Warning Sent to AIDS Merck Vaccine Volunteers

[edfu]

http://www.washingtonpost.com/wp-dyn/content/article/2007/10/24/AR2007102402514.html

This is going to blow up into a scandal of major proportions.  What ghastly, horrific news!

[edfu]

I've been told by a volunteer in this study in NYC that New York University Medical, who ran the study here, wants to unblind to warn those volunteers who actually received the vaccine that they may be "more susceptible" to HIV infection, but that Merck won't let them.

Dear God!!!!

[Smoothstone]

Thanks for the info. The controversy here underscores the importance of having community reps on advisory boards. Let us know if you hear more. Hank

[Tim Horn]

This really is distressing news.

I'm going to do my best to find out (much) more about this tomorrow.

Tim Horn

[edfu]

http://today.reuters.com/news/articleinvesting.aspx?type=bondsNews&storyID=2007-10-25T170244Z_01_N25403302_RTRIDST_0_AIDS-VACCINE-MERCK.XML

Thanks, Tim.  Your investigative work will be invaluable.  I've posted above the Reuters report, which somewhat amplifies the Washington Post's exclusive.  Not many media have picked up on this yet, if a Google News search is to be believed.  In typical fashion (and I thought they learned their lesson) the New York Times has not yet reported.  Their coverage of AIDS issues has been, as we old-timers remember, appalling, so much so that Larry Kramer and a few of us tried to initiate a boycott in 1983.  ACT UP did pick up the ball a few years later.

What really frightens me is that HIV vaccine research could be dealt a mortal blow.  It will be almost impossible to recruit new volunteers.   

[bmancanfly]

This is terrible news.

Since the vaccine itself didn't give the participants the virus, why would it make them more prone to infection.  It seems to be a very odd outcome. 

[ronaldinho]

This is terrible news.

Since the vaccine itself didn't give the participants the virus, why would it make them more prone to infection.  It seems to be a very odd outcome. 

It may have something to do with an article which i quoted on another thread:
http://forums.poz.com/index.php?topic=16249.0

Since HIV infects the very cells which are supposed to fight it, maybe the virus is not harmed, but on the contrary, benefits from the immune system producing specific cells to attack the virus, since that gives HIV the opportunity to contact and enter the defense cells.

[Smoothstone]

SOUTH AFRICA: Warning Is Sent to AIDS Vaccine Volunteers
Washington Post (10.25.07) - Thursday, October 25, 2007
Craig Timberg


--------------------------------------------------------------------------------
On Tuesday, South African researchers began telling participants in Merck & Co.'s HIV vaccine trial that the vaccine may have increased their risk of HIV infection.
Last month, researchers shut down the trial of Merck's vaccine because it was proving ineffective compared to a placebo. The South African trial of Merck's vaccine was administered separately and had its own ethics board.

South African researchers have begun "unblinding" the trial, telling the 801 mostly heterosexual volunteers in Durban, Cape Town, and Soweto whether they received the placebo or vaccine. Most are being notified by cellphone text messaging.

Merck developed the vaccine, a genetically manipulated cold virus containing HIV elements, in conjunction with the National Institutes of Health. The hope was the vaccine would stimulate the immune system, making HIV infection less likely or at least delaying the progression of infection to AIDS. While scientists say the vaccine itself could not have caused HIV infection, it could have caused immunological changes that made recipients more susceptible to infection upon later exposure to HIV.

The ethics board in the United States, which monitored all other trial sites involving 3,000 mostly gay volunteers, has not decided whether to unblind the trial, said Mark Feinberg, Merck's vice president for medical affairs and policy. Continuing research could be compromised by doing so, he said. Nonetheless, individual participants wishing to know whether they received a placebo or the vaccine will be told, he said. Researchers are counseling all participants that the vaccine could increase their HIV infection risk.

On Nov. 7, vaccine investigators are scheduled to meet in Seattle. "Given the complexity of the issue, we feel the best conclusions will be reached when all the data are analyzed in their entirety," said Feinberg.
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Comment:  We assume the ethics board is moving.  if they are willing to disclose to participants who inquire about whether they got the placebo or potentially harmful vaccine, they should inform all participants. Those less educated, less connected to internet, less connected to community, less informed would be less likely to have heard the news and less likely to inquire.

What is the counseling message?
What is the adjustment in care and support as the result of this trial outcome? short term and over time?
What options are participants given? shortterm and over time?
 
