Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00138398
Status:
COMPLETED
Last Update Posted:
2019-02-15
First Post:
2005-08-26
Brief Title:
T-cell Response-Flu Risk in Older Adults
Sponsor:
National Institute of Allergy and Infectious Diseases NIAID
Organization:
National Institute of Allergy and Infectious Diseases NIAID
Study Overview
Official Title:
T-cell Responses Predict Influenza Risk in Older Adults
Status:
COMPLETED
Status Verified Date:
2013-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to determine how the immune system changes with aging and makes influenza a more serious illness in older people Influenza vaccination not only can protect people from getting the flu but also can lessen the severity of the illness This is particularly true for people with congestive heart failure CHF This research may provide information that could eventually lead to a new laboratory test that will predict how effective vaccination is for preventing influenza illness in older people Volunteer participants in this study will include the following groups 1 healthy young adults 20 - 40 years old 2 older adults 60 years and older without a history of CHF 3 older adults 60 years and older with a history of CHF All study participants will be vaccinated with the current preparation of inactivated influenza vaccine A small amount of blood will be drawn before each vaccine and at 4 10 and 16-20 weeks afterward
Detailed Description:
This study will increase the understanding of how age congestive heart failure CHF or a prior hospitalization for an influenza-related acute coronary event affect the immune response to influenza vaccination By elucidating the defects in the immune response to influenza vaccination that are associated with the subsequent influenza illness these methods can be used to screen subsets of older adults to establish the risk profile related to influenza in that population to target these defects for future vaccine development and to use these methods as surrogates of protection to screen potential vaccines prior to conducting large scale clinical trials to establish clinical efficacy The primary objective is to show that granzyme B Grz B levels in influenza virus-stimulated peripheral blood mononuclear cell cultures are lower in older adults who receive inactivated influenza vaccine IIV and subsequently develop influenza illness compared to those who do not Secondary objectives are to 1 establish a cut-off value for Grz B as a marker of increased risk for influenza illness 2 show that interferon-gamma IFN-gamma levels are lower and interleukin-10 IL-10 levels are higher in influenza virus-stimulated peripheral blood mononuclear cell cultures from vaccinated older adults who subsequently develop influenza illness compared to those who do not 3 determine the effect of macrophage migration inhibitory facator MIF on T-cell responses to influenza vaccination 4 determine the association between CHF and ischemic heart disease IHD including acute coronary syndromes and the immune response to influenza vaccination 5 determine the effect of functional status measured by the Six-Minute Walk Test SMWT on immune responsiveness to influenza vaccination 6 determine the effect of medications with anti-inflammatory effects including angiotensin converting enzyme inhibitors ACEI and cholesterol-lowering drugs statins on immune responsiveness to influenza vaccination 7 evaluate the effect of the age-related decline in the expression of the costimulatory molecule CD28 on cytotoxic T-lymphocytes on the Grz B response to influenza vaccination 8 study the potential role of activation-induced cell death AICD on the T helper type 1 Th1 IFN-gamma versus T helper type 2 Th2 IL-10 response to influenza vaccination 9 determine in vitro whether or not co-stimulatory molecules such as 4-1BB ligand or CD70 can be used to augment the cytokine Grz B or CTL responses to influenza vaccines in older adults 10 determine in vitro whether or not heat shock proteins HSP can be used to augment the cytokine andor Grz B response to influenza vaccination in older adults 11 determine in vitro whether or not heat shock proteins HSP can be used to augment the cytokine andor Grz B response to influenza vaccination in older adults who develop influenza illness in spite of influenza vaccination and 12 determine in vitro whether or not heat shock proteins HSP increase the frequency Grz B content or proportion of influenza virus-specific CTL expressing CD28 in vaccinated in older adults The study group will consist of 150 adults age 60 years and older characterized according to age presence of CHF or IHD or to be identified in the prior influenza season an admission with an acute coronary syndrome or exacerbation of CHF All subjects will be vaccinated in the fall of each year with the current preparation of trivalent split-virus influenza vaccine Serum antibody titers serum cytokine levels ex vivo levels of IFN-gamma and IL-10 and ex vivo and in vitro levels of Grz B in influenza-stimulated peripheral blood mononuclear cell at pre-vaccination and post-vaccination 4 10 and 16-20 weeks time points will be compared in subjects who do and do not get influenza illness The peak as well as the duration of response to vaccination for each of the immunologic measures will be determined
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None