Clinical trial NCT00002204: A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
Official title: A Phase I, Observer-Blind, Placebo-Controlled Study of the Chiron Vaccine HIV p24/MF59 Administered to Healthy HIV-Seronegative Adults
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: HIV Infections
HIV Seronegativity
Keywords: Reference Values
Placebos
AIDS Vaccines
HIV Core Protein p24
HIV Seronegativity
MF59 oil emulsion
Lead sponsor: NIH AIDS Clinical Trials Information Service
Sponsor class: INDUSTRY
First posted: 2001-08-31
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: yes
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.

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 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.

Primary outcomes:
Secondary outcomes:
Other outcomes:
Locations:
city: Omaha
country: United States
facility: Creighton Univ Med Ctr / Ped Infect Disease Div
state: Nebraska
Study officials:
References: