Philadelphia Inquirer Examines Merck's Failed International HIV Vaccine Trial
International HIV Vaccine Trial
Merck's decisionlast month to halt its international HIV vaccine trial was not a"definitive blow" to HIV vaccine research and development, but itcreated questions about whether research was "careening down the wrongpath," the Philadelphia Inquirer reports (Stark, Philadelphia Inquirer,10/7). Merck announced that it had ended its Phase II trial, whichbegan in late 2004 and involved 3,000 HIV-negative volunteers, afterits experimental vaccine failed to prevent HIV infection inparticipants or prove effective in delaying the progression of thevirus to AIDS. The trial was stopped by the Data and Safety MonitoringBoard, an independent overseer.
Some researchers havetheorized that because HIV-positive people who have stronger T-cellresponses tend to fight the virus better, a vaccine that simulated aT-cell response might be able to control HIV/AIDS. The Merck vaccinewas made from a weakened version of a common cold virus that served asa mode for providing three synthetically produced genes from HIV, knownas gag, pol and nef (Kaiser Daily HIV/AIDS Report,9/24). According to Mark Feinberg, Merck's vice president for MedicalAffairs for Vaccines and Infectious Diseases, an estimated 90% ofvaccine studies were using major elements of Merck's experimentalvaccine.
Some researchers said the trial might prove usefulfor researchers. "The information is going to help us develop a vaccinein the future," Ian Frank -- director of the HIV Vaccine Trials Unit atthe University of Pennsylvania,which enrolled 125 people in Merck's trial -- said, adding, "I don'tthink people should be overly disappointed. We're really at the veryearliest stages in this process." Gary Nabel, director of NIH's Vaccine Research Center,said, "To paraphrase some of my colleagues, the trial shows a failureof a specific product but not a failure of a concept," adding that itwould be "truly remarkable" to see an effective vaccine developed inthe next 10 years.
John Shiver, head of Merck's basic researchin vaccines, said he believes that no current approaches toward HIVvaccine development are working and that a new approach is needed. Theworld is spending $759 million annually on HIV vaccine development, upfrom $150 million annually in the 1990s, Seth Berkley, president of theInternational AIDS Vaccine Initiative, said. More than 90% of the funding is coming from governments, the Inquirer reports (Philadelphia Inquirer, 10/7).
The halt of Merck's HIV vaccine trial is "not the death of the quest; it's an opportunity to bend more strength to it," an Inquirer editorial says. Because of previous research that did not yield an effective HIVvaccine, we know much more about how the "fiendishly well-armedretrovirus associated with AIDS operates," according to the editorial.The Inquirer adds "our failures guide us to oursuccesses" and "failures should spur funders not only to keep backingresearch and development, but also to step it up." This "quest willneed friends in society and government," that is, "if we really care,"the editorial concludes (Philadelphia Inquirer, 10/6).
Reprinted with permission from kaisernetwork.org. You can view theentire Kaiser DailyHIV/AIDS Report, search the archives, and sign up for email delivery at kaisernetwork.org/email . TheKaiser Daily HIV/AIDS Report is published for kaisernetwork.org, a free service ofThe Henry J. Kaiser Family Foundation.