Monitoring of the Post-vaccination Immune Response to COVID-19 Among Hospital Staff (COVIDIM)
2021년 5월 21일 업데이트: University Hospital, Clermont-Ferrand
Vaccination against COVID-19 is a major public health issue to control the epidemic and reduce the number of severe infections and deaths. Three vaccines currently received use authorization in France: two mRNA vaccines and one recombinant viral vector vaccine. Immunogenicity data demonstrate that they induce the development of neutralizing antibodies and IgG directed against the viral S1 protein and the receptor binding domain (RBD). However, there are currently no data on the persistence over time of the humoral response induced by vaccination, and data are still incomplete on cellular immunogenicity. No immune correlate of protection has been established for COVID-19.
In addition, these data come from assays carried out with current vaccines developed against a lineage of SARS-CoV-2 known as wild type (without genetic mutations).
The main objective of this study is to monitor in hospital staff the temporal evolution of humoral immunity induced by anti-COVID-19 vaccines by using enzyme-linked immunosorbent assays (ELISA), at 3, 6, 12 and 24 months after the last injection of vaccine.
연구 개요
상세 설명
- All medical, para-medical, medico-technical and administrative staff of the Clermont-Ferrand university hospital will be informed of the protocol through intra-hospital communication. The inclusion visit will be scheduled within 3 months +/- 14 days after the last injection of the vaccine. For volunteers who have not received their first injection, they will be offered to participate in the sub-study including an additional visit on the day of vaccination. They will be free to accept or refuse.
- As recruitment is consecutive, an anonymous list of potentially eligible subjects (with demographic data: age, sex; nature of the vaccine received) will be kept, in order to verify afterwards if the sample is representative.
The study includes:
- Five visits over 21 months, 6 over 24 months for the subgroup included on the day of vaccination
- An interview with an investigator during the first visit, to collect the following data: hospital function, age, sex, weight, height, possible comorbidities exposing to a serious COVID-19 infection, possible COVID-19 infection prior to vaccination, date of vaccination and type of vaccine
- A self-questionnaire to update clinical data if necessary during the following visits
A blood test at each visit, i.e. 2 tubes of 5 mL (antibody assays) and 4 tubes of 1 mL (cellular immunity assay).
Blood samples will be stored at -80°C, before destruction at the end of the study.
- In the case of suspecting symptoms of COVID-19 during follow-up, molecular testing of SARS-CoV-2 infection will be offered and performed from nasopharyngeal swab or saliva sample.
연구 유형
중재적
등록 (예상)
300
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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Aura
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Clermont-Ferrand, Aura, 프랑스, 63000
- 모병
- Clermont-Ferrand University Hospital
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수석 연구원:
- Cécile Henquell
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
18년 (성인, 고령자)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Adult person, man or woman, staff of the Clermont-Ferrand University Hospital (medical or paramedical, medico-technical or administrative caregiver), having received the second dose of vaccine (or the single dose if the single-dose vaccination schedule) against COVID- 19 3 months +/- 15 days before the inclusion visit, as part of the national vaccination campaign, regardless of the type of vaccine administered.
- For the subgroup included before vaccination (study of the pre-vaccination cellular response): Adult person, man or woman, staff of Clermont-Ferrand University Hospital (medical or paramedical, medico-technical or administrative caregiver), receiving the 1st injection on the same day or in the 7 days before the inclusion visit, regardless of the type of vaccine administered
- Commitment to respect the schedule of visits provided for in the research protocol
- Able to give informed consent to participate in research
- Affiliation to a social security scheme
Exclusion Criteria:
- Pregnancy or breastfeeding in progress at inclusion, or planned during follow-up
- Person under guardianship, guardianship or legal protection
- Whether the vaccine received was experimental or not authorized
- Refusal of participation
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
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 |
|---|---|
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다른: Monitoring of the immune response
Immune response controlled with blood sample at 3, 6, 12, 18 and 24 months
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Blood sample at 3,6,12,18 and 24 months in order to assess the blood level of anti-S1 / RBD anticoprs
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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the blood level of anti-S1 / RBD antibodies
기간: 3 months
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temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
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3 months
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the blood level of anti-S1 / RBD antibodies
기간: 6 months
|
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
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6 months
|
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the blood level of anti-S1 / RBD antibodies
기간: 12 months
|
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
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12 months
|
|
the blood level of anti-S1 / RBD antibodies
기간: 24 months
|
temporal evolution of humoral immunity induced by the anti-COVID-19 vaccine, at 3, 6, 12 and 24 months after the second injection (or the single injection if single dose vaccination schedule), using two quantitative enzyme-linked immunosorbent assays (ELISA) targeting anti-S1 and anti-RBD antibodies.
