Status:

COMPLETED

A Phase I Safety and Immunogenicity Trial of the Facilitated HIV-1 Gag-Pol DNA Vaccine (APL-400-047, Apollon, Inc.) Given Intramuscularly by Needle and Syringe or Biojector 2000 Needle-Free Jet Injection System in HIV-1 Uninfected Adult Volunteers

Lead Sponsor:

National Institute of Allergy and Infectious Diseases (NIAID)

Conditions:

HIV Infections

Eligibility:

All Genders

18-60 years

Phase:

PHASE1

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...

Detailed Description

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 va...

Eligibility Criteria

Inclusion Criteria

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.

Exclusion Criteria

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.
  • History of severe allergic reaction to any substance, requiring hospitalization or emergent medical care (e.g., Stevens-Johnson syndrome, bronchospasm, or hypotension).
  • Hypersensitivity to bupivacaine or other amide-type anesthetics.

Prior Medication:

Excluded:

  • Prior receipt of HIV-1 vaccines or placebo recipient in a previous HIV vaccine trial.
  • Use of experimental agents within 30 days prior to study.
  • Live attenuated vaccines within 60 days of study.
  • Medically indicated subunit or killed vaccines (e.g., influenza, pneumococcal) within 2 weeks prior to study.

Prior Treatment:

Excluded:

Receipt of blood products or immunoglobulin in the past 6 months.

Risk Behavior:

Excluded:

Volunteers having identifiable higher risk behavior for HIV infection as determined by screening questions designed to identify risk factors for HIV infection, specifically:

  • History of injection drug use within the last 12 months prior to enrollment.
  • Higher or intermediate risk sexual behavior as defined by the AVEG (i.e., meeting the criteria for AVEG Risk Group C or D).

Key Trial Info

Start Date :

July 1 1997

Trial Type :

INTERVENTIONAL

End Date :

February 1 2001

Estimated Enrollment :

40 Patients enrolled

Trial Details

Trial ID

NCT00001088

Start Date

July 1 1997

End Date

February 1 2001

Last Update

September 29 2008

Active Locations (4)

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Page 1 of 1 (4 locations)

1

Univ of Alabama at Birmingham

Birmingham, Alabama, United States, 35294

2

Univ of Rochester Med Ctr

Rochester, New York, United States, 14642

3

Vanderbilt Univ Hosp

Nashville, Tennessee, United States, 37232

4

Univ of Washington / Pacific Med Ctr

Seattle, Washington, United States, 98144