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.
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
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.
- First posted30 Aug 2005 (estimated)
- Study start25 Oct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by National Institute of Allergy and Infectious Diseases (NIAID)The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
Sponsor and investigators
- Sponsor type
- US National Institutes of Health
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
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-cell Responses Predict Influenza Risk in Older Adults
- ClinicalTrials.gov ID
- NCT00138398
- Acronym / sponsor ID
- 05-0056
- Conditions
- Influenza
- Keywords
- Influenza, T cell, vaccine, Congestive heart failure
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 850 participants
- Lead sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)US National Institutes of Health
- Study start
- 25 Oct 2005
- First posted
- 30 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 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.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 20 to 99 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Commercial TriValent Split Influenza Virus | Biological | – |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.