Redfield, Robert R., Birx, Deborah L., Ketter, Nzeera, Tramont, Edmund, Polonis, Victoria, Davis, Charles, Brundage, John F., Smith, Gale, Johnson, Steven, Fowler, Arnold, Wierzba, Thomas, Shafferman, Avigdor, Volvovitz, Franklin, Oster, Charles, and Burke, Donald S.
The most effective weapon against viral diseases is immunization. It is not yet known, however, whether immunization will ultimately prove to be effective in the battle against AIDS. It is well established that patients infected with the AIDS virus (human immunodeficiency virus, HIV) develop antibodies against the virus, but these antibodies cannot prevent the ultimate progression of the disease. However, it may be possible to slow the progression of AIDS by assisting, with immunization, the production of antibodies in patients already infected with HIV. This possibility was evaluated in 30 subjects in the early stages of HIV infection. The patients were inoculated not with the AIDS virus, but with gp160. This protein is a part of the outer envelope of HIV; gp160 for inoculation purposes was prepared by cloning the gp160 gene and growing large quantities in the laboratory. The 30 subjects were divided into six groups; each group was vaccinated according to one of two schedules and at one of three different doses of vaccine. Measurements of the antibody response to gp160 showed that 19 of the 30 patients developed increased levels of antibodies in response to the immunization. A critical factor determining the response of the patient appears to be the stage of the disease. HIV-infected patients suffer a progressive loss of T cells with the CD4 antigen from their blood, and this loss serves as a useful measure of the progression of the infection. In the present study, 13 of the 16 subjects who still had more than 600 CD4 cells per milliliter of blood developed a successful antibody response, in contrast with 6 of the 14 subjects who had fewer than 600 CD4 cells per milliliter. It is too early to tell if the patients with a successful response to the gp160 vaccine will have a slower progression of disease. However, after 10 months the CD4 cell count has not decreased in the 19 patients who responded to immunization, while an average 7.3 percent decrease in the CD4 count was observed in the 11 subjects who did not respond. The results of this study indicate that the gp160 vaccine is safe and capable of eliciting an immune response in some HIV-infected patients. Furthermore, there is reason to suspect that the disease progression may be slower in the patients who responded successfully to immunization. (Consumer Summary produced by Reliance Medical Information, Inc.)