NCT00001088

Brief Summary

To evaluate the safety, tolerability and immunogenicity in humans of the APL-400-047 vaccine when administered intramuscularly by needle and syringe at 1 of 3 doses or by Biojector at the intermediate dose. \[AS PER AMENDMENT 07/98: To evaluate the tolerability, safety, and immunogenicity of an increased dose in an additional group of volunteers.\] DNA-based immunization mimics live-attenuated virus vaccination by stimulation of both the humoral and cellular arms of the immune system; thus, potentially providing the advantages of a live virus vaccination but without the potential risks. It is essential that novel vaccine strategies (including DNA-based immunizations) continue to be developed and enter Phase I human testing because to date, no candidate vaccine from any of the approximately 30 AVEG Phase I or II trials has progressed to a Phase III efficacy trial. Use of a Biojector jet gun for vaccine delivery may also have potential psychological, comfort, safety and immunologic advantages over the traditional needle and syringe method of delivery.

Trial Health

87
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

Timeline
Completed

Started Jul 1997

Typical duration for phase_1 hiv-infections

Geographic Reach
1 country

4 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

Study Start

First participant enrolled

July 1, 1997

Completed
2.3 years until next milestone

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2001

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
7 months until next milestone

First Posted

Study publicly available on registry

August 31, 2001

Completed
Last Updated

September 29, 2008

Status Verified

September 1, 2008

Enrollment Period

3.6 years

First QC Date

November 2, 1999

Last Update Submit

September 26, 2008

Conditions

HIV Infections

Keywords

Injections, IntramuscularAIDS VaccinesHIV SeronegativityDose-Response Relationship, ImmunologicFusion Proteins, gag-polVaccines, DNAHIV Preventive Vaccine

Interventions

APL 400-047BIOLOGICAL
Bupivacaine hydrochlorideDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must have:
  • Negative ELISA for HIV within 8 weeks of immunization.
  • CD4 count \>= 400 cells/mm3.
  • Normal history and physical examination.
  • Negative for Hepatitis B surface antigen.

You may not qualify if:

  • Co-existing Condition:
  • Patients with the following conditions and symptoms are excluded:
  • Positive for anti-dsDNA antibodies.
  • Medical or psychiatric condition or occupational responsibilities that preclude compliance with the protocol.
  • Present psychosis.
  • Active syphilis (eligible if serology documented to be a false positive or due to remote, i.e., \> 6 months treated, infection).
  • Active tuberculosis (eligible if positive purified protein derivative test and normal chest x-ray showing no evidence of TB and not requiring isoniazid therapy).
  • Concurrent Medication:
  • Excluded:
  • Immunosuppressive medications.
  • Patients with the following prior conditions are excluded:
  • History of immunodeficiency, chronic illness, or autoimmune disease.
  • History of cancer unless there has been surgical excision followed by a sufficient observation period to give a reasonable assurance of cure.
  • History of suicide attempts, recent suicidal ideation or past psychosis.
  • History of anaphylaxis or other serious adverse reactions to vaccines.
  • +16 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Univ of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Univ of Rochester Med Ctr

Rochester, New York, 14642, United States

Location

Vanderbilt Univ Hosp

Nashville, Tennessee, 37232, United States

Location

Univ of Washington / Pacific Med Ctr

Seattle, Washington, 98144, United States

Location

Related Publications (2)

  • Goepfert P, Mulligan M, Corey L, Graham B, Evans T, Weinhold K, Stablein D, Ginsberg R. AVEG 031: phase I evaluation of a gag-pol facilitated DNA vaccine for HIV-1 prevention. Int Conf AIDS. 1998;12:635 (abstract no 33216)

    BACKGROUND

  • Tellez I, Sabbaj S, Bansal A, Goepfert P, Evans T, Graham B, Ginsberg R, Weiner D, Corey L, Weinhold K, Mulligan M. HIV-specific T-cell responses in seronegative volunteers immunized with an HIV-1 gag-pol DNA vaccine. 7th Conference on Retroviruses and Opportunistic Infections. 2000 Jan 30-Feb 2 (abstract no 656)

    BACKGROUND

MeSH Terms

Conditions

HIV Infections

Interventions

Bupivacaine

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

AnilidesAmidesOrganic ChemicalsAniline CompoundsAmines

Study Officials

  • Mulligan M

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 1
Masking
DOUBLE
Purpose
PREVENTION
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

August 31, 2001

Study Start

July 1, 1997

Primary Completion

February 1, 2001

Study Completion

February 1, 2001

Last Updated

September 29, 2008

Record last verified: 2008-09

Locations

US(4)