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Clinical Trial Details
Immune Response to High-Dose vs. Standard Dose Influenza Vaccine
Clinical Trial ( IRB ) #: 15-006-3
Title: Immune Response to High-Dose vs. Standard Dose Influenza Vaccine
Principal Investigator: Dr. George Kuchel
Description: This is a 5-year randomized study of split-virus influenza vaccine (SVV) in a high-dose (HD) vs. standard dose (SD) formulation in each of five influenza seasons to define the key determinants of vaccine-mediated protection against influenza and how these immunologic mediators may be enhanced by vaccination with a U.S. approved high-dose influenza vaccine in older people. Trial Objectives The strategic objectives of this proposal are to conduct a randomized study of the U.S. approved SD-SVV vs. HD-SVV to establish GrzB activity and the IFN :IL-10 ratio in influenza-stimulated PBMC as biomarkers of clinical protection against the serious complications of influenza infection; develop a clinical tool (frailty index) and biomarkers (CMV status and bGrzB activity) for use in point-of-care testing to predict the response to influenza vaccination and appropriately target other prevention strategies to reduce the impact of influenza illness in particularly vulnerable older people; and translate these findings to testing new vaccines for their potential to significantly enhance protection against the serious complications of influenza in older adults. In the process, we will determine whether the Frailty Index [31], as a predictor of functional decline and mortality [32], can be used as point-of-care testing in the management of influenza. Table 1 summarizes the 5-year plan. The experimental design incorporates extensive experience in measuring T-cell responses to influenza vaccination and a study design that reflects an understanding of the variables that contribute to the heterogeneity of health and frailty in older adults. The overall experimental plan is described in three sections including a) Study Populations, b) Experimental Design including the Overall study protocol and Specific Aims 1-3), and c) Tests and Assays. Study Hypothesis (Aim 1) Determine whether a high dose vaccine performs better than standard doses Study Hypothesis (Aim 2): Evaluate the association of degree of frailty to cytomegalovirus (CMV) status and bGrzB levels in resting T cells. Study Hypothesis (Aim 3): Establish predictors of vaccine-mediated protection that can be developed for point-of-care testing
  Infectious Disease/Immune System (HIV/AIDS, Hepatitis)
Eligibility Criteria: Check with study contact
How to Contact: Lisa Kenyon-Pesce. Telephone: (860) 679-2305. Email: Kenyon-Pesce@uchc.edu
Enrollment Status/Comments: Enrolling/recruiting. For current recruitment status, please check with study contact.
Web Address: clinicaltrials.gov/ct2/show/NCT02297542?term=Immune+Response+to+High-Dose+vs.+Standard+Dose+Influenza+Vaccine&rank=1