Phase I Study of a Vaccine for Severe Acute Respiratory Syndrome (SARS)
Condition: Healthy
Study type: Interventional
Phase: Phase 1

Summary: 
      This study will test whether an experimental vaccine to protect against severe acute
      respiratory syndrome (SARS) is safe, causes any side effects, and causes an immune response.
      SARS affects the respiratory system, usually starting with fever and muscle aches. Patients
      may get a dry cough and have difficulty breathing. Infection may be mild, but it can lead to
      death.

      Vaccines contain substances from an infectious agent, such as a virus, that, when injected
      into a person's body, stimulates production of antibodies that create resistance, or
      immunity, to that agent. The vaccine in this study contains genetic material (DNA) that codes
      for a protein found in the virus that causes SARS. Injected into a muscle, it instructs the
      body to make a small amount of a SARS protein. The vaccine is made from just one small part
      of the code for one SARS protein; a person cannot get SARS from the vaccine.

      Normal volunteers between 18 and 50 years of age who are in general good health may be
      eligible for this 32-week study. Candidates are screened with a physical examination and
      blood and urine tests.

      Participants have nine clinic visits during the study. They receive three vaccine injections,
      given with a system called the Bioinjector 2000® (Registered Trademark), which delivers the
      vaccine through the skin without the use of a needle. Following each injection, participants
      take home a diary card, on which they record their temperature and any vaccine side effects
      daily for 5 days. Participants must immediately report any symptoms to a study physician,
      and, if necessary, go to the clinic for an examination. Participants have the following tests
      and procedures:

        -  Vaccine injections (study day 0, around week 4, and around week 8, with at least 21 days
           between injections)

        -  Medical history and, if needed, physical examination (study day 0 and weeks 2, 4, 6, 8,
           10, 12, 24, and 32)

        -  Check of vital signs and weight (study day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32)

        -  Lymph node examination (day 0 and weeks 2, 4, 6, 8, 10 and 12)

        -  Blood draw (study day 0 and weeks 2, 4, 6, 8, 10, 12, 24 and 32)

        -  Pregnancy test for women (day 0 and weeks 4, 8 and 32)

        -  Urine sample (day 0 and weeks 2, 4, 6, 8, 10)
    

Detailed description: 
      Study Design: This is a Phase I open label study to evaluate safety, tolerability, and immune
      response of a recombinant DNA vaccine, VRC-SRSDNA015-00-VP. The hypothesis is that this
      regimen will be safe for human administration and elicit immune responses to the SARS
      coronavirus (CoV) spike (S) protein. The primary objective is to evaluate the safety and
      tolerability in humans of the investigational vaccine. Secondary and exploratory objectives
      are related to the immunogenicity of the study vaccine.

      Product Description: VRC-SRSDNA015-00-VP is composed of a single closed, circular DNA plasmid
      that is based on the S protein of SARS-CoV. 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 50 years old) will be enrolled.

      Study Plan: Ten volunteers will be enrolled and receive 3 injections on the schedule shown in
      the schema. The protocol requires nine clinic visits and three telephone follow-up contacts.

      Study Duration: 32 weeks clinical follow-up for each participant.

      Study Endpoints: The primary endpoint is safety of the regimen; secondary immunogenicity
      endpoints are an intracellular cytokine staining (ICS) assay for SARS specific T cell
      responses and an assay for antibody-dependent enhancement of virus uptake. The principal
      timepoints for ICS are Week 0 (baseline) and Weeks 6, 8, 10 and 12. ICS at other study
      timepoints, as well as other immunogenicity assays through Week 32, will be completed as
      exploratory evaluations.
    

Intervention name(s): Blood Test; Urine Test; Physical Exam; Vaccine; VRC-SRSDNA015-00-VP
Intervention type(s): Procedure; Procedure; Procedure; Drug; Drug
Primary purpose: Treatment
Keywords: Coronavirus; Healthy; Immunity; Preventive; Virus; Healthy Volunteer; HV