Vaccine for Prevention of Bird Flu
Condition: Influenza, Human
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Study Design:

      This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and
      immunogenicity of four vaccination regimens against the influenza virus hemagglutinin H5. One
      group will receive A/Indonesia/05/2005 (inactivated H5N1) vaccine as both prime and boost,
      two groups will receive the VRC-AVIDNA036-00-VP (DNA) vaccine as prime with inactivated H5N1
      boost but with different boost intervals, and one group will receive the DNA vaccine twice as
      prime followed by H5N1 boost. The hypothesis is that these regimens will be safe for human
      administration and will elicit antibody and T cell responses against the H5 protein. The
      primary objectives are to evaluate the safety and tolerability of the investigational vaccine
      regimens, at a dose of 4 mg for the DNA vaccine and 90 microgram for the inactivated H5N1, in
      healthy adults. Secondary and exploratory objectives are related to the immunogenicity of the
      study vaccine regimens.

      Product Description:

      The inactivated H5N1 vaccine is monovalent subunit virion vaccine, A/Indonesia/05/2005 clade
      2, manufactured by Sanofi Pasteur, Inc (Swiftwater, PA). Vaccine vials will be supplied at 90
      microgram/0.5mL. The VRC-AVIDNA036-00-VP vaccine was developed and manufactured by VRC, NIAID
      and is composed of a single closed-circular DNA plasmid that encodes the H5 protein with a
      CMV/R promoter. Vaccine vials will be supplied at 4 mg/mL. Each vaccination will be
      administered intramuscularly (IM) in the deltoid muscle using needle and syringe for the H5N1
      vaccine and the Biojector (Trademark) 2000 Needle-Free Injection Management System
      (Biojector) for the DNA vaccine.

      Subjects:

      A total of 60 healthy adults, ages 18-60 years will be enrolled.

      Study Plan:

      Subjects will be simultaneously randomized at a ratio of 1:1:1:1 into one of four groups.
      Subjects and clinicians will be blinded to group assignment until Day 0 following completion
      of the enrollment. At the point of enrollment the randomly assigned regimen will become known
      to subjects and clinicians. Subjects will receive either two or three injections on the
      schedule shown in the schema. The protocol requires five clinic visits and two telephone
      follow-up contacts for Groups 1, 2, and 3, and six clinic visits and three telephone
      follow-up contacts for Group 4.
    

Detailed description: 
      Study Design:

      This is a Phase I, randomized, open-label study to evaluate the safety, tolerability, and
      immunogenicity of four vaccination regimens against the influenza virus hemagglutinin H5. One
      group will receive A/Indonesia/05/2005 (inactivated H5N1) vaccine as both prime and boost,
      two groups will receive the VRC-AVIDNA036-00-VP (DNA) vaccine as prime with inactivated H5N1
      boost but with different boost intervals, and one group will receive the DNA vaccine twice as
      prime followed by H5N1 boost. The hypothesis is that these regimens will be safe for human
      administration and will elicit antibody and T cell responses against the H5 protein. The
      primary objectives are to evaluate the safety and tolerability of the investigational vaccine
      regimens, at a dose of 4 mg for the DNA vaccine and 90 microgram for the inactivated H5N1, in
      healthy adults. Secondary and exploratory objectives are related to the immunogenicity of the
      study vaccine regimens.

      Product Description:

      The inactivated H5N1 vaccine is monovalent subunit virion vaccine, A/Indonesia/05/2005 clade
      2, manufactured by Sanofi Pasteur, Inc (Swiftwater, PA). Vaccine vials will be supplied at 90
      microgram/0.5mL. The VRC-AVIDNA036-00-VP vaccine was developed and manufactured by VRC, NIAID
      and is composed of a single closed-circular DNA plasmid that encodes the H5 protein with a
      CMV/R promoter. Vaccine vials will be supplied at 4 mg/mL. Each vaccination will be
      administered intramuscularly (IM) in the deltoid muscle using needle and syringe for the H5N1
      vaccine and the Biojector (Trademark) 2000 Needle-Free Injection Management System
      (Biojector) for the DNA vaccine.

      Subjects:

      A total of 60 healthy adults, ages 18-60 years will be enrolled.

      Study Plan:

      Subjects will be simultaneously randomized at a ratio of 1:1:1:1 into one of four groups.
      Subjects and clinicians will be blinded to group assignment until Day 0 following completion
      of the enrollment. At the point of enrollment the randomly assigned regimen will become known
      to subjects and clinicians. Subjects will receive either two or three injections on the
      schedule shown in the schema. The protocol requires five clinic visits and two telephone
      follow-up contacts for Groups 1, 2, and 3, and six clinic visits and three telephone
      follow-up contacts for Group 4.
    

Intervention name(s): Monovalent Influenza Subunit Virion (H5N1) Vaccine, A/Indonesia/05/2005; VRC-AViDNA036-00-VP
Intervention type(s): Drug; Drug
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Healthy; Avian Influenza; Immunity; Preventive; Bird Flu; Healthy Volunteer; HV; Influenza