Evaluation of Inactivated Vaccine in Healthy Adults Against Coronavirus Disease of 2019 (COVID-19)
2021년 11월 18일 업데이트: National Research Centre, Egypt
A Phase 1 Clinical Trial to Evaluate the Safety, Tolerability, and Immunogenicity of Inactivated Severe Acute Respiratory Syndrome Coronavirus-2 (SARS-CoV-2) Vaccine Against COVID-19 in Healthy Adults
In this phase 1 study, the inactivated virus vaccine National Research Centre (NRC) Vaccine-101 (VACC-101) will be investigated for its safety and immunogenicity in healthy volunteers with the aim of providing effective and safe protection against COVID-19.
연구 개요
상세 설명
This is a Phase I, Randomized, Open-Labeled Clinical trial. Eligible volunteers will be randomized in a 1:1:1 allocation ratio, into one of the three study arms using the Interactive Web Response Technology (IWRS).
Unscheduled visits can occur at any time during the study period outside the initially planned study visits, all the extra visits will be documented in the subjects' files. Volunteers will be randomized into one of the following arms to receive different doses of the Inactivated
SARS-COV-2 Vaccine "NRC-VACC-101" as an intramuscular (IM) Injection or Placebo:
Arm One:
Volunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart.
Arm Two:
Volunteers will receive two IM doses of the vaccine, concentrations of 6 mcg, 28 days apart.
Arm Three (Control arm):
Volunteers will receive two IM doses of the placebo, 28 days apart. The first 9 subjects will be initially vaccinated with their first dose, as per their assigned study arm determined by the randomization procedures and will be followed up until day 14 (visit 03). At this point in the study, the Data Safety and Monitoring Board (DSMB) will review safety data before proceeding with vaccinating the rest of the recruited subjects
연구 유형
중재적
등록 (예상)
72
단계
- 1단계
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 연락처
- 이름: Osama Azmy, MD
- 전화번호: +201223103084
- 이메일: osamaazmy@yahoo.com
연구 연락처 백업
- 이름: Clinical Trial Unit Clinical Trial Unit National Research Centre, MD
- 전화번호: +20237623009
- 이메일: ctu.mrce@nrc.sci.eg
연구 장소
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Giza
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Cairo, Giza, 이집트, 12622
- 모병
- Medical Research Centre of Excellence National Research Centre
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연락하다:
- Osama Azmy, MD
- 전화번호: +201223103084
- 이메일: osamaazmy@yahoo.com
-
-
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)
건강한 자원 봉사자를 받아들입니다
예
연구 대상 성별
모두
설명
Inclusion Criteria:
- Adults with age 18 to 50 years.
- Willingness.
- For married females of childbearing age: Willingness to practice continuous effective contraception for one year from the start of the study.
- Agreement to refrain from blood donation during the study.
- Body temperature is within the normal range (36.5 - 37.5°C).
- General good health as established by medical history, physical and laboratory examinations.
Exclusion Criteria:
- Pregnancy or lactation.
- Inability to provide informed consent.
- Recent receipt of any vaccination within 30 days prior to baseline.
- Planning to receive any vaccination during the course of the study.
- Prior receipt of Adenovirus vaccine, or any other Coronavirus vaccine.
- Recent receipt of any immunoglobulin within 90 days prior to baseline.
- Recent receipt of any blood product within 90 days prior to baseline.
Volunteers who are immunosuppressed or receiving immunosuppressive medications, including:
HIV infection, asplenia, recurrent severe infections, and the use of immunosuppressive medications within the past 6 months, except for topical steroids or short-term oral steroids (course lasting < 14 days).
- Currently taking any product (investigational or off-label) for prevention of COVID-19 disease.
- Having any autoimmune disease.
- History of allergic reactions for any of the vaccine components.
- History of angioedema.
- History of anaphylaxis.
- History of cancer.
- History of serious psychiatric conditions that are likely to affect participation in the study.
- Having bleeding disorders.
- Having chronic respiratory diseases.
- Having chronic cardiovascular disease, gastrointestinal disease, liver disease, renal disease, endocrine disorders, and neurological illness.
- Volunteers with BMI ≥ 40 Kg/m2 or ≤ 18 Kg/m2.
- Current alcohol abuse.
- Drug abuse within 5 years prior to baseline.
- History of laboratory-confirmed COVID-19 or seropositivity for SARS-CoV-2 or positive serum immunoglobulin M (IgM) and immunoglobulin G (IgG) to the SARS CoV-2 or abnormal chest CT-Scan (COVID-19 image) or positive pharyngeal/sputum swabs for SARS-CoV-2.
