Seasonal Influenza DNA Vaccine Prime With Trivalent Inactivated Vaccine (TIV) Boost Compared to TIV Alone
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      This is a Phase 1b, randomized study in healthy younger (18-50 years) and older (51-70 years)
      adults to evaluate the safety, tolerability, and immunogenicity of a prime-boost vaccination
      regimen with an investigational plasmid DNA vaccine directed towards the 2011/12 influenza
      vaccine strains as a prime followed 36 weeks later by the 2012/13 influenza trivalent
      inactivated vaccine (TIV) as the booster injection, as compared to placebo prime followed by
      the 2012/13 seasonal TIV. The hypothesis is that the DNA vaccine will be safe for human
      administration and that the DNA vaccine prime-TIV boost schedule will elicit a better immune
      response than the seasonal TIV alone.
    

Detailed description: 
      Vaccines are an effective way of preventing influenza infection and transmission in humans.
      Although licensed influenza vaccines are available, ways to improve influenza vaccines
      continue to be studied. Annually, the World Health Organization (WHO) and the U.S FDA make
      recommendations on the composition of the seasonal influenza vaccine, with recommendations
      for the Northern Hemisphere (NH) and for the Southern Hemisphere (SH) considered at different
      times based on epidemiology data. The annually licensed influenza vaccines consist of 3
      components: an Influenza A (H1N1) strain, an Influenza A (H3N2) strain, and an influenza B
      strain. The current U.S. FDA-licensed influenza vaccines depend upon labor-intensive methods
      that limit manufacturing capacity and which do not induce broad immune responses to various
      strains of influenza. The vaccine composition requires frequent adjustment for emerging
      influenza strains.

      The need for influenza vaccines that are more immunogenic and able to induce a more universal
      immune response against a broad spectrum of influenza strains is well recognized. Earlier
      laboratory and clinical studies together suggest that an investigational DNA vaccine encoding
      for the influenza hemagglutinin protein(HA DNA vaccine) administered as a prime, followed by
      a boost with a traditional inactivated influenza vaccine, may induce a stronger immune
      response against various influenza strains and with improved durability. The interval of time
      between the prime vaccination and the boost vaccination is important for the strength of the
      immune response.

      This clinical trial will evaluate the safety, tolerability and immune responses to the
      investigational HA DNA vaccine prime-TIV boost schedule compared to a placebo prime-TIV boost
      schedule when the time between the prime and boost is 36 weeks.
    

Intervention name(s): DNA vaccine; TIV
Intervention type(s): Biological; Biological
Intervention description(s): VRC-FLUDNA061-00-VP is composed of 3 closed-circular DNA plasmids that encode for the hemagglutinin (HA) from the following 3 strains: A/California/04/2009 (H1N1); A/Perth/16/2009 (H3N2), and B/Brisbane/60/2008. DNA vaccine vials will be supplied at 4 mg/mL and each dose will be 1 mL.; 2012/13 Seasonal Influenza Trivalent Inactivated Vaccine (TIV)
Other intervention name(s): VRC-FLUDNA061-00-VP; HA DNA Vaccine; Seasonal influenza trivalent DNA vaccine; Trivalent Inactivated Vaccine
Intervention MeSH terms: Vaccines
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary purpose: Prevention
Keywords: Influenza A (H1N1); Influenza A (H3N2); Influenza B; Trivalent Inactivated Vaccine (TIV); Healthy Adults