.”

HIV/AIDS has killed more than 28 million people worldwide, and more than 35 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 commercialized vaccine has been developed 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 non-pathogenic and can be produced in large quantities.

Before it can be commercialized, the SAV001 vaccine must go through three phases of human clinical trials:

Phase I, set to begin in January 2012, will double check the safety of the vaccine in humans, involving only 40 HIV-positive volunteers.
Phase II will measure immune responses in humans, involving approximately 600 HIV-negative volunteers who are in the high-risk category for HIV infection.
Phase III will measure the efficacy of the vaccine, involving approximately 6,000 HIV-negative volunteers who are also in the high-risk category for HIV infection.

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.

Download high resolution photos
Dr. Kang Dr. Kang Dr. Kang


About Sumagen Canada

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.


About The University of Western Ontario

Located in London, Ontario, The University of Western Ontario is one of Canada’s leading research-intensive universities, committed to producing generations of talented leaders and innovations of national benefit and global value and significance.



Media contact:

Jeff Renaud, Sr. Media Relations Officer, The University of Western Ontario, 519-661-2111 ext. 85165 (office)



Note to media: The University of Western Ontario has a live television broadcast studio on campus.
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Re: HIV Vaccine - Human trials begun

Post by K. A. Pital »

This went completely unreported by the news today, at least on my side. Why? Seems to be rather important to me.
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Re: HIV Vaccine - Human trials begun

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I seriously hope this will work out and that we will eradicate HIV once and for all. It's caused so much human misery that it deserves nothing less.
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Re: HIV Vaccine - Human trials begun

Post by Ziggy Stardust »

Stas Bush wrote:This went completely unreported by the news today, at least on my side. Why? Seems to be rather important to me.
It is especially strange, since the news always seem to jump on and sensationalize various clinical trials for cancer treatments.
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Re: HIV Vaccine - Human trials begun

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Because HIV is no longer seen as a disease affecting people of priviledge, unlike cancer which targets everybody.

Plus, there's an election on.

Have a very nice day.
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Re: HIV Vaccine - Human trials begun

Post by Straha »

The title is misleading. There are HIV Vaccine trials going on around the country in a number of cities, and they've been going on for over a decade. This is the first trial that uses killed HIV virus isn't artificially made, so it could be more effective. Hopefully.


(I was actually rejected from an HIV vaccine trial where I live. :( )
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Re: HIV Vaccine - Human trials begun

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Doubled what Straha said. There has always been a vaccine trial going on, its just that most of the time, it ends up in failure. Cancer on the other hand "might" not...Probably an issue of public perception I guess
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Re: HIV Vaccine - Human trials begun

Post by Borgholio »

I am curious about how long the vaccine will work. As I always understood it, HIV is so nasty because it keeps mutating. It directly attacks the T4 cells and forces the immune system to adapt to it so often wears the system down and eventually allows other infections to show up. What's to prevent a new mutant strain of HIV from infecting someone protected by a vaccine made from a different strain?
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Re: HIV Vaccine - Human trials begun

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Another updated and more in depth look at the new vaccine hopeful:


http://www.medicalnewstoday.com/releases/252673.php
Human Clinical Trials Of HIV/AIDS Vaccine Making Steady Progress
Main Category: HIV / AIDS
Article Date: 13 Nov 2012 - 1:00 PST


The first and only preventative HIV vaccine based on a genetically modified killed whole-virus has been making steady progress in Phase I Clinical Trials in the United States and the interim results are being analyzed in preparation for the next steps.

Developed by Dr. Chil-Yong Kang and his team at Western University'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 currently under development in Canada, and one of only a few in the world. The first human applied clinical study (SAV CT 01) using a genetically modified killed whole-virus vaccine (SAV001-H) to evaluate its safety and tolerability was initiated in March 2012. This study is a randomized, observer-blinded, placebo-controlled study of killed whole HIV-1 vaccine (SAV001-H) following intramuscular (IM) administration. Infected 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.

Sumagen announced today that the patient enrollment has progressed smoothly and there have been no adverse effects observed including local reactions, signs/symptoms and laboratory toxicities after SAV001-H injection in all enrolled patients to date. With these interim results, the SAV001-H has proven safety and tolerability in humans and given Sumagen confidence for the next clinical trials to prove its immunogenicity and efficacy evaluation.

In addition, the humoral immune responses, such as HIV-1 antibody formation against SAV001-H, are currently being analyzed. The interim data showed significant increase in the HIV-1 antibody formations after SAV001-H administration compared to the base line in some patients. Even though this study is a blinded study until completion, these results are encouraging for the possibility of the prophylactic potency of SAV001-H.

With these interim results, Sumagen is confident of the safety of SAV001-H and the potency of inducing immune responses in human trials.

