Aids Vaccine During Human Trials Failed

[Nienke]

http://timesofindia.indiatimes.com/India/H...how/2399834.cms

The world's most promising anti-AIDS vaccine candidate has failed. Instead of protecting volunteers from the deadly virus, the vaccine actually ended up infecting numerous participants during its large scale clinical trial on humans.

The vaccine also failed to reduce the amount of HIV in the blood of those who got infected, which was a second major goal of the study. US pharmaceutical giant Merck has now halted the V520 vaccine trial called STEP. The announcement came as a major blow to international hopes of developing a HIV vaccine that could stall the spread of this deadly disease.

Earlier experiments of the vaccine on animals and smaller tests on humans had showed promising results. This led Merck to start large scale human trials in US, Australia, Latin America and the Caribbean in 2004.

Over 3,000 high risk uninfected volunteers, aged between 18 and 45 years were recruited and three doses of the vaccine were injected over six months. The final result of the vaccine's efficacy was expected by the end of 2008. But initial analysis of 1,500 volunteers by the independent Data Safety Monitoring Board, monitoring the trial, concluded that the vaccine was failing hopelessly.

Of the 741 people who received at least one dose of the vaccine, 24 cases of infection were reported in 13 months. That compared with 21 infections out of 762 people who received injections of a dummy vaccine. The search to find an anti-AIDS vaccine has involved over 20 clinical trials with tests for over 30 vaccine candidates still under way.

Since HIV was first identified in 1981, 40 million people have been infected with the virus. Annually, an estimated 4 million new infections occur, of which 90% are in developing countries. Over the last 25 years, AIDS has claimed more than 25 million lives.

Merck Research Lab's president Peter Kim said: "We share in the disappointment of the research and HIV communities today."

[rak sa_ngop]

http://timesofindia.indiatimes.com/India/H...how/2399834.cms

The vaccine also failed to reduce the amount of HIV in the blood of those who got infected, which was a second major goal of the study.

Of the 741 people who received at least one dose of the vaccine, 24 cases of infection were reported in 13 months. That compared with 21 infections out of 762 people who received injections of a dummy vaccine.

Based on the results presented the statement that the vaccine "ended up infecting numerous participants" seems to be grossly misleading.

The cases of infection with or without the vaccine seem to be statistically pretty similar meaning that the vaccine probably just failed to have any positive effects.

[stevenjm]

Sad. A lot of people had their hopes pinned on it and the fact it may have led to a cure.

[Nienke]

Sad. A lot of people had their hopes pinned on it and the fact it may have led to a cure.

I definitely agree with that. Very sad!

[geriatrickid]

Couple points to keep in mind, because the news isn't all gloomy although a lot of the heavy hitters involved were deeply upset by the unexpected results. They have vowed to stay at it.

1. Vaccine was also being tested in South Africa with different results. The results seen here may be because the HIV present is a different subtype. This means that the underlying concept might still be of use. Unfortunately, because of the results, the SA trial is suspended too. (Ethical requirement that it be suspended - in the event of potential harm, must suspend for review.)

2. Vaccine was intended to boost CD4+ T cells with the goal to determine if an immune system response would protect against infection or control already occurring infection. It relied on a common cold virus used to introduce 3 manmade HIV genes. Vaccine format may need to be changed or more likely the genes.

Bearing in mind that the participants are selected from high risks groups, the 2.76% infection rate of those not vaccinated in the study group suggests that we are on the cusp of a major upswing in new infections. That in itself, should scare the crap out of people. The anticipated medical and economic costs to care for the sick is going to destroy some countries. That's sort of the good news in that it's a screaming alarm for the national MOH's to restart their awareness and prevention programs that were slashed over the years. A minister of health can't sit with this large number and not act accordingly.

[Prakanong]

Sad. A lot of people had their hopes pinned on it and the fact it may have led to a cure.

I definitely agree with that. Very sad!

How wrong can you be??????

