A Phase I/II Safety and Immunogenicity Trial of UBI Microparticulate Monovalent (HIV-1 MN) Branched Peptide Vaccine in HIV-1 Seronegative Human Subjects

Launched by UNITED BIOMEDICAL · Aug 30, 2001

Keywords

ClinConnect Summary

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.

Gender

ALL

Eligibility criteria

• • Inclusion Criteria
• 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.
• • Exclusion Criteria
• Co-existing Condition:
• 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 immunosuppressive medications.
• • 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 malignancy.
• • Acute gastroenteritis or gastrointestinal surgery within the past 12 months.
• Prior Medication:
• Excluded:
• • 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.