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

November 2, 1999
June 23, 2005
Not Provided
Not Provided
Not Provided
Not Provided
Complete list of historical versions of study NCT00002204 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults

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.

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.

Interventional
Phase 1
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Primary Purpose: Prevention
  • HIV Infections
  • HIV Seronegativity
Biological: HIV p24/MF59 Vaccine
Not Provided
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
Not Provided
Not Provided

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.
Both
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00002204
095, V24P1
Not Provided
Not Provided
Chiron Corporation
Not Provided
Not Provided
NIH AIDS Clinical Trials Information Service
June 1999

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP