Predictors of Reactogenicity to Influenza Vaccination by Microneedle Patch or Hypodermic Needle Open Access

Paine, Michele Bennett (2016)

Permanent URL: https://etd.library.emory.edu/concern/etds/3r074v69c?locale=en
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Abstract

Objectives : To evaluate the determinants of local and systemic reactogenicity after hypodermic needle insertion or microneedle patch application containing inactivated influenza vaccine (IIV) or placebo. Methods: The dataset comes from a phase 1 clinical trial from the Microneedle Patch study TIV-MNP2015 (Clinicaltrials.gov identifier NCT02438423) conducted by Emory University and sponsored by NIH and Georgia Institute of Technology in 2015-2016. The dataset contains data on 100 study participants with epidemiological information collected at baseline and clinical and immunological data collected on Days 0, 2 (+1), 8 (+2), 28 (+/-2), 56 (+/-5), and 180 (+/-14) post vaccination. We used regression analysis to examine the effects of variables such as age, sex, BMI, race, ethnicity, prior influenza vaccination, and immunogenicity on reactogenicity. Results: Variables such as age and antibody titers measured by geometric mean titers (GMT) at day 28 post vaccination were shown to be associated with local reactogenicity. Factors that were associated with systemic reactogenicity included age, race, prior receipt of a seasonal influenza vaccination, and GMT at day 28. Conclusions: Personal, demographic, and immunologic factors can affect reactogenicity after vaccination with microneedle patches. These factors merit further investigation and confirmation with other clinical trial data, as better understanding of reactogenicity has implications for acceptance of new technology like microneedle patches and for vaccination acceptance in general.

Table of Contents

Chapter I

Background………………………………………………………………………………………………………...…1

Vaccine delivery and microneedles…………………….…………………………………………………2

Chapter II

Abstract…………………………………………………………………………………………….…………………..6

Introduction…………………………………………………………………………………….…………………...7

Methods…………………………………………………………………………………….………………………....8

Data Source…………………………………………………………………………………….…………………..11

Study Variable Measurements…………………………………………………………………………….11

Data Analysis…………………………………………………………………………………….………………..12

Ethics…………………………………………………………………………………….…………………………....13

Results………………………………………………...………………………………………….………………….13

Discussion…………………………………………………………………………………….……………………..16

Strengths and Limitations……………………………………………………………..…………………..17

Conclusions…………………………………………………………………………………….…………………..18

Tables and Figures…………………………………………………………………………………….………..20

Chapter III

Summary…………………………………………………………………………………….……………………...25

Public Health Implications……………………………………………………………………………………26

Possible Future Directions……………………………………………………………………………………26

References.............................................................................................28

Appendices.............................................................................................30

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