H7 Influenza Prime-Boost Regimens in Healthy Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or With Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime With MIV Boost Compared to MIV Prime With MIV Boo...
Condition: Influenza
MeSH terms: Influenza, Human; Influenza in Birds
Study type: Interventional
Phase: Phase 1

Summary: 
      Background:<TAB>

      - Flu virus that causes disease in birds can sometimes spread to people. It can cause severe
      illness, even death. Vaccines are used to try to create resistance to such infections.
      Researchers want to test a new vaccination strategy, combining two different vaccine types,
      the H7 DNA Vaccine (DNA vaccine) and H7N9 Monovalent Inactivated Vaccine (MIV), to see if one
      of two combinations offer better protection against a certain type of bird flu in humans when
      compared to vaccination using two doses of MIV alone.

      Objectives:

        -  To see if 2 vaccines for bird flu, are safe and tolerable for humans.

        -  To study immune responses to these vaccines.

      Eligibility:

      - Healthy adults 18 60 years old.

      Design:

        -  Participants will be screened through a separate protocol.

        -  Participants will be randomly assigned to 1 of 3 groups. Each group will get a different
           combination of vaccines.

        -  Participants will have about 8 clinic visits. Each visit takes 2 4 hours. Blood will be
           drawn at some visits. Urine samples may be collected.

        -  Participants will receive vaccinations at 2 of the visits, 16 weeks apart.

        -  The H7N9 MIV will be injected in the upper arm using a needle and syringe. The DNA
           vaccine will be injected in the upper arm using a device that delivers the vaccine
           through the skin by pressure instead of a needle.

        -  Participants will be observed for at least 30 minutes after each vaccination.

        -  Soon after each vaccination, participants will get 1 2 phone calls, come to clinic for
           evaluation, and complete a diary at home for 1 week. They will record their temperature
           and symptoms and look at the injection site daily.

        -  Participants will have follow-up blood tests.
    

Detailed description: 
      VRC 315 STUDY:

      A Phase I Open-Label, Randomized Study of H7 Influenza Prime-Boost Regimens in Healthy
      Adults: Recombinant H7 DNA Plasmid Vaccine, VRC-FLUDNA071-00-VP, Administered Alone or with
      Monovalent Influenza Subunit Virion H7N9 Vaccine (MIV) as Prime with MIV Boost Compared to
      MIV Prime with MIV Boost

      STUDY DESIGN:

      This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and
      immunogenicity of prime-boost vaccination regimens against H7N9 Influenza. A vaccination
      regimen with the VRC-FLUDNA071-00-VP (H7 DNA) vaccine administered alone or concurrently in
      different arms with A/Shanghai/2/2013(H7N9) (MIV) as prime followed by inactivated MIV boost
      will be compared to MIV-MIV prime-boost with a 16 week boost interval. The primary hypothesis
      is that all the H7 DNA prime-MIV boost, DNA+MIV prime-MIV boost, and MIV-MIV study regimens
      will be safe for human administration. A secondary hypothesis is that the H7 DNAMIV regimen
      will elicit a greater frequency and/or magnitude of antibody against H7 than the MIV-MIV
      regimen. The primary objective is to evaluate the safety and tolerability in healthy adults
      of the investigational vaccine regimens. Secondary objectives are related to the
      immunogenicity of the vaccination regimens.

      PRODUCT DESCRIPTION:

      The investigational VRC-FLUDNA071-00-VP vaccine was developed by VRC, NIAID and is composed
      of a single closed-circular DNA plasmid that encodes the H7 hemagglutinin (HA) protein of
      A/Anhui/1/2013 (H7N9) influenza, and is supplied in single dose vials at a concentration of 4
      mg/mL. H7 DNA vaccinations will be 4 mg administered as a 1 mL intramuscularly (IM) using the
      Biojector o 2000 Needle-Free Injection Management System (Biojector). The inactivated H7N9
      vaccine is monovalent subunit virion vaccine, A/Shanghai/2/2013(H7N9) MIV, manufactured by
      Sanofi Pasteur, Inc (Swiftwater, PA), and supplied at 30 mcg/0.5 mL per vial. The H7N9 MIV
      vaccinations will be 45 mcg administered as a 0.75 mL IM injection using needle and syringe.
      All injections will be in the deltoid muscle.

      SUBJECTS:

      A total of up to 36 healthy adults, ages 18-60 years will be enrolled.

      STUDY PLAN:

      Subjects will be randomized equally into the three study groups and will receive two
      vaccinations as shown in the schema. The protocol requires 7 clinic visits and a telephone
      follow-up contact after each study injection. Durability of immune response will be followed
      through Study Week 28.

      STUDY DURATION:

      Subjects will be evaluated for safety and immune responses throughout the study for 12 weeks
      following the boost. Duration of time on study will be 28 weeks.
    

Intervention name(s): A/Shanghai/02/2013 (H7N9) MIV; VRC-FLUDNA071-00-VP
Intervention type(s): Biological; Biological
Intervention description(s): Monovalent Influenza Subvirion Vaccine for H7N9 avian influenza (H7N9 MIV); H7 DNA Vaccine
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: A/Anhui/1/2013 (H7N9); Antibody Response; Avian Influenza; A/Shanghai/2/2013 (H7N9); Immunogenicity