A World First: Vaccine Helps Prevent Hiv Infection -produced In Bangkok!

[Chunkton]

When I saw the headline I thought it was a Thai breakthrough, and thought wow, but it is just The US or UN (the story isn't clear) testing vaccines on poor people in 3rd world countries. Were they paid? People who will never have a civil suit or class action if it went wrong. Nor in the future if there are side effects. Shameful.

[webfact]

Thai-American AIDS vaccine trial cuts risk of infection for first time

BANGKOK, Sept 24 (TNA) – Announcing significant breakthrough in the war against HIV-AIDS, an experimental AIDS vaccine achieved through Thai-American cooperation is now considered having effective potential to cut the risk of infection by about 31 per cent, Thailand’s Minister of Public Health Witthaya Kaewparadai said on Thursday.

The Thai minister spoke to a news conference here with United States ambassador to Thailand Eric G. John that researchers from both countries have spent six years in the third-phase AIDS vaccine experiment, conducting the world's largest vaccine trial on 16,402 HIV-negative Thai volunteers living in the seaside provinces of Rayong and Chonburi.

The first phase, carried out with a small group of volunteers, tested whether the candidate vaccines were safe. The second phase used a larger group of volunteers is to determine whether the candidate vaccines stimulated the immune system. The results from these studies showed the two candidate vaccines to be safe and immunogenic, supporting the continuation of research in Phase III to test whether the candidate vaccines can provide infection protection in real life settings.

Mr Witthaya said that a two-vaccine injection combo, ALVAC-AIDSVAX, had been administered to the volunteers six times.

The test results showed that the vaccine can prevent the risk of becoming infected with HIV at a certain level, 31.2 per cent, said the Thai minister, adding that this is the world's first potential AIDS vaccine trial.

Mr Witthaya, however, cautioned that the vaccine cannot yet be used as it can still does not decrease the amount of viral infection in the bloodstream and that the researchers are planning to conduct further studies and experiments to top this initial success.

Shortly after the announcement, the World Health Organization and the Joint UN Programme on HIV/AIDS issued a statement hailing the study results as "the first demonstration that a vaccine can prevent HIV infection in a general adult population and are of great importance."

The two UN agencies, however, noted that further studies would have to be taken to ensure that such a vaccine would work against other strains in many parts of the world. (TNA)

-- TNA 2009/09/24

[britmaveric]

^It was voluntary. Jeez some people will knock anything.

[tig28]

Vaccines routinely kill people

Homeless people die after bird flu vaccine trial in Poland

http://www.telegraph.co.uk/news/worldnews/...-in-Poland.html

Right on teatree!!!

Just don't try to sell this to the countless millions who are alive and well ------free from Polio, Smallpox, Tuberculosis, Whooping cough , Diphtheria, Tetanus, Hepatitis, Rubella ......... etc. etc.....

And by the way--- the most deadly element on earth is dihydrogen monoxide and many countries are producing and using it in huge quantities!!

Link :http://www.dhmo.org/facts.html

Edited September 24, 2009 by tig28

[geriatrickid]

I love the spin control on this study. There was also a failure that is being glossed over.

1. The clinical trial failed because the vaccine had no effect on the amount of virus in the blood of volunteers who acquired HIV infection during the study. (That's not a bad failure as it was sort of expected, but you have to try.) So the vaccine cannot be used as a treatment. However, the vaccine was pushed as a possible treatment.

2. It was a success as a vaccine trial because it is statistically significant. (see below)

The U.S. Army Surgeon General picked up the bill on this one. Yup, those evil blood thirsty american barbarians paid for everything while the "greedy" pharma companies donated the stock and support staff. Congrats to lead investigator Supachai Rerks-Ngarm, M.D., of the Thai Ministry of Public Health’s Department of Disease Control for jumping through hoops to get this done. FYI there were 2 pharma companies involved; GSID is a non profit pharma company and sanofi has some of the best state of the art vaccine development technology out there. Both pharma companies put alot of resources into this with there being a minimal opportunity for a big payout anytime soon. There was no UN funding. (Maybe if they had made i an anti US/UK/Israel study the UN would have funded )

Numbers are significant because it enrolled 16,402 men and women ages 18 to 30 years old at various levels of risk for HIV infection. There was a difference in the infection rates;

74 of 8,198 placebo recipients - HIV+

51 of 8,197 participants -HIV+ who received the vaccine regimen

This level of effectiveness in preventing HIV infection was found to be statistically significant. It is significant enough to suggest more work is justified.

