- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00798343
Heterosubtypic Immune Responses to Influenza in Older People
Evaluation of Heterosubtypic Immune Responses in Older People Before and After Seasonal and Pandemic Influenza Vaccination
Vaccination is the principal means of combating epidemic and pandemic influenza. As vaccines induce relatively strain-specific and short-lived antibody responses, annual immunisation with regularly updated vaccine is recommended for seasonal influenza, but would not be expected to protect against a pandemic event. In clinical trials among young adults, at least two doses of avian influenza H5 or H9 subunit vaccine are needed to induce moderate antibody responses. However, studies including older subjects have unexpectedly found that some people aged over 65 yrs have pre-vaccination neutralising antibody to influenza H5 and H9 respectively. These subjects mount a robust antibody response to single dose H5 or H9 pandemic vaccine, suggesting that they are effectively primed to at least some strains of avian influenza.
This exploratory proposal focuses on those elderly subjects whose immune systems already exhibit antibodies to H5 with a goal of investigating the humoral and cellular basis of the immune response to seasonal and pandemic vaccination. We will examine neutralising antibody responses to a range of human and non-human influenza viruses before and after seasonal and pandemic vaccination and evaluate cellular B and T cell immune responses before and after pandemic H5 vaccination
연구 개요
상세 설명
STUDY OBJECTIVES:
Immunological objectives
- To evaluate heterosubtypic neutralising antibody to influenza viruses in older people
- To evaluate heterosubtypic neutralising antibody responses to human and non-human influenza viruses following seasonal influenza vaccine
- To evaluate homologous and heterosubtypic neutralising antibody responses to human and non-human influenza viruses after MF59-adjuvanted H5N1 vaccine;
- To evaluate cellular B and T cell responses to influenza H5 in non-exposed subjects who exhibit anti-H5 neutralising antibodies before and after seasonal (TIV) or pandemic H5 vaccination
- To identify epitopes on the influenza haemagglutinin to which anti-H5 neutralising antibodies in sera from non-exposed subjects are directed Safety Objectives
- To evaluate safety of one or two IM doses of MF59-adjuvanted A/Vietnam/1194/2004 (H5N1) influenza vaccine, containing 7.5 μg of H5 antigen in adult subjects
- To evaluate safety of one IM dose of seasonal influenza vaccine, containing 15 μg of H1, H3 and B antigen in adult subjects
Hypotheses:
- Heterosubtypic cross reacting antibodies to influenza exist in some elderly subjects and can be boosted by a single dose of (a) seasonal TIV or (b) pandemic influenza vaccination
- Heterosubtypic cross reacting antibodies to influenza do not exist in younger subjects and cannot be induced by (a) seasonal TIV or (b) pandemic influenza vaccination
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Leicestershire
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Leicester, Leicestershire, 영국, LE1 5WW
- University Hospitals Leicester
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Subjects aged over 18 years of age, mentally competent, who have signed an informed consent form after having received a detailed explanation of the study protocol;
- Subjects willing to be enrolled in the vaccine study if appropriate from prescreening blood test results
In good health as determined by:
- medical history,
- physical examination,
- clinical judgment of the Investigator;
- Able to understand and comply with all study procedures and to complete study diaries, can be contacted, and will be available for study visits
Exclusion Criteria:
- Receipt of another investigational agent within 4 weeks, or before completion of the safety follow-up period in another study, whichever is longer, prior to enrollment and unwilling to refuse participation in another clinical study through the end of the study;
- Subjects who experienced any acute disease or infection requiring systemic antibiotic or antiviral therapy (chronic antibiotic therapy for urinary tract prophylaxis is acceptable) within the past 7 days before Visit 1 or any visit where trial vaccination is planned;
- Subjects who experienced fever (within 3 days prior to Visit 1;
- Subjects who are pregnant or breastfeeding;
- Females of childbearing potential who refuse to use an acceptable method of birth control for the duration of the study.
Subjects with any serious disease, such as:
- cancer,
- autoimmune disease (including rheumatoid arthritis),
- progressive chronic pulmonary disease (stable controlled respiratory disease including asthma is allowed),
- acute or progressive hepatic disease,
- acute or progressive renal disease;
- Subjects for whom elective surgery is planned during the study period;
- Subjects with bleeding diathesis;
- Subjects with hypersensitivity to eggs, chicken protein, chicken feathers, influenza viral protein, neomycin or polymyxin or any other component of the study vaccine;
- Subjects with a history of any neurological symptoms or signs, or anaphylactic shock following administration of any vaccine;
Subjects with known or suspected impairment/alteration of immune function, for example, resulting from:
- receipt of immunosuppressive therapy (any corticosteroid therapy or cancer chemotherapy),
- receipt of immunostimulants,
- receipt of parenteral immunoglobulin preparation, blood products, and/or plasma derivatives within 3 months prior to Visit 1 or planned during the full length of the study,
- high risk for developing an immunocompromising disease;
- Receipt of another vaccine within 3 weeks prior to Visit 1 or planned vaccination within 3 weeks following the last study vaccination;
- Subjects with a history of (or current) drug or alcohol abuse that in the investigator's opinion would interfere with safety of the subject or the evaluation of study objectives;
Subjects with any condition, which, in the opinion of the Investigator, might interfere with the evaluation of the study objectives.
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공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 기초 과학
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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활성 비교기: Seasonal vaccine
Seasonal influenza vaccination
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Non-adjuvanted seasonal influenza vaccine (total dose 45ug)
다른 이름들:
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실험적: Pandemic vaccine
MF59-adjuvanted H5N1 monovalent vaccine
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MF59-adjuvanted A/Vietnam/1194 H5N1 vaccine 7.5ug dose
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Neutralising antibody to influenza subtypes
기간: 18 months
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18 months
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2차 결과 측정
결과 측정 |
기간 |
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Reactogenicity (local and systemic) to H5N1 vaccine
기간: 18 months
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18 months
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공동 작업자 및 조사자
수사관
- 수석 연구원: Iain Stephenson, FRCP, University of Leicester
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- UHL10548
- MRC 82292
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