Experimental AIDS Vaccine Fails Crucial Experiment

AP:

A promising experimental vaccine to prevent the AIDS virus has failed in a crucial experiment, with volunteers becoming infected with HIV anyway, leading the drug developer to halt the study.

Merck & Co. said Friday that it is ending enrollment and vaccination of volunteers in the large international study, which is partly funded by the National Institutes of Health.

It was a significant setback in the daunting quest to develop a vaccine to prevent AIDS. Merck's vaccine was the farthest along and was closely watched by experts in the field.

Read the whole story: AP

Comments

[factanonverba]

04:23 PM on 09/24/2007

Here's the copy of the letter I received as a study participant announcing the end of the study.

Dear Step study participant,

This letter is to inform you that further vaccinations in the Step study have been stopped.

Like many clinical trials, our study is monitored by a Data & Safety Monitoring Board (DSMB). This board is a committee of clinical trial experts, statisticians and ethicists. Review by the DSMB is a regular part of clinical trial monitoring and its members see data that shows who is receiving study vaccine and who is receiving placebo.

At a planned meeting on 18 September 2007, the DSMB for the Step study reviewed data from the study and concluded that the study would not be able to show efficacy of the vaccine. The DSMB therefore recommended that further vaccinations be stopped in the study, because it would not meet its efficacy endpoints, and the study sponsors and Protocol Team leaders agreed with this recommendation.

The vaccinations are being stopped because the vaccine did not show efficacy. The Step study was designed to look at 2 questions related to efficacy:

1. Does the vaccine prevent HIV infection? and
2. Does the vaccine reduce the amount of virus in people who were vaccinated and then later develop HIV infection?

A planned “interim” analysis of data that answer these questions showed disappointing results. The analysis compared results in people who got the vaccine to results in people who did not get the vaccine. The vaccine did not reduce the incidence of HIV infection and did not reduce the amount of virus in people who became infected with HIV.

We would like you to remain in the study so that we can continue to monitor aspects of your health and your immune response to the study vaccine. You will not receive any more injections. Your study visits will continue with the same procedures that we told you about in the study informed consent form.

Thank you for being part of the Step study.

Sincerely,

Susan Buchbinder, MD Jonathan Fuchs, MD
Principal Investigator Co-Principal Investigator

[factanonverba]

05:39 PM on 09/22/2007

I participated in this study and they are taking care of me well. I don't want to post the particulars nor do I know if I received the vaccine or the placebo but I did receive two injections out of the three and have been given bimonthly check-ups. It is regrettable that this vaccine did not work and though I am often skeptical of big pharma on this I have no complaints.

[dora rice]

04:48 PM on 09/22/2007

though shall not fricken si in the arsenal.

[dora rice]

04:45 PM on 09/22/2007

what happens now to the people they gave AIDS to, with their magic hocus bocus vaccine

[johnnyjust]

04:27 PM on 09/22/2007

Prevention is the best cure.

According to the CDC, the overwhelming majority of aids cases still come from male-to-male homosexual sex.

Why is this fact almost never mentioned in articles such as these or Hollywood Aids events or Aids Walks, etc.?

Too much on the personal responsibility side?

[Qbear]

05:32 PM on 09/22/2007

Because it's a GIVEN that the gay community knows it is at risk. You can thank the Christian fundies there is no mention of GAYS with AIDS literature. They banned gay content.

[Qbear]

05:34 PM on 09/22/2007

According to the CDC, the overwhelming majority of aids cases still come from male-to-male homosexual sex.

NOT Globably Heterosexual transmission is the highest new cases.

[johnnyjust]

07:47 PM on 09/22/2007

You are wrong, PuffPost breath.

That global warming you hear about is four globes touching.

Aids still caused mainly by male homosexual sex.

Don't you want the truth? Don't worry, gays still won't embrace personal responsibility.

[Qbear]

03:40 PM on 09/22/2007

If you test positive, they pump you full of chemotherapy, and your immune system fails

They do not pump HIV+ prople with chemotherapy...What most of you folks DON'T know about AIDS would fill the library of Congress.

GET INFORMED
http://www.thebody.com/

http://www.webmd.com/hiv-aids/default.htm?ecd=ppc_google_worldaids_sexualhealth_hiv_search&gclid=ci_jpelo144cfsbugaoddwhz5a

[marlowe]

02:28 PM on 09/22/2007

AND STILL... with all the things that can trigger false positives (flu, pregnancies), no one ever stops to wonder if the TEST, itself, is part of the problem.

If you test positive, they pump you full of chemotherapy, and your immune system fails (just like AIDS!).

Interesting coincidence.

[Qbear]

03:06 PM on 09/22/2007

NO dimwit, long before there was an AIDS test Thousands had died of AIDS.

[noamjunior]

12:05 PM on 09/22/2007

I got nothing against big Pharma
I just don't think they should be in charge of regulating themselves or writing the laws that regulate them

[Ginzaman]

12:47 AM on 09/22/2007

I don't know which AP photographer took this picture. But doesn't that perfectly capture how f****d over people of color have been by Bush and the neocons? First, it Reagan and flood South Central L.A. with coke. Now Bush and Huckabee saying forget condoms. What's next?

