Search / Trial NCT00002204

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

Launched by CHIRON CORPORATION · Aug 30, 2001

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Trial Information

Current as of December 06, 2024

Completed

Keywords

Reference Values Placebos Aids Vaccines Hiv Core Protein P24 Hiv Seronegativity Mf59 Oil Emulsion

ClinConnect 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.

Gender

ALL

Eligibility 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.

About Chiron Corporation

Chiron Corporation, a pioneering biotechnology company, specializes in the development and commercialization of innovative therapeutic solutions and diagnostic products. With a strong focus on infectious diseases and cancer, Chiron leverages advanced research and development to address unmet medical needs. The company is committed to clinical excellence and adheres to the highest standards of regulatory compliance, ensuring that its trials are conducted with integrity and scientific rigor. Through collaboration with healthcare professionals and academic institutions, Chiron Corporation strives to enhance patient outcomes and contribute to the advancement of medical science.

Locations

Omaha, Nebraska, United States

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0

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