Inactivated Influenza Vaccine Delivered by Microneedle Patch or by Hypodermic Needle
Condition: Influenza
MeSH terms: Influenza, Human
Study type: Interventional
Phase: Phase 1

Summary: 
      Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of
      Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle.

      This is a single center, partially blinded, randomized phase I study in which healthy adult
      subjects (ages 18-49) will receive either inactivated influenza vaccine (IIV) (either by
      microneedle patch or hypodermic needle) or placebo (by microneedle patch). This study is
      designed to investigate the safety, reactogenicity, acceptability and immunogenicity of an
      inactivated influenza vaccine delivered by microneedle patch.
    

Detailed description: 
      Title: A Phase I Study of The Safety, Reactogenicity, Acceptability and Immunogenicity of
      Inactivated Influenza Vaccine Delivered either by Microneedle Patch or by Hypodermic Needle.

      Population: healthy adults, 18-49 years inclusive

      Number of Sites: One

      Study Duration: 12 months

      Subject Duration: 6 months

      Objectives:

      Primary:

      To evaluate the safety and reactogenicity following receipt of inactivated influenza vaccine
      delivered by microneedle patch (either by staff or self-administered).

      Secondary:

      To evaluate the HAI titers following receipt of inactivated influenza vaccine delivered
      either by microneedle patch or by hypodermic needle (both vaccines administered by study
      staff).

      To evaluate unsolicited adverse events following receipt of IIV delivered by microneedle
      patch (administered by study staff or self-administered).

      To evaluate new-onset chronic illnesses (NOCI) following receipt of IIV delivered by
      microneedle patch (administered by study staff or self-administered).

      Exploratory:

      To evaluate microneutralizing antibody titers following receipt of inactivated influenza
      vaccine delivered either by microneedle patch or by hypodermic needle (both vaccines
      administered by study staff).

      To evaluate HAI +/- microneutralization and ELISA titers following receipt of inactivated
      influenza vaccine delivered by microneedle patch (administered by study staff or self-
      administered) and compare to inactivated influenza vaccine delivered by hypodermic needle
      (administered by study staff).

      To evaluate HAI +/- microneutralization and ELISA titers following receipt of inactivated
      influenza vaccine delivered by microneedle patch (administered by study staff) and compare to
      inactivated Influenza vaccine delivered by microneedle patch (self-administered).

      To evaluate T follicular helper cells following receipt of inactivated influenza vaccine
      delivered by microneedle patch (administered by study staff or self-administered) and compare
      to inactivated influenza vaccine delivered by hypodermic needle (administered by study
      staff).

      To evaluate innate immunity signatures by microarrays following receipt of inactivated
      influenza vaccine delivered by microneedle patch (administered by study staff or
      self-administered) and compare to inactivated influenza vaccine delivered by hypodermic
      needle (administered by study staff).

      To evaluate B memory cells, CD4 and CD8 central memory and effector T cells, intracellular
      cytokine staining (ICS) for interferon-gamma and interleukin-4, cross reactive T cells
      following receipt of inactivated influenza vaccine delivered by microneedle patch
      (administered by study staff or self- administered) and compare to inactivated influenza
      vaccine delivered by hypodermic needle (administered by study staff).

      To evaluate the acceptability of inactivated Influenza vaccine delivered by microneedle patch
      (administered by study staff or self-administered) and compare to inactivated influenza
      vaccine delivered by hypodermic needle (administered by study staff).

      Schematic of Study Design:

      This is a single center, partially blinded, randomized phase I study in which healthy adult
      subjects (ages 18-49) will receive either inactivated influenza vaccine (IIV) (either by
      microneedle patch or hypodermic needle) or placebo (by microneedle patch). This study is
      designed to investigate the safety, reactogenicity, acceptability and immunogenicity of an
      inactivated influenza vaccine delivered by microneedle patch.

      A total of 100 subjects (25 subjects in each group) will be randomized to one of four groups
      as in the schematic of the study design below.

      Group A: Inactivated influenza vaccine delivered by microneedle patch administered by study
      staff Group B: Inactivated influenza vaccine delivered by intramuscular injection
      administered by study staff Group C: Inactivated influenza vaccine delivered by microneedle
      patch administered by subject Group D: Placebo delivered by microneedle patch and
      administered by study staff

      Each subject will have 6 clinic visits: D0, D2 (+1 day), D8 (+2 days), D28 (+/- 2 days), D56
      (+/- 5 days), and D180( +/- 14 days).

      Blood draws will be obtained at 6 clinic visits to evaluate for immunogenicity (D0, D2 (+1
      day) D8 (+ 2 days) - D28 (+/- 2 days), D56 (+/- 5 days), and D180 (+/- 14 days)) and at four
      clinic visits for safety (D0, D2 (+1 day), D8 (+2 days), and D28 (+/- 2 days)).

      Safety will be measured by the occurrence of solicited injection site and systemic
      reactogenicity on the day of study product administration through 7 days after, and serious
      adverse events (SAEs) and new-onset chronic medical conditions through 180 days after study
      product administration.

      Immunogenicity testing will include performing hemagglutination inhibition (HAI) +/-
      microneutralizing antibody assays as well as other adaptive immune assays on D0 prior to
      study product administration and at D8 (+2 days) , D28 (+/- 2 days), D56 (+/-5 days), and
      D180 (+/-14 days)) .
    

Intervention name(s): Inactivated influenza vaccine; Placebo
Intervention type(s): Biological; Other
Intervention description(s): Seasonal trivalent inactivated influenza vaccine FDA-approved for 2014-2015 influenza season
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Investigator)
Primary purpose: Prevention