[Qbear]

12:40 AM on 09/22/2007

I've seen at least a dozen HIV/AIDS vaccine attempts fail. Each is disappointing. They aren't developing NEW drugs to treat HIV under Bush it's been PITIFUL, compared to all the advances under Clinton. I'm alive today due to the Drugs developed under Clinton, in 1996 I had 12 t-cells, Normal immune systems have 1200-1500 t-cells. A friend of mine also survived, and he could no longer digest food and was being fed through a hep-port in his chest.

[1will]

12:54 AM on 09/22/2007

I didn't know that Bush and Clinton actively worked on AIDS vaccines. I just thought they were presidents.
Considering the AIDS treatments you talk about were brought about by the drug companies, not government, your claims are a bit weak.

[Qbear]

01:46 AM on 09/22/2007

Clinton got drugs FAST TRACKED, so there is something a president can do, at least a competant president.

[Qbear]

01:47 AM on 09/22/2007

Drugs especially drugs for this pandemic are financed by the government.

[TheMadScientist]

02:00 PM on 09/22/2007

Oh, please. Spare me. The single largest expenditure on the NIH budget in terms of a single grant for the last 3 years has been this very AIDS vaccine clinical trial. Don't get me wrong, that's fine with me, but to say that AIDS research has stagnated under the Bush admin is just plain wrong. As an NIH funded scientist, I should know. Money has been poured at this vaccine problem for 15 years and we're no closer now than we were in 1982.

Granted, the protease inhibitors that came out under the Clinton admin were and are miracle drugs, but those were largely the product of privately funded R&D at these eeeeevil pharma companies that folks on HuffPo love to bash.

Meanwhile, the NIH is being strangled, scientists are losing funding, etc. etc. I'd better stop before I get off on a rant.

[Qbear]

03:17 PM on 09/22/2007

", but those were largely the product of privately funded R&D at these eeeeevil pharma companies that folks on HuffPo love to bash."
BULLSH*T


Crixivan
We simply could not have created Crixivan without government R&D investments through research universities and federal policies that maintained the conditions under which we, as a private company, could take the risks of new drug development. Crixivan is already bringing hope to HIV-positive patients throughout the world, and we continue in our research to discover new and better medicines and treatments for HIV.
http://www.aau.edu/aau/Gilmartin.html

GOVERNMENT FUNDING OF NORVIR/RITONAVIR
The NIH CRISP database lists 574 federal grants to study ritonavir.

ClinicalTrials.Gov identifies 26 clinical trials planned or currently recruiting patients that involve ritonavir. Of these, 21 are sponsored by US government agencies; Abbott is the sponsor of only one; and four are sponsored by other drug companies (including two small firms).
http://www.essentialinventions.org/media/norvirgovfunding.html

I challenge you to find new AIDS treatment drugs, not in the pipeline before Bush took office. Fuzeon is one of the FEW, all the rest came under Clinton.

[DRaymond]

10:16 PM on 09/21/2007

Dang! Volunteer in an AIDS vaccine test! That's got to take some courage!

[NoahVail]

09:34 AM on 09/22/2007

Uh... I think the volunteers are already at "high risk" for getting the disease.

[factanonverba]

05:51 PM on 09/22/2007

It took no courage at all. For me, the decision was based on giving something back on doing my small part to find a vaccine. And to be fair, Merck has treated me well. There was no risk of becoming HIV positive from participating in the study. I still do not know if I received the vaccine or if I received the placebo. In return for participating in the study, I received $50 per visit, free monitoring of my general health, blood exams, and STD testing. I have no complaints and I am thankful that I participated in the Merck trials. And for the record, they will continue to monitor my health for another two years. If I was "high risk" for HIV it was from my own sexual behaivour, not from participating in the trial.

[Olerist]

09:37 PM on 09/21/2007

Health didn't matter to Merck back in 1991 when they were informed they would be overloading infants with mercury:
http://www.nomercury.org/science/documents/LATimes-Merck_Memo_2-8-05.pdf

why should ineffectiveness stop them?

I'm surprised the FDA folks looking for research money or jobs there aren't rubber stamping this and adding it to the mandatory childhood vaccine schedule

After all they approved Dr Offitt's rotavirus vaccine that damaged children in the safety testing and then later after it was released. Oh thats right Dr Offitt was on the approval boards while he held the patent.

[gvincent]

09:26 PM on 09/21/2007

Better than letting them die in a genocide perpetrated by the government...
http://www.crookedinc.com

[Kzb]

08:39 PM on 09/21/2007

It's a great idea but where in the hell would such a study with human subjects be legal?

[andyg]

10:39 PM on 09/21/2007

they knew the risk, it was their choice.

[sparkey]

08:06 PM on 09/21/2007

Merck probably knew it wouldn't work, but took the money anyway. If you knew our government wouldn't do anything about it, wouldn't you do it,too? I know I would.

[sandiegoconservative]

12:05 PM on 09/22/2007

And your evidence for this statement is?

Think about it. How much more money would Merck be worth if they found a cure? How many more grants from the government would they receive if they could prove that they have the ability to solve a complex disease like HIV/AIDS?

Don't always rush to the "stealing money" argument.

[sparkey]

04:54 PM on 09/22/2007

The republican controlled government doesn't want a cure. They consider AIDS a gay problem and not the problem of God's chosen few.