Evaluation of Clinical and Antibody Response to Covid-19 Vaccination Strategy in TBRI, Egypt
연구 개요
상세 설명
SARS-CoV-2 has been in the human population for more than a year now, causing severe disease in some and resulting in a pandemic that continues to put severe strain on economies and healthcare infrastructures worldwide. Vaccination is considered as one of the greatest successes in medical history. Based on prior experience with the development of SARS-CoV vaccines, all COVID-19 vaccines must be subjected to the tests for protective effects and harmful risks derived from antibody-dependent enhancement that may contribute to augmented infectivity and/or eosinophilic infiltration. The SARS-CoV-2 vaccine is now being developed urgently in several different ways.
In the UK, the first three vaccines have emergency use authorization, and a national rollout is in progress. Many other countries are also instigating large scale vaccination programmes. Assessment of the safety and efficacy of vaccines against the severe acute respiratory syndrome coronavirus (SARS-CoV-2) in different populations is essential .
The UK government recently decided to extend the interval between the first dose of the Pfizer BioNTech and AstraZeneca COVID-19 vaccines from 3 weeks to 12 weeks to maximise the number of people receiving the initial dose, despite the trials only providing vaccine efficacy data based on a schedule of 21 days between doses.
Many reports were raised claiming Astrazenica vaccine for the development of vascular thrombosis and studies are not finalized regarding this issue .
China is regarded as one of the world's leading countries in SARS-CoV-2 vaccine development, up to date the last inactivated vaccine international clinical (Phase III) trial was launched in the United Arab Emirates by Sinopharm China National Biotec Group (CNBG).The ability to track and trace vaccines through the vaccine supply chain down to persons vaccinated has to be enhanced.
연구 유형
등록 (예상)
단계
- 3단계
연락처 및 위치
연구 장소
-
-
-
Giza, 이집트
- 모병
- Samia El-Shishtawy
-
연락하다:
- Samia H El-Shishtawy, Assi. prof
- 전화번호: 01003661563
- 이메일: crc.tbri@gmai.com
-
-
참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- All male and female above 18 years
Exclusion Criteria:
- age below 18 years -pregnancy-
- fever
- IGM positive for covid 19
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 상영
- 할당: 무작위
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
다른: 1- Before vaccination:
To detect:
|
COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
|
|
다른: 2-7 days after the first dose
Measuring D-dimer
|
COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
|
|
다른: 3-Before the second dose:
To detect IgG and IgM To detect the level of Covid-19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured.
To detect the response of the immune system to the vaccine.
|
COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
|
|
다른: 4-After 3 months from the second dose:
To detect the level ofCovid-19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured.
To detect the response of the immune system to the vaccine.
|
COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
|
|
다른: 5-After 6 months from the second dose:
To detect the level ofCovid 19 Ig G antibodies titer in the blood, Quantitative Ig G titer should be measured.
To detect the response of the immune system to the vaccine.
|
COVID-19 vaccines should be administered by intramuscular (IM) injection, preferably into the deltoid muscle of the upper arm.
Individuals who have minimal muscle mass in the deltoid area of the upper arm, or a particular reason to avoid immunization in the deltoid muscle, can be given their vaccine in the vastuslateralis muscle in the thigh if necessary.
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
to develop IgG antibody
기간: seven to ten days
|
These antibodies indicate that you may have had COVID 19 in the recent past and have developed antibodies that may protect you from future infection.
It is unknown at this point how much protectionantibodies might provide against reinfection.
This group of individuals should receive the vaccine.
Quantitative Ig G titer should be measured.
|
seven to ten days
|
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (예상)
기본 완료 (예상)
연구 완료 (예상)
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
- 00022021
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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. .
코로나19에 대한 임상 시험
-
Texas Woman's UniversityNational Institutes of Health (NIH)아직 모집하지 않음COVID19 테스트
-
Cairo UniversityKasr El Aini Hospital알려지지 않은
-
Assistance Publique - Hôpitaux de Paris알려지지 않은
-
Brugmann University Hospital모병
-
Istituti Clinici Scientifici Maugeri SpAIstituto Auxologico Italiano; Azienda Ospedaliera Bolognini di Seriate Bergamo; Azienda Socio... 그리고 다른 협력자들완전한
-
Abderrahmane Mami HospitalDacima Consulting; Eshmoun Clinical Research Center빼는
-
Aarhus University HospitalUniversity of Aarhus; Pharma Nord완전한
Astrazenica vaccine에 대한 임상 시험
-
Johns Hopkins UniversityMerck Sharp & Dohme LLC완전한
-
The Second Affiliated Hospital of Chongqing Medical...모병
-
Radboud University Medical Center모집하지 않고 적극적으로