The clinical trial went through multiple ethics reviews, so it cannot be questioned on that. The reviews are thorough and when the gov't health units are involved, they do not screw around. U.S. Army Surgeon General's office is known to follow the rules (unlike alot of university researchers who bend them.)

Although the RV144 clinical trial is exciting, the discovery of 2 new antibodies is even more exciting.

If you want the scoop on the trial and other amazing stuff check out http://www.hivresearch.org/

And here's a piece of trivia: When HIV research was hit hard during budget cuts, it was the U.S. military that dug deep to find ways to help out. It may surprise people to know that some of that massive U.S. military budget goes into R&D for water purification technology, nutrition and infectious diseases.

Edited September 24, 2009 by geriatrickid

[TAWP]

When I saw the headline I thought it was a Thai breakthrough, and thought wow, but it is just The US or UN (the story isn't clear) testing vaccines on poor people in 3rd world countries. Were they paid? People who will never have a civil suit or class action if it went wrong. Nor in the future if there are side effects. Shameful.

The reasons they are doing it here is NOT because they would be able to get away scot-free. Read all the linked articles...

[Jingthing]

^It was voluntary. Jeez some people will knock anything.

Yeah, you could tell some people they just won the Big Lotto, and their first reaction would be to whine about the taxes.

[pedro01]

The results were part of the HIV Vaccine Trial Phase III on 16,402 Thai volunteers in Chonburi and Rayong provinces. Half of the volunteers were given the RV 144 vaccine in 2006, and the other half received placebos.

Of those who got placebos, 74 became infected, while only 51 of those who got the vaccines did.

Well I admit it's been decades since I studied epidemiology and statistics but those results just don't seem significant to me.

My thoughts exactly.

[Scott]

Hopefully some of the medically more knowledgeable posters will come in and explain this (Geriatrickid, where are you).

There are a lot of different strains of HIV and Thailand as I understand it has a more consistent strain that some other places, thus, it would be hard to know if the vaccine is effective on some strains or no strains.

This is at least a start. It's been a long time since there has been much of a significant breakthrough in HIV prevention.

The thing to remember is that people have sex. For all kinds of reasons, many don't/can't have safe sex. Rape victims, for example, aren't given much choice.

[Jingthing]

The CNN doctor reporter is saying what is really different about this test is that they gave so many vaccine shots (six I think) to each person. It is the first trial that has showed any promise at all. They are hopeful they can expand on what they learned and improved the results. So there is some hope for a vaccine now where before today there really wasn't any reasonable hope.

[Bagwan]

A World First: Vaccine Helps Prevent Hiv Infection -produced In Bangkok!

Really? Where does it say that the vaccine was produced in Thailand? What input other than providing the guinea pigs has Thailand made? Is this yet another load of credit claiming BS from a Thai government? Surely all the kudos should be directed at the US Army and the two European drug companies.

I was told only last week by one who would certainly know that there are only about 14 doctors in LoS with the knowledge and competence to deal effectively with HIV and AIDS patients. Would a government spokesman care to make a statement on this shameful state of affairs?

[Scott]

Geriatrickid--sorry, I didn't see that you had already posted. Your post is most informative and helpful. Thanks.

[iainiain101]

Out of 16,402 volunteers, 125 became HIV infected.

Thats 0.762%.

Does that imply that 1 in 131 Thais will contract HIV over a 3 year period?

This may sugest that the volunteers work quite close to the sex trade?

[Rumfoord]

"This result is tantalisingly encouraging. The numbers are small and the difference may have been due to chance, but this finding is the first positive news in the Aids vaccine field for a decade," said Dr Richard Horton, editor of the Lancet medical journal.

A difference of just 23. Just "noise". How many of the volunteers changed their life styles in the 3 years of this trial?

can you spot the difference?

the source for booth pie charts: http://news.bbc.co.uk/2/hi/health/8272113.stm

[Johpa]

I can't even spell epidemiology but as far as statistics is concerned you are right. It is not "statistically significant"

Thailand can't yet claim the hub of scientific discoverries. Nice try I suppose but mathematicains would not buy it.

