Protection From Influenza: Determining the Impact of Prior Infection
연구 개요
상세 설명
Significance: This study will provide critical information on the best technique in vaccine candidate testing and improve influenza treatment approaches. The long-term goal of this research is to identify the T-cell responses that are surrogates (biomarkers) of serious complications of influenza in older adults and predict vaccine efficacy (prevention of influenza illness) and vaccine effectiveness (prevention of serious complications). Further, translating new insights into age-related immune dysfunction to the design of new influenza vaccines is critical to addressing this unmet need in the population aged 65 and older.
Innovation: The study will help in the validation of clinical tools and biomarkers as prognostic indicators of influenza illness severity in vaccinated older adults, point-of-care diagnostics that would direct other preventive strategies to reduce the impact of influenza illness in vaccinated older adults, and correlates of protection to evaluate the potential of new influenza vaccines to enhance protection against the serious complications of influenza illness. The investigators have established that GrzB activity and the IFNg: IL-10 ratio in influenza-stimulated PBMC correlate with protection against influenza, and preliminary data to show that low GrzB activity in influenza-stimulated PBMC correlates with more severe disease and higher levels of frailty. The innovations of this project are the established methods for developing correlates of protection, the clinical insights into how frailty affects immune-mediated protection against influenza, and the direct translation of this research to provide a reasonable method for primary care clinicians to estimate vaccine effectiveness in an individual older person. These results will translate to the practical design of clinical trials to evaluate the potential for new influenza vaccines to better protect against the serious complications of influenza and complement those based on antibody titers and/or clinical outcomes alone.
연구 유형
등록 (예상)
연락처 및 위치
연구 연락처
- 이름: Amanda Axler, BSc.
- 전화번호: 1924 7055237300
- 이메일: aaxler@hsnri.ca
연구 장소
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Ontario
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Sudbury, Ontario, 캐나다, P3E 5J1
- 모병
- Health Sciences North Research Institute
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연락하다:
- Amanda l Axler, BSc
- 전화번호: 1924 705-523-7300
- 이메일: aaxler@amric.ca
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연락하다:
- Beth Gentleman, BSc
- 전화번호: 2631 705-523-7300
- 이메일: bgentleman@amric.ca
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수석 연구원:
- Janet E McElhaney, MD
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Written informed consent provided by the participant.
Age 65 years of age or older admitted to Health Sciences North with at least one the following:
- Laboratory confirmed influenza illness
- Acute exacerbation of chronic obstructive pulmonary disease (AECOPD).
- Any respiratory or influenza-like symptoms (dyspnea, cough, sore throat, myalgia, arthralgia, fever, delirium/altered level of consciousness) that a test for influenza was negative.
- Willing to receive influenza vaccination in the subsequent flu season
Exclusion Criteria:
- Patients whose reason for hospital admission was unrelated to influenza or (for example patients admitted due to trauma, elective surgery, or patients who have an alternative diagnosis that is clearly not respiratory).
- Chest x-ray positive for pneumonia.
- Study participants who cannot be vaccinated due to previous severe reaction to influenza vaccine, egg, latex, or thimerosol allergies, or refusal of vaccination.
- Immunosuppressive disorders or medications (including oral prednisone in doses >10 mg daily).
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
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Case
older adult patients (over the age of 65) admitted to Health Sciences North with laboratory confirmed influenza illness (LCII)
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Control
matched control subjects (non-LCII)
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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High expression of CTL associated cytokines and granzymes in PBMC's are predictors of influenza infection severity.
기간: 2 years
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PBMCs from adults hospitalized for laboratory confirmed influenza illness (LCII) will be collected at admission and 30 days post hospitalization.
These samples will be matched with hospitalized non-LCII adult controls.
T-cells will be isolated from whole blood samples and gene expression of IFNg, IL10 and GrzB will be measured and compared between time points and subjects.
These levels do not have a separate unit of measure.
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2 years
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Vaccination in previously infected individuals increases the protection provided by subsequent vaccination and will be higher than those receiving vaccination alone (with no previous infection)
기간: 2 years
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Older adults hospitalized for influenza illness the previous season will be compared to matched, hospitalized older adults with influenza-like illness (non-LCII).
PBMCs will be collected from each group, before receiving influenza vaccination and 4 weeks after vaccination.
PBMCs will be challenged ex vivo with influenza virus and gene expression of CTL related genes will be measured and compared between each group.
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2 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (예상)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- Protection from Influenza
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
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