This vaccine was a prophylactic vaccine not therapeutic

I am sorry but you seem to be posting vaccines stories without any basic knowledge - gross stupidity and misinformed

If you really want to know about vaccines I can arrange that!

[Nienke]

Sad. A lot of people had their hopes pinned on it and the fact it may have led to a cure.

I definitely agree with that. Very sad!

How wrong can you be??????

This vaccine was a prophylactic vaccine not therapeutic

I am sorry but you seem to be posting vaccines stories without any basic knowledge - gross stupidity and misinformed

If you really want to know about vaccines I can arrange that!

Ok, Prakanong, let me reprhase this: I agree on the fact that it is very sad that those who had hope are disappointed now. When I read the post I placed in the OP, also I thought 'd*mn, that's upsetting for a lot of people! That's what I meant with my reaction above. Sorry, I was not clear in this.

That you differ in opinion about the vaccine issue is no reason to become aggressive. It won't bring you any further, and with aggression you won't convince people of your own right or wrong.

Thank you,

Nienke

[Sheryl]

OK folks, truce.

Prakanong, while I agree that there were clearly inaccuracies in the post (inaccuracies on the part of the news report cited, not the OP's own), it is very impolite to label another person's post as "gross stupidity".

With respect to vaccines as well as a number of other health-related matters there are controversies and differing opinions. We're all entitled to our views. When a post conflicts with your own view or knowledge of facts, you're welcome to either ignore it or reply in a calm and factual way...but refrain from insults!

Putting aside my Moderator hat for a moment, as far as I can see the India Times clipping is very wrong in stating that the vaccine actually infected people, but otherwise accurate, i.e. the vaccine clearly did not work in the populations studied and the study has indeed been suspended.

[stevenjm]

Sad. A lot of people had their hopes pinned on it and the fact it may have led to a cure.

I definitely agree with that. Very sad!

prakanong - I can't understand your response. Is it that you cannot understand the above 2 quotes or are you saying something else?

[geriatrickid]

They are both right. Read the trial protocol. Primary intent is indeed prevention but secondary intent was validity as a therapy.

There are still ongoing trials in Thailand. 2 weeks ago in Pattaya. the Armed Forces Research Institute of Medical Sciences started recruiting 500 volunteers.

One must never lose hope.

[Prakanong]

They are both right. Read the trial protocol. Primary intent is indeed prevention but secondary intent was validity as a therapy.

There are still ongoing trials in Thailand. 2 weeks ago in Pattaya. the Armed Forces Research Institute of Medical Sciences started recruiting 500 volunteers.

One must never lose hope.

Recruiting for the Merck trial or another one? - I thought the Merck one was completely cancelled.

I found this one for the Armed Forces Institute

http://clinicaltrials.gov/ct/show/NCT00337...E5BB66E?order=1

[geriatrickid]

Prak, I apologize for the confusion. The intent of my post was to show that there is activity, i.e. new trials for different actives, not to state that the Merck trials would continue in Thailand. This was to illustrate the point that one should not give up hope because one trial didn't produce the hoped for results. Thank you for correcting this.

(I deserved a smack on the back of my head for that.)

[Prakanong]

Prak, I apologize for the confusion. The intent of my post was to show that there is activity, i.e. new trials for different actives, not to state that the Merck trials would continue in Thailand. This was to illustrate the point that one should not give up hope because one trial didn't produce the hoped for results. Thank you for correcting this.

(I deserved a smack on the back of my head for that.)

There are others in pre-clinical and even phase 1 as well.

Whenever I have heard people speak its unfortunatley 15-20 year cyclles unless a major technological breakthrough comes. Having said that though the past few years has seen a lot of breakthroughs, prophylactic cancer vaccines on the market, therapeutic cancer vaccines on trial. Malaria vaccine will be out in 3-4 years and hopefully Dengue not long after that.

On the other hand maybe we should listed to liar's, charlatans and plagarists like the Geier's and not have any vaccines?