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A Heterologous 3rd COVID-19 Vaccine of MVC-COV1901 to Evaluate Immunogenicity and Safety in Adults With ChAdOx1-nCov-19

2021년 12월 7일 업데이트: Taoyuan General Hospital

A Parallel Group, Prospective, Randomized, Two-arm, Open-label Study to Evaluate the Immunogenicity, Safety, and Tolerability of Heterologous 3rd Boost of MVC-COV1901 in Adults With 2 Doses of ChAdOx1-nCov-19 in 3 Months and 6 Months

This primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titers in adult participants in order to demonstrate the immunogenicity and safety of heterologous third-boost with MVC-COV1901, in terms of the neutralizing antibody GMTs at 28 days after the study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity by the antigen-specific immunoglobulin as well as the potential efficacy of study intervention in preventing COVID-19. This study is aimed to recruit participants at single study site in Northern Taiwan.

연구 개요

상세 설명

This a parallel group, prospective, randomized, two-arm, open-label, single-center study to be conducted in approximately 200 healthy participants aged 20 to 64 years who have had their two doses of ChAdOx1-nCov-19 (Astra Zeneca). Preparation and administration of study intervention will be performed by authorized unblinded site personnel. Eligible participants will receive MVC-COV1901 vaccine after a 3-month (Group A: < 16 weeks and ≥ 12 weeks) or 6-month (Group B: < 28 weeks and ≥ 24 weeks) interval apart from their second dose of ChAdOx1-nCov-19.

The study consists of 6 on-site visits:

  • Day -28 to Day 1, Visit 1 (Screening)
  • Day 1, Visit 2 (study intervention) : randomization Group A and B

Group A:

  • Day 1, Visit 2: treatment
  • Day 29 ± 3 days, Visit 3
  • Day 85 ± 3 days, Visit 4
  • Day 169 ± 3 days, Visit 5

Group B:

  • Day 1, Visit 2
  • Day 85 ± 3 days, Visit 3: treatment
  • Day 113 ± 3 days, Visit 4
  • Day 169 ± 3 days, Visit 5

연구 유형

중재적

등록 (예상)

200

단계

  • 4단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

      • Taoyuan, 대만
        • 모병
        • Taoyuan General Hospital
        • 연락하다:

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

20년 (성인)

건강한 자원 봉사자를 받아들입니다

연구 대상 성별

모두

설명

Inclusion Criteria:

  1. Male or female participant aged 20 to 64 years at randomization.
  2. Has received two doses of the ChAdOx1-nCov-19 (Astra-Zeneca) 12 to 16 weeks before randomization.
  3. Female participant must:

    1. Be either of non-childbearing potential, i.e. surgically sterilized (defined as having undergone hysterectomy and/or bilateral oophorectomy and/or bilateral salpingectomy; tubal ligation alone is not considered sufficient) or one year post-menopausal;
    2. Or, if of childbearing potential, be abstinent or agree to use medically effective contraception from 14 days before screening to 30 days following the last administration of study intervention. Acceptable forms include:

    i.Implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine system ii.Established use of hormonal methods (injectable, pill, patch or ring) combined with barrier methods of contraception: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository c.Have a negative pregnancy test

  4. Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
  5. Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent.

Exclusion Criteria:

