A Phase I Safety and Immunogenicity Trial of HIV-1 gp120 C4-V3 Hybrid Polyvalent Peptide Immunogen Mixed in Mineral Oil Containing Mannose Mono-Oleate (IFA)

Inclusion Criteria

Volunteers must have:

• Negative ELISA for HIV within 8 weeks of immunization.
• Normal history and physical examination.
• Normal chest x-ray within 4 weeks prior to initial immunization.
• Low-risk sexual behavior as defined by AVEG.

Exclusion Criteria

Co-existing Condition:

Volunteers with the following conditions are excluded:

• Medical or psychiatric condition that precludes compliance with the protocol, including recent suicidal ideation or present psychosis.
• Occupational responsibilities which preclude compliance with the protocol.
• Active syphilis (if the serology is documented to be a false positive or due to a remote [more than 6 months] treated infection, the volunteer is eligible).
• Active tuberculosis (volunteers with a positive purified protein derivative and a normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy are eligible).
• Positivity for hepatitis B surface antigen.

Volunteers with the following prior conditions are excluded:

• History of immunodeficiency, chronic illness, malignancy, or autoimmune disease. NOTE: Individuals with a history of cancer are excluded unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
• History of suicide attempts or past psychosis.
• 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).
• History of lung disease.

Prior Medication:

Excluded:

• Live attenuated vaccines within 60 days of study. NOTE: Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) are not exclusionary, but should be given at least 2 weeks away from HIV immunizations.
• Experimental agents within 30 days prior to study.
• HIV-1 vaccines or placebo, received in a previous HIV vaccine trial.
• Immunosuppressive medications.

Prior Treatment:

Excluded:

• Receipt of blood products or immunoglobulin in the past 6 months.

Risk Behavior: Excluded:

• Alcohol intake greater than or equal to the equivalent of 1 oz of 100 proof per day (4 oz. glass of wine or 12 oz. of beer per day).
• Identifiable higher-risk behavior for HIV infection as determined by screening questions designed to identify risk factors for HIV infection; specific exclusions include a history of injection drug use within the last 12 months prior to enrollment and higher- or immediate-risk sexual behavior as defined by the AVEG (i.e., meeting the criteria for AVEG Risk Groups C and D).

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety