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InfluenzaNCT00138398

T-cell Response-Flu Risk in Older Adults

A study testing Commercial TriValent Split Influenza Virus in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 99 yearsHealthy volunteers can take part
Conditions the study is for
Influenza
What is being tested?
Commercial TriValent Split Influenza Virus
How many people
850 participants
Where
1 siteUnited States
Study dates
25 Oct 2005to not given
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 99 years
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Willing to be vaccinated with the current influenza vaccine.
  • Healthy young adults are 20-40 years and have no underlying chronic diseases.
  • 'Healthy' older adult participants are age 60 and older who may have underlying chronic diseases but no diagnosis of CHF, advanced kidney disease or diabetes requiring insulin.
  • High-risk older adults with cardiovascular disease are age 60 years and older and have a diagnosis of CHF, or IHD including ACS in the previous winter season.

Who cannot join

  • Allergic reactions to eggs or preservatives such as those contained in contact lens solutions.
  • A previous significant reaction to vaccination or if they refuse to receive influenza vaccination.
  • Known immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily) or have not received influenza vaccination in the past.
  • Subjects who report respiratory illness within the two-week period prior to vaccination. Subjects reporting respiratory symptoms at the first study visit are re-scheduled to a time when they have not had a respiratory illness (at least two symptoms of cough, runny nose, malaise and fever) within the two-week period prior to vaccination.
  • Cardiovascular diseases due to intravenous drug abuse, myocarditis or congenital abnormalities
  • Any condition that in the opinion of the investigator would interfere with the interpretation or the evaluation of the vaccine

Trial locations and contacts

1 site in 1 country.

United States1 site
  • University of Connecticut Health Center

    Farmington, Connecticut, 06030

Other trials in United States

About this study

Official title: T-cell Responses Predict Influenza Risk in Older Adults

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.

Read the 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 and/or 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 and/or 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.

Conditions
Influenza
Being tested
Commercial TriValent Split Influenza Virus
Keywords
Influenza, T cell, vaccine, Congestive heart failure
Medical subject headings
Influenza, Human, Heart Failure

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Commercial TriValent Split Influenza VirusBiological

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted30 Aug 2005 (estimated)
  2. Study start25 Oct 2005

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Prevention
Allocation
Non-randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
850 participants
IDs, dates and publications
ClinicalTrials.gov ID
NCT00138398
Sponsor's protocol ID
05-0056
Status last verified
Feb 2013
First submitted
26 Aug 2005
Last updated
15 Feb 2019
Results posted
No

Questions about this trial

What is this clinical trial studying?

A study testing Commercial TriValent Split Influenza Virus in people with Influenza, run by National Institute of Allergy and Infectious Diseases (NIAID) at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 15 Feb 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2019.

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