HIV Infections
Conditions
Keywords
Vaccines, Synthetic, HIV-1, HIV Envelope Protein gp160, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
Brief summary
To determine the safety and immunogenicity of 200 mcg MN rgp160 vaccine (Immuno-AG) versus placebo, administered on two immunization schedules to healthy volunteers. Per 06/15/94 amendment, to determine the safety and immunogenicity of 800 versus 200 mcg given as a fourth immunization at 9 or 11 months after the third injection (i.e., at month 17). A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a gp160 vaccine derived from the MN strain is important.
Detailed description
A gp160 vaccine developed from the IIIB strain of HIV-1 has been found to be safe and immunogenic in healthy adults. Since the MN strain of HIV-1 is representative of a larger proportion of HIV-1 isolates in the United States than is the IIIB strain, evaluation of a gp160 vaccine derived from the MN strain is important. Volunteers are randomized to receive 200 mcg MN rgp160 or placebo at months 0, 1, and 6 or at months 0, 2, and 8. For each immunization schedule, ten volunteers receive vaccine and two volunteers receive placebo. Per amendment, volunteers receive a fourth immunization of 800 or 200 mcg (or placebo) at 9 or 11 months after the third injection (i.e., at month 17) and are followed for 6 months afterward.
Interventions
BIOLOGICALgp160 Vaccine (Immuno-AG)
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Primary purpose
PREVENTION
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Subjects must have: * Normal history and physical exam. * Negative test for HIV by ELISA within 6 weeks prior to immunization. * CD4 count \>= 400 cells/mm3. * Normal urine dipstick with esterase and nitrate. * No history of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppresssive medications.
Exclusion criteria
Co-existing Condition: Subjects with the following conditions are excluded: * Positive for hepatitis B surface antigen. * Medical or psychiatric condition or occupational responsibilities that preclude compliance. * Active syphilis (NOTE: If serology is documented to be a false positive or due to a remote (\> 6 months) infection, subject is eligible). * Active tuberculosis (NOTE: Subjects with a positive PPD and normal x-ray showing no evidence of TB and who do not require INH therapy are eligible). Subjects with the following prior conditions are excluded: * History of anaphylaxis or other serious adverse reactions to vaccines. Prior Medication: Excluded: * Prior HIV vaccines. * Live attenuated vaccines within the past 60 days. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) do not exclude but should be administered at least 2 weeks prior to HIV immunizations. * Experimental agents within the past 30 days. Prior Treatment: Excluded: * Blood products or immunoglobulin within the past 6 months. Higher risk behavior for HIV infection as determined by screening questionnaire, including: * History of injection drug use within 12 months prior to study entry. * Higher or intermediate risk sexual behavior.
Countries
United States
Outcome results
None listed