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

HIV Infections Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00002204
• Other study ID #: 095
• Secondary ID: V24P1
• Status: Completed
• Phase: Phase 1
• First received: November 2, 1999
• Last updated: June 23, 2005

Study information

• Verified date: June 1999
• Source: NIH AIDS Clinical Trials Information Service
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 50 Years

Eligibility

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.

Study Design

Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Primary Purpose: Prevention

Related Conditions & MeSH terms

• HIV Infections
• HIV Seronegativity

Intervention

Biological:
• HIV p24/MF59 Vaccine

Locations

Country	Name	City	State
United States	Creighton Univ Med Ctr / Ped Infect Disease Div	Omaha	Nebraska

Sponsors (1)

Lead Sponsor	Collaborator
Chiron Corporation

Country where clinical trial is conducted

United States,