NIH advisers endorse disputed vaccine trial.
Top advisers to NIH "Not invented here." See digispeak.
NIH - The United States National Institutes of Health. Director Bernadine P. Healy voted last week to back a controversial congressional order to begin the first large-scale clinical trial of therapeutic vaccines designed to boost the immune systems of people infected with HIV HIV (Human Immunodeficiency Virus), either of two closely related retroviruses that invade T-helper lymphocytes and are responsible for AIDS. There are two types of HIV: HIV-1 and HIV-2. HIV-1 is responsible for the vast majority of AIDS in the United States. the AIDS-causing virus.
The advisory committee endorsed the recommendations of a scientific panel that last month favored a modified form of the mandated vaccine trial A vaccine trial is a clinical trial that aims at establishing the safety and efficacy of a vaccine prior to it being licensed. Methodology
A basic trial might involve forming two groups from a random sample of the target population. -- based on preliminary medical evidence, the urgency of the AIDS epidemic, and the promise of $20 million in government funds. Such a trial could require 30,000 people if completed in two years; 14,000 if the trial lasted five years, according to according to
1. As stated or indicated by; on the authority of: according to historians.
2. In keeping with: according to instructions.
3. NIH statistician Susan S. Ellenberg.
The results of many small, independent clinical studies suggest that therapeutic vaccines containing proteins called gp120 and gp160, cloned from HIV's outer shell, might slow or stop the progress of HIV in people already infected with the virus. In contrast, preventive AIDS vaccines are designed to bolster the immune defenses of uninfected people before exposure to HIV.
In October, Congress drew strong criticism from federal researchers and health officials when it set aside $20 million of the 1993 Department of Defense (DOD (1) (Dial On Demand) A feature that allows a device to automatically dial a telephone number. For example, an ISDN router with dial on demand will automatically dial up the ISP when it senses IP traffic destined for the Internet. ) appropriation specifically for a clinical trial of a gp160-based vaccine developed by MicroGeneSys, Inc., of Meriden, Conn.
Anthony S. Fauci, director of the National Institute of Allergy and Infectious Diseases infectious diseases: see communicable diseases. , told Science News that members of the panel were particularly displeased dis·please
v. dis·pleased, dis·pleas·ing, dis·pleas·es
To cause annoyance or vexation to.
To cause annoyance or displeasure. that Congress had singled out the MicroGeneSys vaccine after extensive lobbying by the company and its lobbyist, former Senator Russell B. Long Russell Billiu Long (November 3, 1918 – May 9, 2003) was an American politician who served in the United States Senate as a Democrat from Louisiana from 1948 until 1987. .
Healy has criticized the appropriation repeatedly, calling it an attempt to dodge the peer review process, whereby qualified experts and researchers would evaluate the vaccine's scientific merits. Healy condemned the spending measure again at the advisory committee meeting last week, describing it as a "dangerous and possibly deplorable precedent for biomedical research."
Congress, however, did not exclude federal researchers completely from the decision process. The spending measure included a proviso that the trial could be stopped by the combined disapproval of NIH, the Food and Drug Administration (FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. ), and DOD. In that case, the money would go to other AIDS research programs conducted by the military.
The bill also called on NIH to weigh the scientific merits of gp160 and advise on how a large-scale trial of the drug might proceed. This gave Healy an opportunity to convene a blue-ribbon panel, which met on Nov. 5 and Nov. 23. Its members included Fauci, FDA Commissioner David Kessler, representatives of DOD, and AIDS research advocates.
The panel concluded that currently available data on gp160, showing the vaccine is nontoxic and seems to provoke some immune response immune response
An integrated bodily response to an antigen, especially one mediated by lymphocytes and involving recognition of antigens by specific antibodies or previously sensitized lymphocytes. in those treated, would not ordinarily justify a large, expensive clinical trial. But in this case, because of the severity of the AIDS epidemic and the promising but inconclusive evidence that gp160 strengthens the body's defenses against HIV, the panel decided that the DOD appropriation should be spent on such a trial.
Panel members stipulated, however, that the trial should involve more than just the MicroGeneSys product. Other possible candidates include the gp120-based vaccines developed by Genentech, Inc., of South San Francisco South San Francisco, city (1990 pop. 54,312), San Mateo co., W Calif.; inc. 1908. South San Francisco has several industrial parks; its manufactures include medical supplies and equipment, foods, paint, paper products, consumer goods, and clothing. , Calif., and the Biocine, Co., of Emeryville, Calif., and a gp160-derived vaccine from Immuno AG of Vienna, Austria.
Both Kessler and Fauci ref used to speculate in interviews with Science News about the criteria researchers would use to choose vaccines for the trial.
Participants in the DOD-funded trial should not be limited to military personnel but should include a diverse sample of the population, including minority groups, intravenous-drug users, and others whose incidence of HIV infection is high, the panel noted.
Besides backing Healy's blue-ribbon panel, the advisory committee recommended that another expert panel meet to draw up a proposed experimental design for the vaccine trial. This protocol would include the criteria for choosing candidate vaccines.