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

This study has been completed.
Sponsor:
Information provided by:
NIH AIDS Clinical Trials Information Service
ClinicalTrials.gov Identifier:
NCT00002204
First received: November 2, 1999
Last updated: June 23, 2005
Last verified: June 1999
  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.


Condition Intervention Phase
HIV Infections
HIV Seronegativity
Biological: HIV p24/MF59 Vaccine
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
Official Title: A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults

Resource links provided by NLM:


Further study details as provided by NIH AIDS Clinical Trials Information Service:

Estimated Enrollment: 40
Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00002204

Locations
United States, Nebraska
Creighton Univ Med Ctr / Ped Infect Disease Div
Omaha, Nebraska, United States, 68178
Sponsors and Collaborators
Chiron Corporation
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00002204     History of Changes
Other Study ID Numbers: 095, V24P1
Study First Received: November 2, 1999
Last Updated: June 23, 2005
Health Authority: United States: Food and Drug Administration

Keywords provided by NIH AIDS Clinical Trials Information Service:
Reference Values
Placebos
AIDS Vaccines
HIV Core Protein p24
HIV Seronegativity
MF59 oil emulsion

Additional relevant MeSH terms:
HIV Infections
Acquired Immunodeficiency Syndrome
Lentivirus Infections
Retroviridae Infections
RNA Virus Infections
Virus Diseases
Sexually Transmitted Diseases, Viral
Sexually Transmitted Diseases
Immunologic Deficiency Syndromes
Immune System Diseases
Slow Virus Diseases

ClinicalTrials.gov processed this record on August 01, 2014