NCT00002204

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P50-P75 for phase_1 hiv-infections

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.8 years until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

June 24, 2005

Status Verified

June 1, 1999

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV InfectionsHIV Seronegativity

Keywords

Reference ValuesPlacebosAIDS VaccinesHIV Core Protein p24HIV SeronegativityMF59 oil emulsion

Interventions

HIV p24/MF59 VaccineBIOLOGICAL

Eligibility Criteria

Age18 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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).

You may not qualify if:

  • 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.
  • \. Immunosuppressive medications.
  • Live, attenuated vaccine within 60 days of study entry.
  • NOTE:
  • 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.:
  • +1 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Creighton Univ Med Ctr / Ped Infect Disease Div

Omaha, Nebraska, 68178, United States

Location

MeSH Terms

Conditions

HIV Infections

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsSexually Transmitted Diseases, ViralSexually Transmitted DiseasesLentivirus InfectionsRetroviridae InfectionsRNA Virus InfectionsVirus DiseasesGenital DiseasesUrogenital DiseasesImmunologic Deficiency SyndromesImmune System Diseases

Study Design

Study Type
interventional
Phase
phase 1
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 1999-06

Locations

US(1)