Dr. Dong Joon Kim, a spokesperson for Sumagen Co. Ltd. says, "We have proven that there is no safety concern of SAV001-H in human administration and we are now prepared to take the next steps towards Phase II and Phase III clinical trials. We are delighted to be one step closer to the first commercialized HIV vaccine."

In future, the company will be looking for collaboration with multi-national biopharmaceutical companies for globalizing clinical trials and commercialization.

This Phase I clinical trial (SAV CT 01) was partially funded by Industrial Research Assistant Program of National Research Council Canada since January 2012.

HIV/AIDS has killed more than 28 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 commercialized 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 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 U.S.
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Re: HIV Vaccine - Human trials begun

Post by ryacko »

Wait.... how do they know the HIV vaccine is successful?
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Re: HIV Vaccine - Human trials begun

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ryacko wrote:Wait.... how do they know the HIV vaccine is successful?
In human trials you give it to a subset of a population and see how many of those individuals vs the population as a whole become HIV+ over a certain time period. You'd try to give it to a high risk group if possible so it's easier and quicker to see if there's any difference.
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Re: HIV Vaccine - Human trials begun

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This report indicates that they are currently using already HIV infected individuals in the human trials.
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Re: HIV Vaccine - Human trials begun

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Max Wrote :
This report indicates that they are currently using already HIV infected individuals in the human trials.
Only for Phase 1. They want to be absolutely certain it's ok in humans and naturally they are trying it on people already positive for safety reasons. I am under the impression that even vaccines of this nature that involve the whole-virus are still impossible to be dangerous in the sense of "infecting" someone as it is a dead virus...but I guess they still want to see how the persons immune system and such will hold up.

Theoretically a strong immune response could also be induced in people already chronically infected and it could be as much a treatment as a preventative if we're in luck.
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Re: HIV Vaccine - Human trials begun

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Borgholio wrote:I am curious about how long the vaccine will work. As I always understood it, HIV is so nasty because it keeps mutating. It directly attacks the T4 cells and forces the immune system to adapt to it so often wears the system down and eventually allows other infections to show up. What's to prevent a new mutant strain of HIV from infecting someone protected by a vaccine made from a different strain?
Nothing, probably. But reducing the overall infection risk by a third or half would reduce the odds that any one person become infected, an slow overall disease spread for a while until the mutant strains got more common. If you use a whole killed virus, too, I'd imagine it gives the immune system a better chance of making its antibodies against a chemical target that is more highly conserved when the virus mutates.
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Re: HIV Vaccine - Human trials begun

Post by EnterpriseSovereign »

Hopefully this vaccine will turn out to be more effective than the last one to make the news several years ago, that one was around 30% effective. Of course, the whole usage of the placebo, while necessary is still ethically problematic. What is also in question is how to determine the level of exposure that each subject receives, presumably the sample size will be large enough to show a clear difference in infection rates (if any) between the two groups.
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Re: HIV Vaccine - Human trials begun

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EnterpriseSovereign wrote:Of course, the whole usage of the placebo, while necessary is still ethically problematic.
No it isn't, this is completely wrong. Here's how drug trials work: if a person is getting an alternate treatment for a chronic condition, the placebo group will receive just the standard course of treatment while the group receiving the new drug gets BOTH. That's how they get around the ethical problems with things like new treatments for auto-immune disorders for example.

However with vaccines it's even easier. The control group would get the best existing standard (aka nothing) while the other group gets the HIV vaccine. Since there is no current standard there is no ethical problem with going this approach at all.

EDIT: By the way, in drug trials that do involve an existing treatment, the treatments are GIVEN AWAY to people in the drug trial. This is a little known thing which is actually why a lot of people do drug trials--they aren't necessarily as interested in trying a new treatment but are very interested in getting their $50k a year Lupis treatments for free.
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Re: HIV Vaccine - Human trials begun

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Also, take into account that drug trials are supposed to find out if there are any horrible, debilitating, possibly deadly side effects to the treatment: that the control isn't getting the new experimental potentially killer treatment hardly seems so unethical after you consider that.
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Re: HIV Vaccine - Human trials begun

Post by Lord Falcon »

Excellent! Hopefully this will lead to a cure for HIV once and for all! I heard a rumor going around that broccoli may hold the key to curing cancer too. That would totally revise people's opinions of the vegetable. :)
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Re: HIV Vaccine - Human trials begun

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Broccoli is awesome. Most people just suck ass at preparing it.
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JULY 20TH 1969 - The day the entire world was looking up

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Re: HIV Vaccine - Human trials begun

Post by Marko Dash »

then dont, it's best raw
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Re: HIV Vaccine - Human trials begun

Post by EnterpriseSovereign »

