Expired Study
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Omaha, Nebraska 68178


Purpose:

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.


Study summary:

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.


Criteria:

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.


NCT ID:

NCT00002204


Primary Contact:

N/A


Backup Contact:

N/A


Location Contact:

Omaha, Nebraska 68178
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 20, 2017

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