HIV-1 Vaccine Test in Uninfected Adult Volunteers
Condition: HIV Seronegativity; AIDS Vaccines
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test the safety of an experimental vaccine against HIV and examine whether it
      induces an immune response to HIV. A vaccine is a substance given to try to create resistance
      or immunity to a disease or infection. The vaccine in this study is made from DNA (genetic
      material) of four HIV proteins called 'gag', 'pol', 'Nef', and 'Env'. Injected into a human,
      the viral DNA instructs the body to make small amounts of some HIV proteins. This study will
      see if the body then creates an immune response to these proteins. Study participants cannot
      catch HIV or AIDS from the DNA vaccine or any proteins made from it.

      Healthy normal volunteers between 18 and 40 years of age may be eligible for this study.
      Candidates will be screened with a medical history, physical examination and blood and urine
      tests. Women will also have a pregnancy test. Women enrolled in the study must either be
      infertile (e.g., due to menopause or hysterectomy) or must agree either to abstain from
      heterosexual sex or to practice birth control for at least 21 days before beginning the study
      and throughout its duration.

      Participants will be randomly assigned to receive either the experimental vaccine or a
      placebo (a salt solution that does not contain any active substance) and will be divided into
      three groups, based on their entry into the study. Of the first seven people enrolled (Group
      1), five will receive a 2-mg dose of vaccine and two will receive placebo. If the vaccine is
      safe at this dose, then in Group 2, five people will receive a 4-mg dose of vaccine and two
      will receive placebo. If this dose is safe, then in Group 3, thirty people will receive an
      8-mg dose of vaccine and six will receive placebo.

      All participants will receive three injections in an upper arm muscle-one injection a month
      for three months-with a needle-less device called a Biojector 2000® (Registered Trademark).
      At the time of each injection, participants will be observed for at least 1 hour after
      immunization. At home, they will record their temperature and any symptoms they may
      experience, including any effects at the injection site, for at least 7 days, or as long as
      the symptoms remain. If symptoms occur, participants will report them immediately to the
      clinic staff and, if necessary, come to the clinic for an examination.

      Participants will have about 10 clinic visits during the study. Most visits will last about 2
      hours; those on vaccination days will last about 4 hours. ...
    

Detailed description: 
      This is a Phase I, randomized, controlled, double-blinded, dose-escalation study to examine
      tolerability, dose, and immune response of an HIV DNA plasmid vaccine. The hypothesis is that
      this vaccine will be safe for human administration and elicit immune responses to HIV. The
      primary objective is to evaluate the safety and tolerability in humans of VRC-HIVDNA009-00-VP
      and secondary objectives are to evaluate the immunogenicity of the vaccine and social impact
      of participating in an HIV-1 vaccine trial.
    

Intervention name(s): VRC-HIVDNA009-00-VP
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Healthy; HIV-Negative; Placebo-Controlled; Volunteer; Dose-Escalation; HIV Seronegativity; Healthy Volunteer; HV