- Participation in other studies involving study intervention within 28 days prior to study entry and/or during study participation.
- High-risk population (volunteers who work in front-line health facilities or were in close contact with confirmed COVID-19 cases).
- Living in the same household as anyone at high risk of severe COVID-19.
- Any condition, according to the judgment of the investigator, that would interfere with the subject's ability to comply with all study requirements or that would place the subject at unacceptable risk by his/her participation in the study or impair the interpretation of the study data.
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: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
활성 비교기: NRC-VACC-101 vaccine 3 microgram
Volunteers will receive two IM doses of the vaccine, concentrations of 3 mcg, 28 days apart.
|
Inactivated SARS-COV-2 Vaccine/alum adjuvant preparation in addition to excipients (NRC-VACC- 101) administered as an IM Injection.
NRC-VACC-101 is provided as a single dose of inactivated vaccine of opaque white liquid free from visible particles filled in injection vial (2R) glass vials.
Each Dose of Covi Vax Vaccine contains 6 mcg antigen of A human coronavirus (hCoV)-19/Egypt/NRC-03/2020 SARS-CoV-2 strain.
다른 이름들:
|
|
활성 비교기: NRC-VACC-101 vaccine 6 microgram
Volunteers will receive two IM doses of the vaccine, concentrations of 6 mcg, 28 days apart.
|
Inactivated SARS-COV-2 Vaccine/alum adjuvant preparation in addition to excipients (NRC-VACC- 101) administered as an IM Injection.
NRC-VACC-101 is provided as a single dose of inactivated vaccine of opaque white liquid free from visible particles filled in injection vial (2R) glass vials.
Each Dose of Covi Vax Vaccine contains 6 mcg antigen of A human coronavirus (hCoV)-19/Egypt/NRC-03/2020 SARS-CoV-2 strain.
다른 이름들:
|
|
위약 비교기: Control arm
Volunteers will receive two IM doses of the placebo (excipients only), 28 days apart.
|
Inactivated SARS-COV-2 Vaccine/alum adjuvant preparation in addition to excipients (NRC-VACC- 101) administered as an IM Injection.
NRC-VACC-101 is provided as a single dose of inactivated vaccine of opaque white liquid free from visible particles filled in injection vial (2R) glass vials.
Each Dose of Covi Vax Vaccine contains 6 mcg antigen of A human coronavirus (hCoV)-19/Egypt/NRC-03/2020 SARS-CoV-2 strain.
다른 이름들:
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The safety of NRC-VACC-101 Vaccine
기간: Follow up for any solicited adverse event(AE) reported within 7 days
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To evaluate the safety of the proposed regimens of NRC-VACC-101
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Follow up for any solicited adverse event(AE) reported within 7 days
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The tolerability of NRC-VACC-101 Vaccine
기간: Follow up for any AE within 28 days of each dose
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To evaluate the tolerability of the proposed regimens of NRC-VACC-101 Vaccine in the healthy population
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Follow up for any AE within 28 days of each dose
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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The seroconversion rate of neutralizing antibodies
기간: The evaluation of the antibody will be measured up to one month of each dose
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To evaluate the seroconversion rate of neutralizing antibodies resulting from the NRC-VACC-101 Vaccine
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The evaluation of the antibody will be measured up to one month of each dose
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To recommend the dose level of NRC-VACC-101 Vaccine for the phase II trial.
기간: The evaluation of the Microneutralization Assay will be assessed up to one month of each dose
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The evaluation of the Microneutralization Assay curve will give an overview of the dose possible suggested dose of NRC-VACC-101 Vaccine for the phase II trial
|
The evaluation of the Microneutralization Assay will be assessed up to one month of each dose
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
수사관
- 수석 연구원: Osama Azmy, MD, Medical Research and Clinical Studies Institute National Research Centre, Dokki, Giza, Egypt.
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 11월 14일
기본 완료 (예상)
2023년 2월 23일
연구 완료 (예상)
2023년 5월 23일
연구 등록 날짜
최초 제출
2021년 11월 12일
QC 기준을 충족하는 최초 제출
2021년 11월 18일
처음 게시됨 (실제)
2021년 11월 22일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2021년 11월 22일
QC 기준을 충족하는 마지막 업데이트 제출
2021년 11월 18일
마지막으로 확인됨
2021년 11월 1일
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- NO-B041
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
예
IPD 계획 설명
Data will be shared upon individual request.
IPD 공유 기간
About one year after completion of the trial
IPD 공유 액세스 기준
Data will be shared upon individual request by contacting the sponsor of the trial.
IPD 공유 지원 정보 유형
- 연구_프로토콜
- ICF
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. .