- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT03161366
Providing Additional Information on the Safety and Effectiveness of an Ebola Vaccine
An Open-label, Single Arm Study to Provide Additional Information on Safety and Effectiveness of rVSVΔG-ZEBOV-GP
연구 개요
상세 설명
Ebola Virus Disease remains ill-known by populations, creating fear and mistrust, is highly contagious, requiring strict isolation measures and with only supportive therapy available that has limited impact on case-fatality which remains high (30 -80%).1 Among vaccines in development, the rVSVΔG-ZEBOV-GP vaccine has given the most promising results in terms of efficacy and safety having been evaluated now in more than 10,000 individuals.
Ring vaccination is a known strategy to control epidemics with specific transmission chains and has been successfully implemented to eradicate smallpox. Ring vaccination enhances standard public health measures of contact tracing, isolation, and community engagement and could be effective when such measures are in place. Building on the interim results of the Ebola ça Suffit trial, there is a need for continued access to a vaccine of which available results suggest that it is safe and likely efficacious against EVD. Although only isolated cases have been reported in Guinea, Sierra Leone and Liberia in 2016, 10 the risk of resurgence or of continued isolated cases in West Africa remains. Moreover, a new outbreak with Ebola Zaïre could start any moment in any of the countries where previous outbreaks occurred as in for example Democratic Republic of Congo and Uganda.
However, the unusual design of the ring trial and the decision to abandon the control group because of strong evidence that the vaccine prevented disease means there may not be enough data to ensure approval from regulatory agencies. Therefore, additional information is still required to consolidate knowledge on the rVSVΔG-ZEBOV-GP vaccine to support regulatory approval and licensure for future access. Additional information is also needed on ring vaccination and contextual adaptations to this approach to ensure its feasibility and effectiveness in the control of Ebola outbreaks in potentially diverse contexts.
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Individuals aged 6 years or older will be enrolled in the study if they are a contact or contact of contact of a laboratory-confirmed Ebola virus disease case. Children aged between 1 and 6 years may also be enrolled in the study in case there is a confirmed contact with a laboratory-confirmed Ebola patient
- willing to accept weekly visits
- intending to remain in the study area for three months
- providing informed consent, and where applicable, assent
Exclusion Criteria:
- history of EVD (self-report or laboratory confirmed)
- history of having received other investigational research agents in the previous 28 days
- history of anaphylaxis to a vaccine or vaccine component (self-report)
- severe illness that makes the person bed-bound or requiring hospitalization at the time of the vaccination
- severe immunocompromised status
- history of having received immunosuppressant therapies that would substantially interfere with the mode of action of the Ebola vaccine in the previous 6 months
- unwilling to accept weekly visits
- not intending to remain in the study area for three months
- informed consent or assent not provided
- any other condition in which, in the judgment of the investigator, would interfere with or serve as a contraindication to protocol adherence, or impair the subject or caregiver's ability to give informed consent, and where applicable, assent.
- fever above 38°C
- previous receipt of rVSVΔG-ZEBOV-GP in the last 3 years or at being part of another Ebola vaccine clinical trial.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 방지
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: Single arm
Vaccination of contacts and contacts of contacts of a confirmed Ebola Zaire case with one dose of rVSVΔG-ZEBOV-GP (≥ 2x10^7 PFU)
|
Ring vaccination with vaccination of contacts and contacts of contacts after laboratory confirmation of one Ebola Zaire case
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Cumulative incidence
기간: 84 days after vaccination
|
Occurrence of Ebola Zaire cases amongst contacts and contacts of contacts
|
84 days after vaccination
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Assessment of Adverse and Serious Adverse Events
기간: 84 days after vaccination
|
Safety of a single dose of rVSVΔG-ZEBOV-GP
|
84 days after vaccination
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
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
- V920-01
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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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rVSVΔG-ZEBOV-GP에 대한 임상 시험
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Centers for Disease Control and PreventionDepartment of Health and Human Services; University of Sierra Leone; Ministry of Health and... 그리고 다른 협력자들완전한
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National Institute of Allergy and Infectious Diseases...London School of Hygiene and Tropical Medicine; Institut National de la Santé Et de la... 그리고 다른 협력자들완전한
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Universitätsklinikum Hamburg-EppendorfUniversity Hospital, Geneva; Wellcome Trust; KEMRI-Wellcome Trust Collaborative Research... 그리고 다른 협력자들완전한
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National Institute of Allergy and Infectious Diseases...완전한
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Canadian Immunization Research NetworkMerck Sharp & Dohme LLC; University of Ottawa; Dalhousie University; Université de Montréal; Centre... 그리고 다른 협력자들완전한
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Universitätsklinikum Hamburg-EppendorfGoethe University; German Federal Ministry of Education and Research; Bernhard Nocht Institute... 그리고 다른 협력자들빼는
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Emory UniversityWashington University School of Medicine; Merck Sharp & Dohme LLC모집하지 않고 적극적으로
-
Centre de Recherche Médicale de LambarénéMerck Sharp & Dohme LLC완전한
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