Seasonal Influenza HA DNA With Trivalent Inactivated Vaccine (TIV) Administered ID or IM in Healthy Adults 18-70 Years
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase Ib study in healthy adults (18-70 years) to evaluate the safety,
      tolerability, and immunogenicity of same season and sequential season vaccination schedules
      consisting of the 2012/2013 seasonal influenza DNA vaccine (HA DNA) and licensed trivalent
      influenza vaccine (TIV) administered intradermally (ID) or intramuscularly (IM). The
      hypothesis is that evaluation of these investigational schedules will inform development of
      novel influenza vaccine strategies that may offer improved and cross-protective immunity
      against antigenically diverse influenza strains.
    

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 propose to use DNA vaccine antigen delivery to induce immune responses
      against native hemagglutinin (HA) structures prior to boosting with licensed TIV ID or with
      TIV IM.

      The study will allow evaluation of the safety and immunogenicity of same season and
      sequential season vaccination schedules. The same season regimens (2012/13 prime and boost
      with a 14 week interval) consist of HA DNA prime with TIV ID boost -- or -- HA DNA prime with
      TIV IM boost. The active comparator for these schedules are TIV ID or TIV IM alone because a
      single dose of TIV is the standard for adult influenza vaccination within a single season.
      The sequential season regimens (2012/13 prime and 2013/14 boost) consist of concurrent
      administration (in different arms) of HA DNA and TIV ID prime with TIV ID boost -- or -- HA
      DNA and TIV IM prime with TIV IM boost. The active comparator for these regimens will be TIV
      ID followed by TIV ID boost -- or -- TIV IM followed by TIV IM boost, administered sequential
      seasons consistent with as typical pattern of use for these licensed vaccines. Evaluation of
      the investigational schedules and active comparator schedules will inform development of
      novel influenza vaccine strategies that may offer improved and cross-protective immunity
      against diverse influenza strains.
    

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 4 mg dosage is administered as a 1 mL volume.; 2012/13, 2013/14 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 TIV (Fluzone); 2013/14 Seasonal Influenza TIV (Fluzone)
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 Adults; Intradermal (ID)