HIV Infections
Conditions
Keywords
Vaccines, Synthetic, HIV-1, Adjuvants, Immunologic, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity, HIV Preventive Vaccine
Brief summary
To determine the safety and immunogenicity of rgp120/HIV-1SF2 combined with MF59 adjuvant emulsion versus MF59 alone in HIV-negative volunteers. One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant.
Detailed description
One approach to improve the immunogenicity of an HIV-1 subunit protein vaccine is to combine the immunogen with an adjuvant. Healthy volunteers receive intramuscular injections of rgp120/HIV-1SF2 with MF59 adjuvant emulsion or MF59 alone at months 0, 1, 6, 9, 10 and 12 (was months 0, 1, 6 and 10, amended 12/19/96).
Interventions
BIOLOGICALMF59
BIOLOGICALrgp120/HIV-1 SF-2
Sponsors
National Institute of Allergy and Infectious Diseases (NIAID)
Study design
Primary purpose
PREVENTION
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
Inclusion criteria
Volunteers must have: * Normal history and physical exam. * HIV negativity. * Absolute CD4 count \>= 400 cells/mm3. * Normal urine dipstick with esterase and nitrite. * Lower risk sexual behavior.
Exclusion criteria
Co-existing Condition: Subjects with the following symptoms or conditions are excluded: * Positive hepatitis B surface antigen. * Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance. * Active syphilis. NOTE: Subjects with serology documented to be a false positive or due to a remote (\> 6 months) treated infection are eligible. * Active tuberculosis. NOTE: Subjects with a positive PPD and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible. Subjects with the following prior conditions are excluded: * History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications. * History of anaphylaxis or other serious adverse reactions to vaccines. * History of serious allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension). * Prior psychiatric condition (such as history of suicide attempts or past psychosis) that precludes compliance. * History of cancer unless there has been surgical excision that is considered to have achieved cure. Prior Medication: Excluded: * Live attenuated vaccines within 60 days prior to study entry. NOTE: Medically indicated killed or subunit vaccines (e.g., influenza, pneumococcal) do not exclude if administered at least 2 weeks from HIV immunizations. * Experimental agents within 30 days prior to study entry. * Prior HIV vaccines. Prior Treatment: Excluded: * Blood products or immunoglobulin within the past 6 months. Identifiable high-risk behavior for HIV infection, including: * History of injection drug use within past 12 months. * Higher risk sexual behavior.
Countries
United States
Outcome results
None listed