A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers
A Randomized, Placebo-Controlled, Double-Blinded Phase I Safety and Immunogenicity Trial of Recombinant Envelope Protein, HIV-1 SF-2 rgp120 (BIOCINE), Combined With MF59 in HIV-1 Uninfected Adult Volunteers
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.
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).
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.