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

Summary: 
      This study will evaluate whether an experimental vaccine intended to prevent HIV infection is
      safe and whether it causes any side effects. It will also examine whether the vaccine, called
      VRC-HIVDNA016-00-VP, causes an immune response, and will monitor participants for the social
      impact of being in an HIV vaccine study. VRC-HIVDNA016-00-VP contains synthetic DNA that
      codes for parts of four HIV proteins. It also contains a "promoter" piece of DNA that is
      needed to start protein production. The promoter DNA is also synthetic and is like the
      promoter in another virus called cytomegalovirus (CMV). The vaccine contains no live HIV
      virus or CMV and cannot cause either of these illnesses.

      Healthy volunteers between 18 and 44 years old who are HIV-negative may be eligible for this
      32-week study. Candidates are screened with a medical history, physical examination, and
      blood and urine tests.

      Participants receive three injections of the experimental vaccine approximately 28 days
      apart. The injections are given with a system called the Biojector 2000 that delivers the
      vaccine through the skin into the muscle without the use of a needle. Subjects are observed
      for side effects for at least 30 minutes after each vaccination and are required to telephone
      the clinic staff 1 to 2 days after the injection to report how they are doing. In addition,
      they are given a diary card to take home, on which they record their temperature and any
      symptoms daily for five days.

      Participants return to the clinic two weeks after each injection. They return the completed
      diary card and are checked for any health changes or problems since the last visit. They are
      asked how they are feeling and what medications, if any, they have taken. Blood and urine
      samples are collected. Some subjects may be asked to have laboratory tests between regular
      visits if needed to evaluate a change in health. Participants are also asked about any social
      effects they may have experienced as a result of their participation in the study.
    

Detailed description: 
      Study Design: This is a Phase I open label study to evaluate safety, tolerability, and immune
      response of a 6-plasmid multiclade HIV-1 DNA vaccine, VRC-HIVDNA016-00-VP. The hypothesis is
      that this regimen will be safe for human administration and elicit immune responses to HIV-1
      clade B Gag, Pol and Nef proteins, as well as clades A, B and C Env proteins. The primary
      objective is to evaluate the safety and tolerability in humans of the investigational vaccine
      and secondary objectives are to evaluate the immunogenicity of the vaccine as measured by
      intracellular cytokine staining (ICS) in the 4 weeks after the second or third dose of
      vaccine and the social impact of participating in an HIV-1 vaccine trial.

      Product Description: VRC-HIVDNA016-00-VP is composed of 6 closed, circular DNA plasmids that
      are each 16.67 percent (by weight) of the vaccine. Each of the 6 plasmids in this vaccine
      expresses a single gene product. Plasmids VRC 4401, VRC 4409 and VRC 4404 are designed to
      express clade B HIV-1 Gag, Pol and Nef, respectively. VRC 5736, VRC 5737, and VRC 5738 are
      designed to express HIV-1 Env glycoprotein from clade A, clade B, and clade C, respectively.
      Vaccine vials will be supplied at 4 mg/mL. Each DNA vaccination will be 1 mL of vaccine
      administered intramuscularly (in deltoid muscle) using the Biojector 2000 Needle-Free
      Injection Management System.

      Subjects: Healthy adult volunteers (18 to 44 years old) will be enrolled.

      Study Plan: Fifteen volunteers will be enrolled, as shown in the schema:

      Name of Vaccine: VRC-HIVDNA016-00-VP

      Number of Subjects: 15

      Vaccine Injection Schedule: (at least 21 days between injections)

      Day 0: 4 mg

      Day 28 plus or minus 7: 4 mg

      Day 56 plus or minus 7: 4 mg

      Study Duration: 32 weeks clinical follow-up for each participant.

      Study Endpoints: The primary endpoint is safety of the regimen; secondary endpoints are

      cellular immune responses as measured by ICS within the first 4 weeks after the second and

      third doses and social impact at Week 32. Exploratory analyses will include HIV-specific

      antibody assays, ICS or other immunological assays at intervals between Day 0 and Week 32.
    

Intervention name(s): VRC-HIVDNA016-00-VP
Intervention type(s): Drug
Primary purpose: Treatment
Keywords: Healthy; Virus; T-Cells; HIV-Negative; Immunity; Healthy Volunteer; HV; HIV Preventive Vaccine; HIV Seronegativity