- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01922648
RSV Observational Study 2
Analysis of the Immune Response to Respiratory Syncytial Virus (RSV) Exposure in a Paediatric Population
Respiratory Syncytial Virus (RSV) is a virus that causes chest infections. It is the single most important cause of severe respiratory illness in infants and young children, and severe RSV infection early in life is associated with an increased risk of later developing asthma. RSV also causes severe disease in elderly and immune-compromised adults, and the amount of RSV disease in the elderly is similar to that from seasonal flu. The virus is transmitted in the secretions of the upper respiratory tract of infected individuals and by contact with contaminated surfaces (such as toys). Hospital outbreaks, especially on paediatric and neonatal wards, are not uncommon.
Infection by RSV does not develop a natural long-lasting protection against re-infection (like, for example, measles does). In the USA nearly all children by 24 months of age have been infected at least once with RSV, and about half will have experienced two infections. There is no effective anti-viral drug to treat an infection and the only way of managing cases of severe infection is through supporting organs, such as the lungs, to withstand and recover from the illness.
There remains a real need to develop an effective vaccine to prevent severe infections caused by RSV. A better understanding of the way the immune system responds to RSV in children would aid the development of such a vaccine.
The purpose of this study is to increase our understanding of how the immune system responds to RSV. Only limited data is available on some important components of the immune response and this study is designed to measure these in more detail. This is done using a single blood sample.
A total of 35 children are anticipated to be recruited to this study, at ages when we expect to see differences in the immune response to RSV;
- 5 infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV
- 20 infants aged between 6 and 12 months (Group 2), who will have had exposure to one single RSV season in the winter of 2011/12
- 10 children aged between 3 and 6 years (Group 3), who have been exposed to RSV over several winter seasons
연구 개요
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Oxford, 영국, OX3 9DU
- Oxford University Hopsitals NHS Trust
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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:
- Parent or guardian is willing and able to give informed consent for participation in the study
- Age suitable for Group 1, 2 or 3 as defined in above (Section 6.2)
- Delivery at 36 weeks gestation or later
- Having a blood sample for clinical reasons
Exclusion Criteria:
- Parent or guardian unable or unwilling to give informed consent for participation in the study
- Any impaired function of the immune system, by medication or pathological process, which could augment or impair the immune response to RSV
- Concurrent acute or chronic infection
- Any chronic illness which, in the opinion of the Investigator, may lead to incorrect or inaccurate immunology data
- History of immunoprophylaxis with Palivizumab
- Delivery prior to 36 weeks gestation
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
---|---|
2-4 months
Infants aged between 2 and 4 months (Group 1), who have not yet been exposed to RSV
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An extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason.
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6 - 12 months
Infants aged between 6 and 12 months (Group 2), who will have had exposure to one single RSV season in the winter of 2011/12
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An extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason.
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3 - 6 years
Children aged between 3 and 6 years (Group 3), who have been exposed to RSV over several winter seasons
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An extra volume of blood is obtained, with prior consent, when phlebotomy is required for another unrelated clinical reason.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
---|---|---|
To assess the induction of RSV-specific immune responses in blood following natural exposure
기간: one year
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The following assays characterise the primary objective:
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one year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Andrew J Pollard, University of Oxford
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
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
- 2013/01
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. .
Blood sample에 대한 임상 시험
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Haydarpasa Numune Training and Research Hospital완전한
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University Hospital, Rouen아직 모집하지 않음
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Ischemia Care LLC완전한허혈성 뇌졸중 | 심방세동 | 혈전성 뇌졸중 | 일시적인 허혈 발작 | 심장색전성 뇌졸중 | 뇌저동맥의 뇌졸중 | 일시적인 뇌혈관 사건미국
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Applied Science & Performance Institute완전한