  1. Pregnant or breast feeding or have plan to become pregnant within 30 days after the last administration of study intervention.
  2. Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention.
  3. Administered any licensed live-attenuated vaccines within 28 days or other licensed non-live-attenuated vaccines within 7 days prior to the first dose of study intervention.
  4. Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention.
  5. Currently receiving or anticipate to receive concomitant immunosuppressive or immune-modifying therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or < 2 weeks of daily receipt of prednisone less than 20 mg or equivalent) within 12 weeks prior to the first dose of study intervention.
  6. Currently receiving or anticipate to receive treatment with tumor necrosis factor (TNF)-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks prior to the first dose of study intervention.
  7. Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention.
  8. Has received any other investigational or licensed COVID-19 vaccine.
  9. Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
  10. A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer (exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the investigator).
  11. Bleeding disorder considered a contraindication to IM injection or phlebotomy.
  12. Known SARS-CoV-2 infection in the recent 3 months prior to the first dose of study intervention.
  13. A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome.
  14. Participant who, in the investigator's judgement, is not in a stable condition and by participating in the study could adversely affect the safety of the participant, interfere with adherence to study requirements or evaluation of any study endpoint. This may include a participant with ongoing acute diseases, severe infections, autoimmune disease, laboratory abnormality or serious medical conditions in the following systems: cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, or psychiatric.
  15. A history of hypersensitivity to any vaccine or a history of allergic disease or reactions likely to be exacerbated by any component of the MVC-COV1901.
  16. Body (oral, rectal, or ear) temperature ≥ 38.0°C or acute illness (not including minor illnesses such as diarrhea or mild upper respiratory tract infection at the discretion of the investigator) within 2 days before the first dose of study intervention.

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
실험적: MVC-COV1901 vaccine (3-month Interval)
There will be approximately 100 participants (Group A) who had received 2 doses of ChAdOx1-nCov-19 and will be vaccinated with MVC-COV1901 at Day 1
MVC-COV1901 vaccine after a 3-month Interval
실험적: MVC-COV1901 vaccine (6-month Interval)
There will be approximately 100 participants (Group B) who had received 2 doses of ChAdOx1-nCov-19 and will be vaccinated with MVC-COV1901 at Day 85.
MVC-COV1901 vaccine after a 6-month Interval

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Primary Immunogenicity
기간: Day1 to 28 days after vaccination

To evaluate the immunogenicity of heterologous third-boost (MVC-COV1901) in 3 months, compared to 6 months, in terms of neutralizing antibody

Geometric Mean Titers (GMT)

Day1 to 28 days after vaccination
Primary Safety
기간: Day1 to 28 days after vaccination

To evaluate the safety and tolerability of heterologous third-boost (MVC-COV1901) from Day 1 to 28 days after the study intervention

The number and percentage of participants with the occurrence of:

  • Solicited local adverse events (AEs)
  • Solicited systemic AEs
  • Unsolicited AEs
Day1 to 28 days after vaccination

2차 결과 측정

결과 측정
측정값 설명
기간
Secondary Immunogenicity
기간: Day 1 and Day 169

To evaluate the immunogenicity of heterologous third-boost (MVC-COV1901) in terms of antigen-specific immunoglobulin titers

GMT

Day 1 and Day 169
Secondary Safety
기간: Day 1 to Day169

To evaluate the safety of heterologous third-boost (MVC-COV1901), over the study period

The number and percentage of participants with the occurrence of:

  • MAAEs
  • AESIs
  • VAED
  • SAEs
Day 1 to Day169

기타 결과 측정

결과 측정
측정값 설명
기간
Exploratory Efficacy
기간: Day 1 to Day 169

To estimate the efficacy of heterologous third-boost (MVC COV1901), in the prevention of COVID-19

  • Number of laboratory-confirmed COVID-19 cases occurring ≥ 7 days after study intervention.
  • Number of laboratory-confirmed COVID-19 severe cases occurring ≥ 7 days after study intervention.
Day 1 to Day 169

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

수사관

  • 수석 연구원: Chieh-Yu Cheng, MD.PhD., Taoyuan General Hospital

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 10월 7일

기본 완료 (예상)

2022년 3월 1일

연구 완료 (예상)

2022년 7월 1일

연구 등록 날짜

최초 제출

2021년 10월 17일

QC 기준을 충족하는 최초 제출

2021년 10월 18일

처음 게시됨 (실제)

2021년 10월 27일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2021년 12월 23일

QC 기준을 충족하는 마지막 업데이트 제출

2021년 12월 7일

마지막으로 확인됨

2021년 12월 1일

추가 정보

이 연구와 관련된 용어

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

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. .

코로나19 백신에 대한 임상 시험

MVC-COV1901(3 Months)에 대한 임상 시험

3
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