Seems there should be a substudy protocol already in place to adjust for these kind of unexpected outcomes.

The outcome and Merck's and NIH's response to it may set a precedent for standard of care/standard for response  which will motivate or repell future vaccine enrollees.

[edfu]

This is the e-mail NYU sent out to the vaccine volunteers:

"Dear xxxx,

Two weeks ago we contacted you to let you know that vaccinations in the Merck 023 vaccine study were being stopped because the vaccine was shown not to prevent HIV infection or change the course of disease. We are contacting you again because further analysis of the data shows that there were more HIV infections in male study volunteers who received at least 2 doses of the vaccine than in people who received placebo. We do not fully understand what this means.

Although still not confirmed, there is a possibility that the vaccine may have made it easier for people to get infected with HIV. Because the number of people in the study who were infected with HIV is relatively small, it is hard for statisticians (people who analyze the data) to definitively link the vaccine to increased possibility of HIV infection. This means that factors other than the vaccine may explain the difference. It could mean that the apparent increased number of HIV infections in the vaccine arm may be due to differences among study volunteers that have nothing to do with the vaccine, such as sexual practices, recreational drug and alcohol use, health differences, or chance alone.

Even though it is not confirmed that the vaccine may have increased people’s risk for becoming infected with HIV, we feel it is our obligation to inform you of this possibility.

What we do know for sure is that whether you received vaccine or placebo, you were not protected from HIV because the vaccine does not work.

We expect that, given this development, many study volunteers may wish to find out if they received vaccine or placebo (unblinding) in the study. Please let us know if you want to be unblinded right away. No matter what you received, vaccine or placebo, it is important to protect your health by using condoms. As we discussed at our study visits, condoms are the only proven way to prevent sexual transmission of HIV.

Whether you choose to be unblinded or not, we would like you to continue with this vaccine study so we can monitor your health, provide you with HIV testing, and try to learn more about the vaccine.

More study results will be made available to us in early November, and we will contact you when those results are available. The continuing analyses may not give us conclusive answers, but we will share all new information as soon as it is provided to us.

We feel very grateful to study volunteers like you who have participated in the effort to prevent HIV. We sincerely hope that the vaccine does not increase the risk of HIV infection. As we have been throughout the study, our primary concern is for your health. We will update you as more details become available. Please let us know if you would like to come into the clinic and discuss this with one of the study staff or the study doctor.

Sincerely,

xxxxxx"

[edfu]

Failure of AIDS vaccine linked to immunity to cold virus:

http://www.washingtonpost.com/wp-dyn/content/article/2007/11/07/AR2007110702466.html

Vaccine trial backfires:

http://www.abc.net.au/worldtoday/content/2007/s2085317.htm

[Esquare]

People talk about who the real heroes are all the time. I'd argue that someone that is willing to get infected with the HIV virus to help develop a vaccine for others is the real hero.

[J220]

People talk about who the real heroes are all the time. I'd argue that someone that is willing to get infected with the HIV virus to help develop a vaccine for others is the real hero.

True, but I don't think any of the volunteers were "willing" to get infected wth the virus. They were not supposed to get the virus from this vaccine or even make them susceptible- on the contrary it was supposed to be preventive.

[bear60]

bump

[Esquare]

True, but I don't think any of the volunteers were "willing" to get infected wth the virus. They were not supposed to get the virus from this vaccine or even make them susceptible- on the contrary it was supposed to be preventive.

True. Basically I want to say I am sorry they got it and that their sacrifice is highly recognized by me.

[komnaes]

A very good report from NPR on Merck

http://www.npr.org/templates/story/story.php?storyId=16161997

[edfu]

Assessing a Failed AIDS Vaccine:

http://www.time.com/time/health/article/0,8599,1681526,00.html?imw=Y

[J.R.E.]

Could a cold virus be the chief suspect in the vaccine failure?...

http://www.msnbc.msn.com/id/21674059/


Ray

[edfu]

Merck vaccine failure seriously hurts global AIDS vaccine research:

http://www.bloomberg.com/apps/news?pid=20601109&sid=aQIXYJAthREU&refer=home

[edfu]

AIDS vaccines could weaken immune system:

http://www.eurekalert.org/pub_releases/2007-11/twi-vut111107.php

[edfu]

New study just published shows why the Merck AIDS vaccine failed:

http://jem.rupress.org/cgi/content/full/jem.20512iti1