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)) .
