Research Initiative Treatment Action (RITA!); Vol 5, No. 1 January 1999
Stephen Tyring, MD, PhD
The University of Texas Medical Branch (UTMB) is the first and only site in Texas to test a new vaccine to prevent acquisition of the human immunodeficiency virus (HIV), the virus that causes AIDS. With thousands of people acquiring HIV every day, the need for such a vaccine is great. The old saying, "an ounce of prevention is worth a pound of cure" is especially true for viral vaccines since we presently have no cure for viral diseases such as AIDS. Indeed, we do have very effective drugs for the treatment of HIV infections, and these drugs do prolong life and improve the quality of life. These drugs, however, have many limitations such as their high cost (up to $20,000 per year) and the development of resistant strains of the virus. Most recently, AIDS patients who appeared to be responding well to these drugs, were found to still have HIV in their semen. Therefore, the virus could still be transmitted sexually even from AIDS patients taking otherwise effective therapy.
Viral vaccines have proven to be effective. The 15 viral vaccines approved by the U.S. Food and Drug Administration (FDA) have saved millions of lives and billions of dollars. The fact is especially true of the smallpox vaccine that led to the eradication of this deadly disease little more than twenty years ago. The same is projected to become true for polio in a few more years. Therefore, vaccines have been the most effective way of dealing with viral diseases.
Vaccines, however, are not the only way of preventing HIV infection. Other means include testing blood products, not sharing needles and safe sex. The only "safe sex" guaranteed to prevent transmission of HIV is abstinence. Other methods such as condoms can only reduce the chances of transmitting HIV, not eliminate it. This fact is well documented by the marked increase in prevalence of HIV and other sexually transmitted diseases during the past two decades while physicians and other health care workers have promoted "safe sex." Thus, if persons at risk for these diseases have been practicing safe sex, it hasn't been safe enough.
It is not yet known whether the AIDS vaccine being tested at UTMB will protect a person from acquiring HIV; that is the reason that persons at high risk for acquiring HIV are needed to volunteer for the study. The investigators are especially interested in partners of AIDS patients, gay and bisexual men as well as women who meet certain high-risk criteria.
It is certain, however, that the vaccine cannot give a person AIDS. This fact is true since no part of the vaccine was ever part of the AIDS virus. The vaccine, rather, is produced by genetic engineering and is thus copies of proteins found on the surface of the AIDS virus (i.e. gpl20). In fact the vaccine is bivalent, meaning that it actually contains two proteins, to protect against different strains of the AIDS virus that attack two different cell types in the human immune system. This vaccine has already been proven to be safe in a variety of laboratory animals. In fact, chimpanzees given this vaccine were protected from infection with HIV after receiving intravenous injection with this virus. This vaccine and a similar formulation have been given to over l200 human volunteers. No serious vaccine related side effects have been noted. Although safety will continue to be monitored in the present study, the principal remaining question is "Does the vaccine help to prevent HIV infection in people who are at high risk for acquiring HIV through sexual activity?" In order to answer this question, 5,000 volunteers are being enrolled in this study in the United States, Canada and Europe. Another 2,500 persons will participate in Thailand.
The vaccine will not be a substitute for safe sex but may serve to supplement such practices. To encourage volunteers to practice safe sex during the study, they will be required to participate in standardized risk reduction counseling throughout the study.
If you feel you are at high risk of acquiring HIV, call to see if you qualify for the study. Inquiries, HIV testing and all procedures are strictly confidential and free to qualified individuals. In addition, you will be compensated for your travel. For further information, call The UTMB Center for Clinical Studies at 281-333.2288 (Houston) or UTMB (Galveston) at 409-772.1641.
More than 40 experimental HIV vaccines have been tested in humans worldwide. Vaccine approaches in development or in clinical trials include the following:
From "Clinical Research on HIV/AIDS Vaccines" National Institutes of Allergy and Infectious Diseases, May 1997
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Copyright © 1999 - Research Initiative Treatment Action (RITA!). Reproduced with permission. RITA! is published by The Center for AIDS. Contact Thomas Gegeny, MS, ELS, Editor, RITA! for permission to reproduce RITA!. tom@centerforaids.org. http://www.centerforaids.org
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