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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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HIV Infections

Intervention / Treatment
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* Biological: HIV-1 Peptide Vaccine, Microparticulate Monovalent
* Biological: rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HIV-1 Peptide Vaccine, Microparticulate Monovalent|nan|
|Biological: rgp120/HIV-1MN Monovalent Octameric V3 Peptide Vaccine|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vaccines, Synthetic, HIV-1, HIV Envelope Protein gp120, AIDS Vaccines, HIV Seronegativity