Important note: Information in this article was accurate in 1997. The state of the art may have changed since the publication date.
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The San Francisco Examiner - Wednesday, May 21, 1997
Lisa M. Krieger of the Examiner Staff
Thirty high-risk gay men in San Francisco have been recruited for the trial; they will be part of a nationwide network of 420 volunteers in 13 cities.
Inoculations are expected to start in late June - then to be repeated one, three and six months later, in hopes of kicking the immune system into gear.
"We're proud to be part of the national effort to find new ways to stop the spread of the AIDS epidemic," said Dr. Susan Buchbinder of the Department of Health's AIDS Office Research Branch and one of four co-chairs of the national trial, funded by the National Institute of Allergy and Infectious Diseases.
The men's blood will be tested for HIV infection and changes in immune response at three-month intervals for two years.
If proven to safely stimulate the immune system, the vaccine will move into a trial of 3,500 volunteers in the United States in 1998 - a trial designed to answer the question of whether it actually protects against HIV infection.
Preliminary results, presented at the Fourth Conference on Retroviruses and Opportunistic Infections last January, suggest that the two-in-one product is safe and able to elicit two important types of immune response in human volunteers.
It uses a combination approach - a live "canarypox" virus derived from birds that is genetically engineered to carry genes of the AIDS virus. It is supplemented by injections of genetically engineered protein to create a broader and, it is hoped, more protective response than seen in previous vaccines. It cannot cause AIDS.
The combination vaccine is provided by the manufacturers, Pasteur-Merieux-Connaught of Lyon, France, and Chiron Vaccines of Emeryville.
Only one other vaccine, developed by Dr. Don Francis of Genenvax in South San Francisco, has gotten this far in testing. The Genenvax vaccine uses a genetically engineered copy of an HIV surface protein, similar to the second half of the vaccine in the upcoming San Francisco trial. But it failed to win approval for expanded testing by the National Institutes of Health and is undergoing scientific refinement.
A different but also promising approach is being attempted by researchers at Harvard's New England Regional Primate Center in Southboro, Mass. In a highly publicized finding earlier this year, they gave macaque monkeys a giant injection of SIV, the monkey version of HIV - but the animals stayed uninfected. What saved the monkeys was built out of a genetically weakened version of SIV. This crippled virus somehow primed their immune system to ward off the real thing.
The goal of all AIDS vaccines is to trigger an immune-system alarm, so the body is prepared to fend off HIV infection, if exposed.
Will they prevent HIV infection? It is not known.
A problem, says Joe Wright, community health educator with the city Health Department, is that it is not known exactly what kind of immune response will provide protection. Nor is it known how strong this response must be to ward off infection.
Early candidate vaccines were able to target free-floating virus in the blood. But they seemed powerless against the virus that hides within cells.
Later vaccines went after the hidden virus by killing infected cells. But they did nothing to stop free-floating virus.
The two-in-one vaccine is designed to go after both free-floating and hidden virus by stimulating different parts of the immune system. Researchers are not yet certain that both responses are needed, but the approach makes sense, they say.
Treatment news
*Crixivan, the protease inhibitor made by Merck & Co. Inc., is available at local pharmacies nationwide. Until recently, the limited supplies of the drug required that its distribution be limited to Stadtlanders Pharmacy, a national mail-order outlet.
*ACT UP / Golden Gate has sponsored a Web site for people having poor or unusual responses to the new anti-HIV drug combinations. Called the "Protease Inhibitor Response Project," the Web site (http: / / www.netcom.com / protease) collects patients' medical histories to improve understanding of the problem of treatment failures. Call (415) 252-9200 or e-mail Steve LeBlanc at actup@actupgg.org.
*A combination of protease inhibitors and other anti-HIV drugs used to treat people with HIV can prevent or delay the progression of cytomegalovirus (CMV) retinitis, a potentially blinding eye infection, according to the latest issue of the Journal of the American Medical Association. Researchers at the National Institutes of Health found that some CMV retinitis patients were able to stop the standard CMV treatment, which can cause kidney damage and low blood cell counts, without worsening the eye disease.
*Doctors at St. Vincent's Hospital and Medical Center in New York report in the New England Journal of Medicine that from 1994 to 1996 the average inpatient census of HIV patients dropped by 28 percent. From 1995 to 1996, it dropped by 24 percent. The average length of stay was reduced to 12.6 days from 15, a 16 percent decrease. There was a corresponding increase in outpatient visits. Doctors credit the introduction of combination therapies with the declining need for hospitalization.
But use of the treatments resulted in a marked increase in spending on drugs: from $28,471 in 1995 to $219,446, an eight-fold increase.
The toll
Ricky Snelling, 36, an Ohio native and cable technician at Viacom-TCI Cable who loved playing the piano and baking cakes and pies ... Matthew Paul Shankle, 35, who worked at Crown Books and P.O. Plus and loved gardening, needlepoint, pottery, country music and traveling with his partner, Jeff McLaughlin.
Date
reported / Cases / Deaths
S.F. 4/1 23,974 16,692
Calif. 4/1 99,908 64,137
U.S. 4/1 548,102 343,000
WHO(rprtd) 4/1 8,400,000 6,400,000
Figures are cumulative since June 1981.
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