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

• Status: Completed
• Trial end date: 2001-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
• Treatments: Bupivacaine; Vaccines

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).