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Vaccine Questions
Nov 17, 2007

Dr. Bob, I've been reading with great disappointment of the effects of the failed Merck AIDS vaccine. All of the data being brought up seems to point to the failure as being directly associated with the Adenovirus delivery vector and Associated Adenovirus Vectors.

I realize Merck was the furthest along and applaud the clinical trial process for halting the testing of a failed avenue of atack, but wonder if there is commonality of the vector being used among the other vaccines in trial. Was the failure of the Adenovirus Vector a major setback in the search for a vaccine? What does this mean for promising candidates like the GeoVax vaccine.

Thank you for all of your support and continued humor. You helped me through the roughest period of my life and have given me hope that my future hasn't been destroyed.

Response from Dr. Frascino

Hi,

Yes, this was indeed incredibly depressing news! Was this a major setback in the search for a vaccine? Unfortunately yes. What does this mean for other promising vaccine candidates? Well, several other vaccine trials have already been affected by the failure of the Merck vaccine trial. (See below). We are now looking for similarities and hopefully differences in adenoviruses versus adeno-associated viruses. Additional effort may have to be directed at other types of vaccines, such as the dendritic cell therapeutic vaccine. (The French have reported some success with this approach.)

It's also worth noting that despite the fact virtually everyone aggrees we desperately need a preventative and therapeutic HIV vaccine, only a very tiny percentage of the world's HIV research budget is dedicated to vaccine development. (Somewhere around 1%!!!) This must change if we are ever to make significant progress on an HIV vaccine. Of course if we had directed only a small portion of the funds wasted in Iraq toward HIV vaccine development most likely we'd already have both a therapeutic and preventative HIV vaccine!!! (Is it Jan 2009 yet?)

Dr. Bob

Several Vaccine Trials Affected by Halt of Merck's HIV Vaccine Trial

November 16, 2007

Several vaccine trials are being postponed or modified following the halt of Merck's experimental HIV vaccine trial, the Philadelphia Inquirer reports (Stark, Philadelphia Inquirer, 11/16). Merck in September announced that it had ended the Phase II trial, which began in late 2004 and involved HIV-negative volunteers, after the experimental vaccine failed to prevent HIV infection in participants or prove effective in delaying the progression of the virus to AIDS.

New data recently suggested that the vaccine was ineffective among some trial participants with a pre-existing immunity to a common cold virus and that the vaccine might have increased their susceptibility to HIV infection. The Merck vaccine was made from a weakened version of a common cold virus that served as a mode for providing three synthetically produced genes from HIV, known as gag, pol and nef.

After several days of discussions at an HIV Vaccine Trials Network conference last week in Seattle of Merck's trial, leaders of the trial on Monday decided to notify all of the trial's 3,000 participants whether they were given the vaccine or a placebo (Kaiser Daily HIV/AIDS Report, 11/14).

According to the Inquirer, other trials have been affected by Merck's trial because the experimental vaccines have a similar structure to Merck's vaccine. Trial participants now must be warned about the potential risks highlighted in the Merck trail if they participate in experiments that use a cold-virus carrier similar to Merck's product, Anthony Fauci, director of the National Institute of Allergy and Infectious Disease, said.

Gary Nabel, director of NIH's Vaccine Research Center, was scheduled to launch the PAVE 100 HIV vaccine trial early next year, but it recently was postponed until at least mid-2008. The PAVE vaccine uses three shots of DNA followed by a cold-virus booster shot, which has different components than the Merck vaccine. Nabel said he plans to modify the study by testing the vaccine only on people with limited exposure to colds and by increasing monitoring of patients.

Hildegund Ertl -- an immunologist at the Wistar Institute who is preparing to test an experimental HIV vaccine that uses a chimpanzee cold virus -- said the Merck trial also likely will affect her study, which is due to start in a year. "The bar will be raised," she said, adding that she hopes the chimp-based cold virus will not cause complications that the human cold virus might be causing (Philadelphia Inquirer, 11/16).

Vaccines Using Some Viruses Require Further Testing, Study Says Ertl and colleagues on Thursday in the Journal of Clinical Investigation reported that experimental HIV vaccines that typically use harmless viruses called adeno-associated viruses might damage the immune system by exhausting important cells, Reuters reports.

According to the group, AAV vaccines when tested in mice directly interfered with immune cells called CD8 T-cells, which are T-cells that a vaccine is supposed to stimulate to fight HIV. "The immune cells become exhausted," Ertl said, adding, "It is simply a defense mechanism of T-cells -- if there is too much antigen for too long a time they simply turn themselves off." The researchers said AAV vaccines should not be tested on people until more studies are conducted. Ertl said it is unclear whether her findings contributed to the developments in Merck's trial, which used an adenovirus.

Fauci said the study should be taken "with a very heavy dose of caution." He added that adenoviruses and adeno-associated viruses are very different microbes, despite the similarity of their names. "We may be dealing with apples and oranges," he said.

Pat Fast of the International AIDS Vaccine Initiative said the group has stopped testing AAV vaccines. "While we find the AAV study by Dr. Ertl and her group ... very interesting and we'll consider whether it can inform our future studies, their study was conducted in mice and there are fundamental differences between mice and humans in their respective immune responses, particularly with regard to the immune response against HIV," Fast said in a statement (Fox, Reuters, 11/15).



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