The safety and immunogenicity of a human immunodeficiency virus type 1 (HIV-1) recombinant gp160 candidate vaccine in humans
Article Abstract:
A number of laboratories throughout the world are attempting to develop a vaccine against the human immunodeficiency virus (HIV), the causative agent in AIDS. Animal models are being developed, but 'phase I data' about the safety of an HIV vaccine in humans has been limited. The National Institute of Allergy and Infectious Disease Acquired Immunodeficiency Syndrome Vaccine Clinical Trials Network (NIAID) has begun human trials of recombinant envelope glycoprotein 160 (rgp160), an HIV subunit vaccine. A total of 67 individuals who were healthy, HIV-negative, and at low risk for acquiring HIV, completed the study. The subjects were subdivided into four groups who received: a placebo; hepatitis B vaccine; rgp160 at 40 micrograms; or rgp160 at 80 micrograms. Injections were given at 0, 30, and 180 days; 52 of the 67 subjects received an injection again at day 540. The injections were generally well-tolerated; no significant immune function depression was seen in any of the subjects. Antibodies against HIV were detected by the Western blot assay in subjects who had received rgp160, often after the second dose, and quite frequently after the third. An issue of greater interest than antibody production is the ability of the vaccine to confer immunity against HIV, as measured by ability of the patients' sera to neutralize the virus or to induce complement immune activity. Neutralizing activity was seen in 5 of the 24 rgp160 patients and complement enhancement was observed in 6 of the 24 (3 of these subjects had both neutralizing activity and complement enhancement). It is concluded that the rgp160 HIV vaccine is safe and well-tolerated, but its efficacy at the doses studied is limited. Studies of higher doses of this vaccine are warranted. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: Annals of Internal Medicine
Subject: Health
ISSN: 0003-4819
Year: 1991
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Frequency of intermediate western blot tests in healthy adults at low risk for human immunodeficiency virus infection
Article Abstract:
Routine testing for human immunodeficiency virus (HIV) is becoming very popular. False-positive test results (indicating the presence of HIV in a person who does not in fact have HIV) can occur during serologic testing. Western blot tests (WB) have identified indeterminate protein bands in patients both with and without HIV infection. Previous studies have reported indeterminate WB tests in 13 to 48 percent of patients testing positive for HIV by enzyme immunoassay (EIA). The WB test was performed in 168 healthy individuals at low risk for the development of HIV. Also, blood samples were screened for HIV antibody by EIA and polymerase chain reaction assay (PCR, to detect HIV DNA). HIV was not detected in any of the subjects using the three different tests. However, 32 percent had indeterminate bands on their WB tests. None of these patients tested positive for HIV by EIA. The exact meaning of an indeterminate WB test is not known, but such a result could cause confusion when used as the sole diagnosis for the presence of HIV. It is concluded that an intermediate WB test in an individual with a negative EIA test does not indicate HIV infection. EIA and PCR should both be performed to confirm HIV diagnosis. Rescreening should be considered in individuals at low-risk for HIV who have a positive WB test. (Consumer Summary produced by Reliance Medical Information, Inc.)
Publication Name: Journal of Infectious Diseases
Subject: Health
ISSN: 0022-1899
Year: 1990
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Safety and immunogenicity of a candidate HIV-1 vaccine in healthy adults: recombinant glycoprotein (rgp) 120
Article Abstract:
Recombinant glycoprotein (rgp) 120 may be a safe and effective vaccine for the human immunodeficiency virus (HIV). Glycoprotein 120 is an especially promising vaccine antigen because it plays a role in initiating HIV infection, causes attachment to susceptible cells and is a target for neutralizing antibodies. The vaccination of 49 healthy, low-risk volunteers resulted in successful immune responses, including cytotoxic T-cell activity. The biological response modifier MTP-PE tested in some of the participants increased their immune response but also caused significant side effects.
Publication Name: Annals of Internal Medicine
Subject: Health
ISSN: 0003-4819
Year: 1996
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