Uh, perhaps there is a correlation between poor spelling and a poor understanding of statistics. A 31% increase in prevention in a phase III study is significant in any mathematician's book. Look at the large size of the population under study and not the numbers of infected participants. In a study of that size, if the drug had no effect then one would expect nearly identical numbers of infected patients at the end of the study. Again, they are talking about statistical significance; they are not talking about having found a magic bullet like the Salk polio vaccine. If I were in a high risk group and had the option to take a drug that seemed to offer a 31% increase in protection, then I would jump at such an opportunity.

[wasabi]

While not purely random results these don't seem statistically significant to me. Not everyone who encounters HIV will catch it and it's hard to say how many on both sides actually encountered the virus. I do hope it's the good news everyone wants to hear but I'd rather see better numbers before getting excited.

[webfact]

VACCINE BREAKTHROUGH

Aids vaccine shows results

By Pongphon Sarnsamak

The Nation.

Published on September 25, 2009

Aids vaccine shows results

Thai trial shows modest results for the first time anywhere

The world's largest HIV/Aids vaccine trial - conducted in Thailand over the last several years - shows that it's now possible to produce a powerful prevention against the viral killer.

"The outcome represents a breakthrough in HIV vaccine development because for the first time ever there is evidence that an HIV vaccine can be effective," Public Health Minister Witthaya Kaewparadai said yesterday.

However, while the Phase III trial, carried out jointly by the US military and Thai scientists, found that the experimental vaccine is 31.2percent effective in reducing the risk of infection, it failed to reduce the HIV virus in the blood of infected persons.

Dr Suppachai RerkNgam, project director for Thailand's Phase III HIV vaccine clinical trial, said researchers aimed to achieve a 50percent efficacy rate, but the outcome was less at 31.2 per cent.

"Although it's not high enough for use just yet, this is significant evidence that can lead to higher vaccine efficacy in the future. Whether the vaccine will be licensed, or what further studies need to be done, data will be considered thoroughly by Thai and international experts," he said.

Colonel Jerome Kim of the US military's HIV research programme said via a video link that there could be an effective vaccine in the near future.

"This was a turning point for the perspective of vaccine research," he said. "I believe that from now scientists around the world will convene and discuss among each other on how to develop the next generation of HIV vaccine in the future."

The Thai experiment, known as RV 144, tested the "primeboost" combination of two vaccines: ALVAC HIV vaccine (the prime) produced by SanofiPasteur, and AIDSVAX B/E vaccine (the boost) produced by the Global Solutions for Infectious Diseases.

This combination was based on an HIV strain that commonly circulates in Thailand.

The RV 144 was designed to test the vaccine strategy's ability to prevent HIV infection, as well as its ability to reduce the amount of HIV in the blood (viral load) of those who became infected after they enrolled in the study.

The Public Health Ministry conducted the study, which was sponsored by the US Army Surgeon General with US$105 million (Bt3.5 billion), while Mahidol University and the Armed Forced Research Institute of Medical Science, operating out of Thailand, helped to conduct the trial.

The Phase III vaccine study was launched in 2003 and involved 16,402 noninfected volunteers aged between 1830 years, at average risk of HIV infection. Half of them received the primeboost vaccine combination and half received a placebo.

The vaccinations ended in July 2006, and the volunteers took a HIV test every six months for three years.

They received counselling on how to prevent infection with HIV at the beginning of the study and every six months after the start of the trial, for a total of three and a half years.

The International Data and Safety Monitoring Board did not identify any safety concerns after they met eight times since the trial's inception.

The study vaccines did not cause HIV infection because they are not made from and do not contain the entire virus, either live or killed.

-- The Nation 2009/09/25

[jonclark]

I can't even spell epidemiology but as far as statistics is concerned you are right. It is not "statistically significant"

Thailand can't yet claim the hub of scientific discoverries. Nice try I suppose but mathematicains would not buy it.

Uh, perhaps there is a correlation between poor spelling and a poor understanding of statistics. A 31% increase in prevention in a phase III study is significant in any mathematician's book. Look at the large size of the population under study and not the numbers of infected participants. In a study of that size, if the drug had no effect then one would expect nearly identical numbers of infected patients at the end of the study. Again, they are talking about statistical significance; they are not talking about having found a magic bullet like the Salk polio vaccine. If I were in a high risk group and had the option to take a drug that seemed to offer a 31% increase in protection, then I would jump at such an opportunity.

Yep a 31% increase is a big increase - Would't we all be much happier if we woke one morning and found the old John Thomas had inceases over night by a whopping 31% - The missus would be pleased!

