A Heterologous 3rd COVID-19 Vaccine of MVC-COV1901 to Evaluate Immunogenicity and Safety in Adults With ChAdOx1-nCov-19
NCT ID: NCT05097053
Last Updated: 2021-12-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE4
200 participants
INTERVENTIONAL
2021-10-07
2022-07-31
Brief Summary
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Detailed Description
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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
Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
NONE
Study Groups
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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(3 Months)
MVC-COV1901 vaccine after a 3-month Interval
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(6 Months)
MVC-COV1901 vaccine after a 6-month Interval
Interventions
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MVC-COV1901(3 Months)
MVC-COV1901 vaccine after a 3-month Interval
MVC-COV1901(6 Months)
MVC-COV1901 vaccine after a 6-month Interval
Eligibility Criteria
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Inclusion Criteria
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
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.
20 Years
64 Years
ALL
Yes
Sponsors
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Medigen Vaccine Biologics Corp.
INDUSTRY
Taoyuan General Hospital
OTHER_GOV
Responsible Party
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Principal Investigators
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Chieh-Yu Cheng, MD.PhD.
Role: PRINCIPAL_INVESTIGATOR
Taoyuan General Hospital
Locations
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Taoyuan General Hospital
Taoyuan District, , Taiwan
Countries
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Central Contacts
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Facility Contacts
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Chieh-Yu Cheng, M.D., Ph.D.
Role: primary
Other Identifiers
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TYGH110044
Identifier Type: -
Identifier Source: org_study_id