To evaluate the safety and tolerability of the Chiron vaccine human immunodeficiency virus
(HIV) p24(25 or 50 micrograms)/MF59 in healthy HIV-1 seronegative adults. To evaluate the
immunogenicity of the HIV p24(50 micrograms)/MF59 vaccine.
This study evaluates the safety and immunogenicity of the Chiron vaccine HIV p24/MF59. In
Part A, 15 volunteers are randomly assigned to receive either HIV p24/MF59 or a placebo at
0, 1, and 6 months. 10 volunteers receive the vaccine and 5 volunteers receive the placebo.
If no serious adverse events are observed within 1 week after the first injection in these
first 15 patients, Part B is initiated. In Part B, 25 volunteers are randomly assigned to
receive HIV p24/MF59 or a placebo at 0, 1, and 6 months. 20 volunteers receive the vaccine
and 5 volunteers receive the placebo.
Volunteers must have:
- Good health as determined by medical history, physical examination, and clinical
- Negative serology for HIV infection as determined by licensed HIV ELISA test
performed within 6 weeks prior to first immunization.
- In vitro Epstein-Barr virus-immortalized cell line from peripheral blood can be
established (required for selected Part B volunteers only).
Volunteers with the following symptoms or conditions are excluded:
- Significant acute systemic infection.
- Occupational or other responsibilities that would prevent completion of participation
in the study.
- Any condition that might interfere with the evaluation of the study objectives.
Volunteers with the following prior conditions are excluded:
- History of immunodeficiency, autoimmune disease, or any serious chronic illness.
- Evidence of psychiatric or medical history or substance abuse that would adversely
affect the volunteer's ability to participate in the trial.
- History of anaphylaxis or other serious adverse reactions to vaccines or vaccine
1. Immunosuppressive medications.
- Live, attenuated vaccine within 60 days of study entry.
- Medically indicated subunit or killed vaccines (e.g., influenza or pneumococcal) are
not exclusionary but should be given at least 4 weeks before or after HIV
immunizations to avoid potential confusion of adverse reactions.
- Experimental agents within 30 days of study entry.
- HIV vaccine or MF59 adjuvant. Blood products or immunoglobulins in the past 3 months.
Engaging in high-risk behavior within 6 months of study entry, i.e.:
- injection drug use, sexual intercourse without a condom with 4 or more partners or
with known iv drug user or HIV+ partner, or newly acquired sexually-transmitted