Seriously though the arsenal of ARV is increasing, resulting in HIV becoming a chronic rather than a death sentence in developed countries, although many African countries unfortunatly lag way behind. This trial shows for the first time that a vaccine can and does work, it may not be perfect but it is ground work on which to build and develop future trials and vaccines. How many times did Edison fail before he made a working light bulb??

Come on TV members after all the bulls**t that has come out of Thailand in the past few years this is great news which is but a part of a small but possibly significant step in moving one step closer to eradicating a disease which has claimed millions of lives of the poorest and most vunerable people in the world.

Congratulations to all involved especially the volunteers for having the courage to participate.

[caf]

The results were part of the HIV Vaccine Trial Phase III on 16,402 Thai volunteers in Chonburi and Rayong provinces. Half of the volunteers were given the RV 144 vaccine in 2006, and the other half received placebos.

Of those who got placebos, 74 became infected, while only 51 of those who got the vaccines did.

Well I admit it's been decades since I studied epidemiology and statistics but those results just don't seem significant to me.

My thoughts exactly.

Why the spin on Thaivisa? The Thais have a world first????

The Lancet have said "The numbers are small and the difference may be due to chance"

It is not a statistically significant fnding though a step in the right direction. I hope a cure will be found. But guys, don't try and defend poor research by saying it is not a vaccine ( which in fact it is) and ignoring the stats

But as I say something positive - largely it seems thanks to the US who got no credit in the original post. Well TIT

Edited September 25, 2009 by caf

[caf]

I can't even spell epidemiology but as far as statistics is concerned you are right. It is not "statistically significant"

Thailand can't yet claim the hub of scientific discoverries. Nice try I suppose but mathematicains would not buy it.

Uh, perhaps there is a correlation between poor spelling and a poor understanding of statistics. A 31% increase in prevention in a phase III study is significant in any mathematician's book. Look at the large size of the population under study and not the numbers of infected participants. In a study of that size, if the drug had no effect then one would expect nearly identical numbers of infected patients at the end of the study. Again, they are talking about statistical significance; they are not talking about having found a magic bullet like the Salk polio vaccine. If I were in a high risk group and had the option to take a drug that seemed to offer a 31% increase in protection, then I would jump at such an opportunity.

Sorry. disagree. Perhaps a re read of a good stats book would not be amiss. With respect

[roiethome]

whilst I agree this is a major step forward, I think the results show that it is too soon to throw away the condoms and start sharing needles with strangers, as there is still a high chance of becoming infected even after taking the vaccine.

If so, what is the point of releasing this information with such banner headlines now. I would not sign up for something which is so low a success rate. Surely they should wait until it is 100% effective and then we can go back to how it used to be before this epidemic started.

[Scott]

At this point, it is a trial. I don't believe there is any plan to release this vaccine.

Releasing the information, however, may spur further R&D as well as see funding restored to programs.

And finally, it's news. Not necessarily the best news, but it's newsworthy none-the-less.

[eggomaniac]

It is a start, I suppose,

BUT what about the other 69% who still contracted the disease?????????

NOT 69%....

Actually less than 1% of ALL the volunteers developed AIDS.

The CONTROL group 0.6% - The PLACEBO group 0.9%

--------------

The TEST would have to be run at least 2 more times before it is given some weight, especially when the vaccine used was a combination of 2 disproven vaccines, NOT some new discovery.

Apparently the PLACEBO group did better than the Thai National average 1.4% by 0.5%.

{2007 statistcs Below}

They SOULD have run the test in some of those African countries where the Rate is ONE IN FOUR!!!! Thailand is barely in the top 50 for frequency.

https://www.cia.gov/library/publications/th...r/2155rank.html

Okay LAST edit LOL The newscast I saw said, as a Discalimer, this was only tested on the Asian HIV virus.

They said there are 3 or 4 strains in the World. [didn't know that]

Edited September 25, 2009 by eggomaniac

[nidhogg]

I can't even spell epidemiology but as far as statistics is concerned you are right. It is not "statistically significant"

Thailand can't yet claim the hub of scientific discoverries. Nice try I suppose but mathematicains would not buy it.

Uh, perhaps there is a correlation between poor spelling and a poor understanding of statistics. A 31% increase in prevention in a phase III study is significant in any mathematician's book.

