Predictors of Reactogenicity for an AS03-adjuvanted Avian Influenza A (H5N1) Vaccine Open Access

Williams, Sabrina (2017)

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Objectives: To evaluate the determinants of local and systemic reactogenicity following first and second vaccination with an AS03-adjuvanted or non-adjuvanted Influenza A /Indonesia/5/2005 (H5N1) vaccine.

Methods: The data comes from a Phase II clinical trial, Systems Biology of Influenza A (H5N1) Virus Monovalent Vaccine With and Without Adjuvant System 03 (AS03) ( identifier NCT01910519) conducted by Emory University and sponsored by the National Institute of Allergy and Infectious Diseases of the NIH in 2013-2014. The dataset contains data on all 50 study participants with epidemiological information collected at baseline, and clinical and immunological data collected on Days 0, 21(±3), 42 (±3) and 100 (±14). Frequency and proportion of individual reactogenicity events were compared across the AS03-adjuvanted and non-adjuvanted groups. Due to significant multicollinearity among the predictors and small sample size, associations between predictors and both local and systemic reactogenicity could not be determined.

Results: Descriptive data suggests a strong association between H5N1 vaccination with the AS03 adjuvant and the local reactogenicity events, pain and swelling.

Conclusions: Data from this clinical trial empirically support reactogenicity trends from other clinical trial data, however, conclusions cannot be drawn from these analyses. Further research is needed to understand the relationships between the predictors and reactogenicity outcomes, especially with relation to how an increase in reactogenicity outcomes affect vaccine response and uptake.

Table of Contents

Introduction 1

Methods 2

Study Design and Participants 2

Study Products 3

Data Source 3

Study Variable Measurements 4

Data Analysis 4

Ethics 5

Results 6

Study Subjects 6

Antibody Responses 6

Logistic Regression 7

Discussion 9

Strength and Limitations 10

Conclusions 11

References 12

Tables and Figures 15

Appendices 20

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