San Francisco, California 94110

  • HIV Infections


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.

Study 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.


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.



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San Francisco, California 94110
United States

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Site Status: N/A

Data Source:

Date Processed: June 20, 2021

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