A Phase I, Multicenter, Randomized, Double-Blind, Placebo-Controlled HIV-1 Vaccine Trial to Evaluate the Safety and Immunogenicity of MN Recombinant Soluble gp120/HIV-1 (rsgp120/HIV-1) (Genentech) in Combination With QS21 Adjuvant and/or Alum in Healthy Adults

Co-existing Condition:

Subjects with the following symptoms or conditions are excluded:

Hepatitis B surface antigen.

Medical or psychiatric condition (such as recent suicidal ideation or present psychosis) that precludes compliance.

Occupational responsibilities that preclude compliance.

Active syphilis. NOTE: Subjects with serology documented to be false positive or due to a remote (\> 6 months) treated infection are eligible.

Active tuberculosis. NOTE: Subjects with a positive PPD and 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, autoimmune disease, or use of immunosuppressive medications.

History of anaphylaxis or other serious adverse reactions to vaccines.

History of allergy to thimerosal.

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 subunit or killed vaccines, such as influenza or pneumococcal, are allowed but should be given at least 2 weeks prior to HIV immunizations.)

Experimental agents within 30 days prior to study entry.

Prior HIV vaccines.

Prior Treatment:

Excluded:

Receipt of blood products or immunoglobulin within the past 6 months.

Risk Behavior:

Subjects are NOT excluded on the basis of HIV risk behaviors, but AVOIDANCE of any activity that may expose subject to HIV (e.g., unprotected sex or needle sharing) is STRONGLY RECOMMENDED.

What this study is about