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Merck halts study of "ineffective" HIV vaccine

NEW YORK (Reuters) - Merck & Co has halted testing of its experimental HIV vaccine, long considered one of the most promising vaccines in development, after a monitoring board found it was ineffective, the company said on Friday.

The failed tests represent a major setback in the global effort to stem infections with the virus that causes AIDS. Merck had expressed great optimism for the vaccine, which it has been testing for a decade.

The independent Data Safety Monitoring Board, after reviewing interim results of the study of the vaccine, recommended discontinuing vaccinations of volunteers as the trial was headed for failure, Merck said.

“No one really knows when and if we will ever have an effective HIV vaccine because the virus is such a great challenge,” Mark Feinberg, vice president of medical affairs at Merck’s vaccine unit, said in an interview.

The vaccine consisted of a common cold virus loaded with three proteins found in the HIV virus.

“The concept was that if someone getting the vaccine is later exposed to HIV, the immune system would recognize those HIV proteins and go after the virus,” said Keith Gottesdiener, another senior Merck research executive.

Asked if Merck would attempt to develop other HIV vaccines in the wake of the failed trial, Gottesdiener said, “At this point, we can’t give an answer; we’re just starting to look at this data and all its implications.”

The New Jersey-based company, which was developing the product in partnership with the federally funded HIV Vaccine Trials Network, said two other early-stage trials of the vaccine had also been discontinued.

Study investigators have been instructed to discontinue vaccinating volunteers and to monitor them, Merck said.

The study was aiming to determine whether the vaccine prevented HIV infection and whether it reduced the amount of virus in those who developed infection.

Although a number of medicines have been introduced in recent years that control the virus and keep symptoms of the otherwise fatal disease at bay, doctors have said a preventive vaccine is by far the best way to control continued spread of the disease.

The HIV Vaccine Trials Network, the largest clinical trials program for developing and testing HIV vaccines, helps coordinate vaccine efforts around the world.

“Today is a very sad day for the industry because Merck’s vaccine had shown an ability to turn on the immune system, which gave many people optimism it would work,” said Sarah Alexander, a spokeswoman for the trials network.

Although more than two dozen other HIV vaccines are now being tested for safety in human trials, only one is far enough along in trials to be tested for actual effectiveness, said Mitchell Warren, executive director of the AIDS Vaccine Advocacy Coalition.

“The Merck vaccine was a step along the way that will give us clues how we can better trigger the immune system with other vaccines,” Warren said.

An HIV vaccine formerly deemed to hold promise, developed by U.S. biotech company VaxGen Inc, was declared a failure in late 2003.

Millions of people have succumbed to AIDS since it started becoming prevalent in the early 1980s, with the worst outbreaks in Africa. The virus is now believed to be spreading quickly in India, China and other parts of Asia, fueled by unprotected sexual contact, prostitution and shared needles among drug users.

As many as 1 million Americans are believed infected with the virus. Many have insurance that covers the costly drug cocktails needed to prevent uncontrolled growth of the virus. But the drugs, which can cause serious side effects, must be taken for life because they cannot totally eradicate the quickly mutating virus.

Merck’s discontinued international trial, called STEP, involved 3,000 HIV-negative volunteers from diverse backgrounds, between the ages of 18 and 45, at high risk of HIV infection.

An interim efficacy analysis, conducted in about 1,500 volunteers expected to have the best response to the vaccine, showed the drug was ineffective.

Although the vaccine has been a major hope among the medical community, it was not deemed to have major commercial potential, and Merck shares were little affected by the news. The shares closed up 44 cents to $51.82 on the New York Stock Exchange.

Additional reporting by Bill Berkrot

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