Gay Men's Health Crisis: Treatment Issues, Volume 7 no. 5 - May, 1993

After nearly a year of turmoil, the Department of Defense (DOD) agreed to transfer a controversial $20 million Congressional appropriation for HIV vaccine therapy research to the Department of Health & Human Services (HHS). The Congressional set-aside was initially made to the DOD to study only one vaccine product, Vaxsyn, MicroGeneSys's gp160 product. However, critics argued that VaxSyn was no more worthy of targeted funding than other vaccine products, including those manufactured by Genentech, Immuno AG, Immune Response Corp., and Chiron. Also, critics charged that scientists, not Congress, should set scientific priorities.

In January 1993, a blue-ribbon panel of leading scientists and patient advocates appointed by Dr. Bernadine Healy, Director of the National Institutes of Health (NIH) recommended that the funds be used to evaluate the clinical usefulness of several vaccine products. The trial could include 6,000 to 12,000 participants. While no protocol has yet been released, it is expected that the final study will comply with these recommendations.

The DOD, heavily lobbied by MicroGeneSys's President, Frank Volvowitz, initially opposed the comparative study, and announced that it would test only VaxSyn against placebo. However, the DOD finally accepted the NIH position. A statement released by the DOD says "Transfer of the funds will permit rapid initiation of studies through NIH's large, established AIDS Clinical Trials Group (ACTG) network of civilian medical research units throughout the United States."

As Treatment Issues goes to press, a new complication has emerged. Rumors abound that MicroGeneSys has refused to provide Vaxsyn to the NIH for the comparative study. Volvowitz refused to comment to Treatment Issues on the rumors. By threatening to charge the NIH to study Vaxsyn, MicroGeneSys may hope to scuttle the comparative study. The $20 million allocation is insufficient to fund the large, comparative trial if the cost of drug is included.

Vaccine Vocabulary

Adjuvant: a substance, usually mineral oils and/or killed mycobacteria, added to a vaccine preparation to increase the immune response to it.

Antibody Dependent Cellular Cytotoxicity: direct killing of an infected cell by lymphocytes when it is coated with antibodies.

Binding Antibodies: proteins produced by B cells which bind antigens and form immune complexes.

Chimpanzees: an endangered ape native to Africa used in HIV research. Extremely limited supplies, and their high cost, limit their use in research. Chimps are the only other mammal, besides humans, that can be infected by HIV.

Dendritic cells: Immune cells with long, tentacle like branches called dendrites. Four types of dendritic cells are recognized: follicular dendritic cells, lymphoid dendritic cells, interdigitating cells, and Langerhans' cells. Their exact function is still unknown, although it appears to be antigen presentation to lymphocytes. Follicular dendritic cells: a dendritic cell found in lymphoid follicles. (see dendritic cells)

Langerhans cells: a dendritic cell found in the skin. (see dendritic cells)

Live-attenuated vaccine: a vaccine composed of a live virus chemically or procedurally weakened so that it is incapable of causing disease.

Macaques: any monkey of the genus Macacca, including rhesus monkeys.

Natural Killer Cells (also called NK cells): Immune cells which kill infected cells directly within four hours of contact. NK cells differ from other killer cells, such as cytotoxic T lymphocytes, in that they do not require contact with antigen before they are activated.

Neutralizing Antibodies: proteins produced by B cells which can directly inactivate an invading microorganism, such as a virus or bacterium.

Nef-deleted vaccine: a live-attenuated HIV vaccine composed of HIV with nef, a key component of the virus, deleted to lessen its ability to replicate or reproduce.

Post-infection immunization: see therapeutic vaccines

Prophylactic vaccine (also called preventive vaccine): a vaccine administered prior to infection with a disease causing microorganism to create an immune response which prevents infection.

Proteins: substances which form the major component of cells, involved in all essential life functions.

Rhesus monkeys: (Macacca mulatta). A small monkey native to India used frequently for research purposes, especially testing the safety and efficacy of vaccines.

Subunit vaccine: a vaccine composed solely of a synthetically produced piece of the virus, usually by recombinant DNA technology.

Therapeutic vaccine: a vaccine administered after infection with a disease causing microorganism to modify the immune response to cure or improve the course of disease.

Vaccine: A substance, usually derived from a microorganism, which can induce immunity to disease.

Whole-killed virus vaccine: a vaccine composed of an intact, but killed, virus.

Copyright (c) 1993 - GMHC Treatment Issues. Noncommercial reproduction encouraged. Distributed by AEGIS, your online gateway to a world of people, knowledge, and resources. http://www.aegis.com

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