To evaluate the safety and immunogenicity of a combination of microparticulate monovalent
HIV-1 MN synthetic branched peptide candidate vaccine for oral administration and monovalent
HIV-1 MN synthetic branched peptide vaccine in alum for intramuscular administration in
intermediate or higher risk HIV-negative volunteers.
Volunteers receive one of two schedules of vaccines or placebo administered at days 0, 28,
and 168. Specifically, group 1 receives oral microparticulate monovalent vaccine over 3
consecutive days on days 0, 1, and 2, and 28, 29, and 30, with the intramuscular monovalent
vaccine given on day 168. Group 2 receives the intramuscular vaccine first, on day 0,
followed by the oral form given on days 28, 29, and 30 and 168, 169, and 170. Volunteers are
followed for 1 year.
Volunteers must have:
- Normal history and physical exam.
- HIV negativity.
- CD4 count >= 400 cells/mm3.
- Intermediate or high risk sexual behavior or a history of injection drug use within
12 months prior to study entry.
- Normal urine dipstick with esterase and nitrite.
Volunteers with the following symptoms or conditions are excluded:
- Active tuberculosis.
- Occupational or other responsibilities that would prevent completion of study.
Volunteers with the following prior conditions are excluded:
- History of immunodeficiency, chronic illness, autoimmune disease, or use of
- Psychiatric, medical, or substance abuse problems within the past 6 months that would
affect ability to participate in study.
- History of anaphylaxis or other serious adverse reactions to vaccines.
- History of inflammatory gastrointestinal disease, celiac disease, or intestinal
- Acute gastroenteritis or gastrointestinal surgery within the past 12 months.
- Live or attenuated vaccine within the past 60 days.
- Illicit or experimental agents within the past 30 days. Intermediate or high risk
sexual behavior. Injection drug use within the past 12 months.