NCT00000749

Brief Summary

To evaluate in healthy volunteers the safety and immune response to 200 mcg gp120 candidate vaccine in MF59 emulsion without MTP-PE at 0, 1 and 6 months. Preliminary evaluations of two dose levels of gp120 administered to volunteers in protocol VEU 007A indicate that a gp120 dose of potentially greater immunogenicity may be of interest.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
14

participants targeted

Target at below P25 for phase_1 hiv-infections

Geographic Reach
1 country

2 active sites

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

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

October 30, 2012

Status Verified

October 1, 2012

First QC Date

November 2, 1999

Last Update Submit

October 29, 2012

Conditions

HIV Infections

Keywords

Vaccines, SyntheticHIV Envelope Protein gp120AIDS VaccinesHIV SeronegativityHIV Preventive Vaccine

Interventions

rgp120/HIV-1 SF-2BIOLOGICAL

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Subjects must have:
  • Normal history and physical exam.
  • Negative ELISA for HIV.
  • Normal cell-mediated immune responses using Merieux skin test.
  • Normal urinalysis.

You may not qualify if:

  • Co-existing Condition:
  • Subjects with the following conditions are excluded:
  • Evidence of psychological or psychiatric problems that may lead to noncompliance with study requirements.
  • Positive syphilis serology. If serology is documented as a false positive or is due to a remote (\> 6 months) treated infection, subject is eligible.
  • Circulating hepatitis B surface antigen.
  • Subjects with the following prior conditions are excluded:
  • History of immunodeficiency, chronic illness, autoimmune disease, or use of immunosuppressive medications.
  • History of anaphylaxis or other adverse reactions to vaccines.
  • Prior Medication:
  • Excluded:
  • Prior HIV vaccines.
  • Immunoglobulins or vaccines within the past 3 months.
  • Experimental agents within the past 30 days.
  • Prior Treatment:
  • Excluded:
  • +5 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Vanderbilt Univ Hosp

Nashville, Tennessee, 37232, United States

Location

Univ of Washington / Pacific Med Ctr

Seattle, Washington, 98144, 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 Officials

  • Graham B

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

October 30, 2012

Record last verified: 2012-10

Locations

US(2)