NCT00002231

Brief Summary

The purpose of this study is to see if it is safe to give GENEVAX-HIV, a new HIV vaccine, to HIV-negative volunteers. This study will also look at how this vaccine affects the immune system of these volunteers.

Trial Health

80
On Track

Trial Health Score

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

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

May 1, 2000

First QC Date

November 2, 1999

Last Update Submit

June 23, 2005

Conditions

HIV InfectionsHIV Seronegativity

Keywords

Injections, IntramuscularHIV AntibodiesImmunity, CellularAIDS VaccinesHIV SeronegativityDose-Response Relationship, ImmunologicVaccines, DNA

Interventions

APL 400-003BIOLOGICAL

Eligibility Criteria

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

You may qualify if:

  • You may be eligible for this study if you:
  • Are 18 - 60 years old.
  • Are HIV-negative and in good health.
  • Are able to understand how infections such as HIV are spread.
  • Agree to use effective methods of birth control during the study.

You may not qualify if:

  • You will not be eligible for this study if you:
  • Have hepatitis B or C.
  • Have any condition that may prevent you from completing the study.
  • Are allergic to bupivacaine, vaccines, or certain local anesthetics.
  • Have taken certain medications or have received certain therapies that may affect your immune system.
  • Have an immune system disorder or have received therapy for an immune system disorder.
  • Have been exposed to HIV within 6 months prior to study entry.
  • Have received an experimental HIV vaccine or any other experimental treatment within 30 days prior to study entry.
  • Have received blood transfusions within 6 months prior to study entry.
  • Abuse alcohol or drugs or have an uncontrolled psychiatric disorder.
  • Are pregnant or breast-feeding.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ of Pennsylvania Med Ctr

Philadelphia, Pennsylvania, 19104, 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

  • RR MacGregor

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
NONE
Purpose
PREVENTION
Sponsor Type
INDUSTRY

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Last Updated

June 24, 2005

Record last verified: 2000-05

Locations

US(1)