NCT00076947

Brief Summary

The purpose of this study is to determine the safety of a new HIV vaccine. The vaccine in this study is mixed with a chemical called alum to improve the body's response to the vaccine. Healthy adults who are not infected with HIV may participate in the study.

Trial Health

80
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2003

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 6, 2004

Completed
3 days until next milestone

First Posted

Study publicly available on registry

February 9, 2004

Completed
Last Updated

March 21, 2008

Status Verified

March 1, 2005

First QC Date

February 6, 2004

Last Update Submit

March 20, 2008

Conditions

HIV Infections

Keywords

HIV Preventive VaccineHIV SeronegativityProtein

Interventions

EnvProBIOLOGICAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • HIV uninfected
  • Normal medical history and physical exam
  • Normal complete blood count
  • Normal liver function
  • Normal renal function
  • Normal serum creatine phosphokinase (CPK)
  • Availability for at least 1 year follow-up

You may not qualify if:

  • History of immunosuppressive illness, chronic illness, or use of any immunosuppressive medications
  • Medical or psychiatric condition or occupational responsibilities which preclude compliance with the study
  • Live attenuated vaccines within 60 days of study entry
  • Use of experimental agents within 30 days of study entry

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Jude Children's Research Hospital

Memphis, Tennessee, 38105, United States

Location

Related Publications (3)

  • Slobod KS, Lockey TD, Howlett N, Srinivas RV, Rencher SD, Freiden PJ, Doherty PC, Hurwitz JL. Subcutaneous administration of a recombinant vaccinia virus vaccine expressing multiple envelopes of HIV-1. Eur J Clin Microbiol Infect Dis. 2004 Feb;23(2):106-10. doi: 10.1007/s10096-003-1075-3. Epub 2004 Jan 20.

    PMID: 14735404BACKGROUND

  • Brown SA, Stambas J, Zhan X, Slobod KS, Coleclough C, Zirkel A, Surman S, White SW, Doherty PC, Hurwitz JL. Clustering of Th cell epitopes on exposed regions of HIV envelope despite defects in antibody activity. J Immunol. 2003 Oct 15;171(8):4140-8. doi: 10.4049/jimmunol.171.8.4140.

    PMID: 14530336BACKGROUND

  • Zhan X, Slobod KS, Surman S, Brown SA, Lockey TD, Coleclough C, Doherty PC, Hurwitz JL. Limited breadth of a T-helper cell response to a human immunodeficiency virus envelope protein. J Virol. 2003 Apr;77(7):4231-6. doi: 10.1128/jvi.77.7.4231-4236.2003.

    PMID: 12634380BACKGROUND

Related Links

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

  • Karen Slobod, MD

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Sponsor Type
NIH

Study Record Dates

First Submitted

February 6, 2004

First Posted

February 9, 2004

Study Start

August 1, 2003

Last Updated

March 21, 2008

Record last verified: 2005-03

Locations

US(1)