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
Condition: HIV Infections
MeSH terms: HIV Infections
Study type: Interventional
Phase: Phase 1

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.
    

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 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.

      A total of 40 volunteers receive four immunizations each (at months 0, 1, 2 and 6) as
      follows:

      10 volunteers are enrolled at the 100 microgram dose given intramuscularly (IM) by needle and
      syringe. If this dose appears safe and well tolerated through Day 14, 20 more volunteers are
      enrolled at the 300 microgram dose; 10 receiving vaccine administered by needle and syringe,
      10 receiving vaccine administered by Biojector. If the 300 microgram dose appears safe and
      well tolerated through Day 14 in the 10 volunteers who receive intramuscular (IM) injections
      with needle and syringe, an additional group of volunteers are enrolled at the 1000 microgram
      dose given with needle and syringe. NOTE: Within each group of 10 volunteers, 8 receive
      APL-400-047, 2 receive control preparation (bupivacaine carrier alone). [AS PER AMENDMENT
      07/98: An additional group of 12 volunteers will be treated at a dose of 3000 micrograms
      administered by needle and syringe. Ten of these volunteers will receive APL-400-047
      formulated with bupivacaine as a facilitating agent; the remaining 2 patients will receive
      control preparation (bupivacaine carrier alone).] [AS PER AMENDMENT 4/27/99: Volunteers
      previously primed with either 300 or 1000 micrograms of the APL-400-047 vaccine receive an
      additional dose of DNA (or control, for control volunteers in the original protocol) followed
      one month later by two monthly canarypox (or placebo for control volunteers in the original
      protocol) boosts.]
    

Intervention name(s): APL 400-047; Bupivacaine hydrochloride
Intervention type(s): Biological; Drug
Intervention MeSH terms: Bupivacaine
Masking: Double
Primary purpose: Prevention
Keywords: Injections, Intramuscular; AIDS Vaccines; HIV Seronegativity; Dose-Response Relationship, Immunologic; Fusion Proteins, gag-pol; Vaccines, DNA; HIV Preventive Vaccine