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

Completed · Phase 1

Conditions studied: HIV Infections

In brief

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.

Key facts

Study ID

NCT00001088

Run by

National Institute of Allergy and Infectious Diseases (NIAID)

People needed

40

Starts

1997-07-01

Expected to finish

2001-02-01

Last updated by the study team

2008-09-29

Who can join

Age: 18 and older, up to 60. Sex: any. Healthy volunteers: accepted.

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.
• 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:

Where it is running

• Univ of Alabama at Birmingham — Birmingham, Alabama, United States
• Univ of Rochester Med Ctr — Rochester, New York, United States
• Vanderbilt Univ Hosp — Nashville, Tennessee, United States
• Univ of Washington / Pacific Med Ctr — Seattle, Washington, United States

Full record on ClinicalTrials.gov

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