Best for you raw, but the taste is the worst. That's the problem with vegetables like brocolli, cooking them or otherwise making them palatable often destroys any benefits they confer. Someone on a TV program said to get the benefits you needed to eat half a kilo of the stuff a DAY, to put that into context, the stuff you get from a shop is between 300 and 500 grams. That's an evening meal all by itself- I would welcome any way to make the stuff taste better without ruining the health benefits of eating it.
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Re: HIV Vaccine - Human trials begun

Post by Justforfun000 »

UPDATE:

This is very exciting too if it works as proposed.

http://www.inquisitr.com/493514/potenti ... cientists/
Potential AIDS Cure Discovered By Australian Scientists

Posted: January 24, 2013
Cure for Cancer and HIV may be on the way

A potential AIDS cure may be on the horizon after a discovery by scientists in Australia, and researchers at the Queensland Institute of Medical Research may have found a way to turn crippling HIV cells self-destructing using gene therapy.

The potential AIDS cure was initially pegged during research back in 2007 by Dr. David Harrich and his team, and the researcher, who has been working to unlock a cure for the disease for more than 20 years, tells the Australian Times:

“With money running out, I had my PhD student try one more experiment in late 2007. The experiment was to test if Nullbasic could render HIV non-infectious. The student came back and said it worked, so I told him to do it again and again and again. It works every time.”

According to the paper, the potential AIDS cure could work in such a way that the damaging virus is nullified and unable to replicate, halting the devastating effects the disease has on a sufferer’s immune system:

“By modifying the proteins that make up HIV into a mutated form, referred to as Nullbasic, Harrich’s research team have determined that it is possible to block the process of reverse transcription that allows HIV to damage the immune system. This would ultimately render the virus inert, preventing the condition of those infected with HIV from deteriorating further.”

AIDS in Africa can be a manageable epidemic, with proper resources

Harrich explains that the potential AIDS cure “instead of assisting the virus … actually impedes virus replication and does it quite strongly.”

The potential AIDS cure is set to be tested on mice in 2013, and clinical trials for the method could occur in the next ten years.

Read more at http://www.inquisitr.com/493514/potenti ... zcfvUZY.99
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Re: HIV Vaccine - Human trials begun

Post by Justforfun000 »

It just dawned on me though....would this render the person completely non-infectious? I'm guessing so from the sound of it but it's complicated....
You have to realize that most Christian "moral values" behaviour is not really about "protecting" anyone; it's about their desire to send a continual stream of messages of condemnation towards people whose existence offends them. - Darth Wong alias Mike Wong

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Re: HIV Vaccine - Human trials begun

Post by Dominarch's Hope »

Wasnt there a discovery in Upper Scandinavia/Russia of a genetic trait that made the person resistant or immune against HIV because the virus couldnt use the cells to reproduce?

This

http://www.wired.com/medtech/health/new ... ntPage=all
Med-Tech : Health
Genetic HIV Resistance Deciphered
Randy Dotinga 01.07.05
Throughout the history of the AIDS epidemic, a few lucky people have avoided infection despite being exposed again and again. Now, researchers are traveling back in evolutionary time to understand why some people are resistant -- and in some cases virtually immune -- to the AIDS virus.

Studies released this week and last year suggest that the roots of AIDS immunity extend back for centuries, long before the disease even existed. Our ethnic backgrounds and the illnesses suffered by our distant ancestors appear to play a crucial role in determining whether our genes will allow HIV to take hold in our bodies.

For now, the findings seem likely to inspire more raised eyebrows than cutting-edge drugs. But over time, the research into why some people don't get HIV may help doctors treat those who do. By understanding which genes help people fight off infection, "we might move to a time where we can make more refined decisions about timing or intensity of therapy. Now, it's like a glove where one size fits all," said Dr. Matthew Dolan, an AIDS specialist in the U.S. Air Force and co-author of a new AIDS genetics study in an online edition of the journal Science.

Genetic resistance to AIDS works in different ways and appears in different ethnic groups. The most powerful form of resistance, caused by a genetic defect, is limited to people with European or Central Asian heritage. An estimated 1 percent of people descended from Northern Europeans are virtually immune to AIDS infection, with Swedes the most likely to be protected. One theory suggests that the mutation developed in Scandinavia and moved southward with Viking raiders.

All those with the highest level of HIV immunity share a pair of mutated genes -- one in each chromosome -- that prevent their immune cells from developing a "receptor" that lets the AIDS virus break in. If the so-called CCR5 receptor -- which scientists say is akin to a lock -- isn't there, the virus can't break into the cell and take it over.

To be protected, people must inherit the genes from both parents; those who inherit a mutated gene from just one parent will end up with greater resistance against HIV than other people, but they won't be immune. An estimated 10 percent to 15 percent of those descended from Northern Europeans have the lesser protection.

