Seasonal Influenza DNA Vaccine & Seasonal Influenza Trivalent Inactivated Vaccine (TIV) in Children & Adolescents
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase I, dose escalation study in healthy adolescents and children (6-17 years) to
      evaluate the safety, tolerability, and immunogenicity of a prime-boost regimen of the
      2012/2013 seasonal influenza DNA vaccine (HA DNA) followed by licensed 2012/2013 TIV vaccine.
      The comparator groups will receive licensed 2012/2013 TIV as prime and boost. The hypothesis
      is that the 2012/2013 HA DNA prime-TIV boost regimen will be safe and result in a broader and
      more durable immune response than is observed in age-matched comparator TIV-TIV groups.
    

Detailed description: 
      Vaccines are an effective way to prevent influenza infection. Each year the World Health
      Organization (WHO) and the U.S FDA recommend the influenza strains to include in the seasonal
      influenza vaccines. The licensed seasonal influenza vaccines are directed against 3 influenza
      virus strains: an influenza A H1N1, an influenza A H3N2, and an influenza B. The currently
      approved vaccines depend upon labor-intensive methods that limit manufacturing speed and
      capacity. Influenza vaccines that can be more rapidly produced and that induce stronger,
      broader and more persistent immune responses are a recognized public health need.

      In this protocol we will evaluate an investigational seasonal influenza (HA DNA) vaccine in
      healthy adolescents and children (6-17 years). Some participants will receive HA DNA vaccine
      "prime" followed by licensed trivalent influenza vaccine (TIV) "boost" 18 weeks later. Other
      participants will receive two TIV injections 18 weeks apart. The results will be compared.
      The HA DNA vaccine and TIV are both directed at the 3 influenza strains selected for the
      2012/2013 vaccines. Prior studies in adults of avian and seasonal influenza DNA vaccines have
      been completed. The DNA vaccinations were assessed as safe and well tolerated in adults. The
      immune response to avian influenza is augmented by DNA vaccine priming compared to two
      vaccinations with the inactivated avian influenza (H5N1)vaccine when the prime-boost interval
      is 12-24 weeks, but not when the prime-boost interval is 4 weeks.
    

Intervention name(s): Seasonal Influenza DNA vaccine; TIV
Intervention type(s): Biological; Biological
Intervention description(s): VRC-FLUDNA063-00-VP is composed of 3 closed-circular DNA plasmids that encode for the hemagglutinin (HA) from the following 3 strains: A/California/04/2009 (H1); A/Victoria/361/2011 (H3), and B/Wisconsin/2010. DNA vaccine vials will be supplied at 4 mg/mL in single use vials. The 1 mg dosage is administered as 0.25 mL volume and the 4 mg dosage as a 1 mL volume.; 2012/13 Seasonal Influenza Trivalent Inactivated Vaccine (TIV)
Other intervention name(s): VRC-FLUDNA063-00-VP; HA DNA Vaccine; Seasonal influenza trivalent DNA vaccine; 2012/13 Seasonal Influenza Trivalent Inactivated Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Prevention
Keywords: Influenza A (H1); Influenza A (H3); Influenza B; DNA Vaccine; Trivalent Inactivated Vaccine (TIV); Healthy Adolescents; Healthy Children