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24 months
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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relationship between the level of antibodies detected by serological tests (ELISA) and the antibodies titrated using an in vitro neutralization test
기간: 3 months, 6 months, 12 months, 18 months, 24 months
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Comparison of the humoral response evaluated by serological tests with that analysed by neutralisation in vitro, on pairs of samples chosen to cover the variability of the response induced by vaccination between M3 and M24.
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3 months, 6 months, 12 months, 18 months, 24 months
|
|
anti-S lymphocyte response induced by the anti-COVID-19 vaccine
기간: 3 months, 6 months, 12 months, 18 months, 24 months
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Cellular immune response induced by the anti-COVID-19 vaccine evaluated by the anti-S lymphocyte response reflected by the determination of IFN-γ at the 3rd, 6th, 12th, 18th and 24th months after the second injection of vaccine (or the single injection if scheme single dose vaccine).
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3 months, 6 months, 12 months, 18 months, 24 months
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effect of age on immune response
기간: 3 months, 6 months, 12 months, 18 months, 24 months
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Study the effect of age on the various immune parameters studied, in general and in their temporal course
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3 months, 6 months, 12 months, 18 months, 24 months
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Intensity of immune response according to different comorbidities
기간: 3 months, 6 months, 12 months, 18 months, 24 months
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Study the effect of comorbidities on the various immune parameters studied, in general and in their temporal course
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3 months, 6 months, 12 months, 18 months, 24 months
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Intensity of immune response according to a previous COVID-19 infection or not
기간: 3 months, 6 months, 12 months, 18 months, 24 months
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Study the effect of a previous COVID-19 infection on the various immune parameters studied, in general and in their temporal course
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3 months, 6 months, 12 months, 18 months, 24 months
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Intensity of immune response according to the type of vaccine administered
기간: 3 months, 6 months, 12 months, 18 months, 24 months
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Study the effect of the type of vaccine administered on the various immune parameters studied, in general and in their temporal course
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3 months, 6 months, 12 months, 18 months, 24 months
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the cellular immune response directed against the Spike peptides of T lymphocytes before vaccination, between D-7 and the day of the 1st injection of vaccine
기간: Day 1
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Pre-vaccine anti-S cellular immune response reflected by the IFN-γ assay, for a subgroup of 50 volunteers then benefiting from the same follow-up until the 24th month
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Day 1
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genomic characteristics of the strain of SARS-CoV-2 in case of proven COVID-19 infection during follow-up
기간: up to 24 months
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Clinical description of subjects presenting with COVID-19 infection during follow-up, and genomic characteristics of their strain of SARS-CoV-2 by whole genome sequencing (next-generation sequencing).
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up to 24 months
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
간행물 및 유용한 링크
연구에 대한 정보 입력을 담당하는 사람이 자발적으로 이러한 간행물을 제공합니다. 이것은 연구와 관련된 모든 것에 관한 것일 수 있습니다.
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작 (실제)
2021년 5월 19일
기본 완료 (예상)
2023년 11월 1일
연구 완료 (예상)
2024년 5월 1일
연구 등록 날짜
최초 제출
2021년 5월 18일
QC 기준을 충족하는 최초 제출
2021년 5월 19일
처음 게시됨 (실제)
2021년 5월 21일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 5월 24일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 5월 21일
마지막으로 확인됨
2021년 5월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- RBHP 2021 HENQUELL
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
아니
미국 FDA 규제 기기 제품 연구
아니
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. .