A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults

Conditions
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HIV Infections, HIV Seronegativity

Intervention / Treatment
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* Biological: HIV p24/MF59 Vaccine


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria Volunteers must have: Good health as determined by medical history, physical examination, and clinical judgment. 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). Exclusion Criteria Co-existing Condition: 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 components. 1. Immunosuppressive medications. Live, attenuated vaccine within 60 days of study entry. NOTE: 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 disease.

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
Intervention Model: Parallel Assignment


Arms and Interventions

| Intervention/Treatment |
| --- |
|Biological: HIV p24/MF59 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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Reference Values, Placebos, AIDS Vaccines, HIV Core Protein p24, HIV Seronegativity, MF59 oil emulsion