Using formulas that estimate how long genetic mutations have been around, researchers have discovered that the mutation dates to the Middle Ages. (Similar research in mitochondrial DNA -- passed along by women -- has suggested that Europeans are all descended from seven Ice Age matriarchs.)

Why would the mutation stick around so long instead of giving up the ghost? Researchers initially thought the mutation provided protection against the bubonic plague that caused the Black Death in Europe. Those with the mutation would have lived longer and had more children while many of their neighbors died off. The fact that the genetic mutation also provided protection against HIV centuries later would just be a coincidence.

The plague scenario has been largely discarded in favor of another deadly scourge. "A disease like smallpox that has been continuous since that time ... is more likely," said Yale University professor of epidemiology Alison Galvani, who co-wrote a study about the possible smallpox link in 2003.

According to Galvani, while the plague came and went, smallpox stuck around well into the 20th century, providing even more incentive for a protective gene to live on: It would keep people alive generation after generation, instead of just during one brief epidemic.

There are other cases of genetic mutations affecting two diseases: People who inherit one of the two mutations necessary to develop sickle-cell anemia end up with extra resistance to malaria, said Dr. Donald Mosier, professor of immunology at The Scripps Research Institute in La Jolla, California.

Last February, Mosier co-wrote a report in the journal Nature that debunked the plague theory after researchers found that mice bred with the AIDS-protective gene mutation still got sick with the plague. Mosier's not quite sure smallpox deserves credit for extending the mutation's life either, however, and suspects that a less high-profile disease -- diarrhea-causing dysentery -- may be why the mutation has lived on.

Besides the Northern Europeans and Central Asians with the CCR5 receptor gene mutation, new research shows that members of several ethnic groups have another, less-powerful kind of AIDS resistance. In the Science study released this week, a large team of investigators report that people who have more copies of a specific gene end up with greater resistance to AIDS, in some cases significantly changing how they handle getting infected.

The researchers examined the number of copies of a gene known as CCL3L1 in 4,300 people -- some HIV-positive, some HIV-negative. Those with the most copies of the gene -- but only as compared with others in their ethnic group -- had the most immunity to HIV. The HIV-positive people with the fewest gene copies got sick as much as 2.6 times faster than others who were infected.

More copies of the CCL3L1 gene appear to translate into more proteins known as cytokines, which guide immune cells by latching onto receptors -- those cellular locks. The cytokines "tell inflammatory cells it's time to move and go somewhere," Mosier said. With more cytokines floating around gumming up the cellular keyholes, there are fewer locks for the AIDS virus to pick.

Compared with the almost-absolute protection afforded by the gene defects in Europeans, "the effect is not as complete, but the prevalence is much higher," said study co-author Dr. Sunil K. Ahuja, professor of medicine at the University of Texas and director of the Veterans Administration Center for HIV and AIDS in San Antonio.

What can scientists and doctors do with all this information? Doctors could potentially test AIDS patients to see if their genes make them especially vulnerable to progression of the disease, Ahuja said. "This hasn't happened yet, and we aren't there yet. But that would be some practical downstream value of the work we are doing."

Then there's the prospect that people will use genetic testing as a ticket to a carefree sex life. If you're naturally resistant to AIDS, why not dump the condoms and add a few notches to your bedpost?

The Scripps Research Institute's Mosier has gotten calls from curious citizens wondering about their genes. But don't go running to your nearest genetic laboratory just yet. For one thing, researchers aren't sure whether the protective genes both giveth and taketh away: Perhaps they make people more resistant to AIDS but also make them more vulnerable to other germs.

Then there's the pesky matter of the few people who have gotten infected with HIV even though they're supposed to be immune. "It's extremely rare," Mosier said, "but you don't want to tell people they'll be protected and then have them change their risk behavior and get exposed."
Its apparently just extra resistance/occasional immunity. I heard about some gene therapy related to this.
Because, Murrica, thats why.
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Justforfun000
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Re: HIV Vaccine - Human trials begun

Post by Justforfun000 »

Fascinating article. I can see now how this led them down the road...but it looks like the OP is even more intriguing...IF they can replicate the preliminary results in a way even close to what they are hoping...individually this could be as good as a cure. It'd be identical to a gene therapy that prevented Shingles, Herpes and other viral outbreak related conditions to become problematic in the first place.

Ironically the virus itself is relatively benign if it's latent. They could theoretically keep it that way and render anyone living with HIV non-infectious to others. In theory. At least that's what I'm gathering. Pretty cool!
You have to realize that most Christian "moral values" behaviour is not really about "protecting" anyone; it's about their desire to send a continual stream of messages of condemnation towards people whose existence offends them. - Darth Wong alias Mike Wong

"There is nothing wrong with being ignorant. However, there is something very wrong with not choosing to exchange ignorance for knowledge when the opportunity presents itself."
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