Well, I am not a mathematician, and I do have bad spelling - however, I once saw a cartoon program about statistics, so I will have a go. Simply using a Chi squared test on the numbers presented (that cartoon was fairly detailed) gives you a bare level of significance that indicates that there is a 1 in 20 chance of the numbers falling that way by random chance.

Now, as it was quite a long cartoon, it also mentioned multiple regression analysis which is a statistical tool for dealing with lots of variables. So, whats the odds that putting in data on participants sex, age, sexual orientation and drug use habits (to name a few) and still ending up that the vaccine is a significant independent variable? - small, would be my guess, very very small.

Think I will keep the condoms handy for a bit longer.

[TAWP]

It is a start, I suppose,

BUT what about the other 69% who still contracted the disease?????????

NOT 69%....

Actually less than 1% of ALL the volunteers developed AIDS.

The CONTROL group 0.6% - The PLACEBO group 0.9%

Conracted HIV, not developed AIDS.

The TEST would have to be run at least 2 more times before it is given some weight, especially when the vaccine used was a combination of 2 disproven vaccines, NOT some new discovery.

Apparently the PLACEBO group did better than the Thai National average 1.4% by 0.5%.

The reason is due to the campaign also containing information of safe sex, including pushing for usage of condoms etc.

And yes, as someone mentioned, the location of the trial indicates there were a fair number of late night establishment workers in this trial.

Not sure if professions of trial subjects are indicated in the documentation.

[eggomaniac]

There is no cure for HIV, only treatment. What's scary? They chose a high risk population who just continued to live their lives as they would have anyway.

The Op is saying there is a cure. "an experimental vaccine has prevented infection with the AIDS virus"

BTW I hope a cure will be found

For the record > He did NOT. A cure for a disease and a vaccine to prevent a disease are 2 different animals, NOT a ping pong game, as you suggest.

I do agree, and the news reports state, that these 'findings' will require many years of verification before a vaccine, like polio vaccines, can be administered to everyone in the World to stop the spread of AIDS, [until it morphs]. The news reports actually stated to NOT get this confused with a cure and that it holds no hope for those who are already afflicted and the OP did use the language suggesting a cure.

As for the "Thai discovery" part, it was some Army guy, Thai or American I'm not sure, who decided to run the study with 2 vaccines that had previously been proven useless.

I can't find whether one or more of those 2 vaccines had been developed in Thailand, but suppose NOT.

If a Thai Army guy decided to throw those 2 together and it leads to a vaccine for our grandchildren and wipes out AIDS, he definitely should recognition, albeit posthumously!

I, for one, believe this study, out the $65,000,000,000 [yes that is billions] that has been spent on this disease, falls into the 'anomaly' factor; meaning out of the dozens and dozens of similar studies, you have to get one that burps at you.

The REAL medical story are the World diseases that kill way more People on the Planet than AIDS and get a SMALL % of the attention and FUNDING they throw at AIDS.

One HAS to laugh. Canada is stopping Tami flu vaccination because a recent 'study' showed it increases the risk for Swine flu.

[jonclark]

For those of you who are interested New Scientist has an interesting article in a Q and A form. It's pretty good and easy to read without too much technical jargon

link here

http://www.newscientist.com/article/dn1784...ne-triumph.html

[Payboy]

produced In Bangkok!

Seriously?

[BlackJack]

There is only ONE product that is 100% effective in preventing AIDS, Herpes, HPV.

Just this week a little know Australian company was approved USA patents until 2024. They also have patents in 26 other countries.

They have gone through the hard slog of phase 1 2 3 trials and have FDA fast track approval. The product is ready for release and has binding contracts in place with large pharmas and the Worlds leading condom maker. (I was going to say largest but as this is a serious subject I resisted ).

The news out of Thailand seems to be research fodder news and the product maybe years away from the market as it needs to go through all the PROPER internationally recognised trials. Particularly with its efficacy.

Some comments i received from people in the front line of research in the USA state that any vaccine would be 5- 7 years away.

If you remember in the late 80's they said a vaccine would be available in 2 years. Now 20 plus years on still no vaccine.

A vaccine that would be only 30% effective could be viewed as dangerous as the virus by its very nature adapts and survives. To set off a man made change via a vaccine could prove to be more of a pandora's box than a fix. Particularly if the military is involved.

I am all for a cure in whatever shape or form but i wont be lining up for a jab - same for swine flu.

[Scott]

I post removed for flaming. Warnings will be issued if this goes off-topic. Discussion and disagreement are welcomed, but keep it from getting personal.