A Heterologous 3rd COVID-19 Vaccine of MVC-COV1901 to Evaluate Immunogenicity and Safety in Adults With ChAdOx1-nCov-19
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ClinicalTrials.gov Identifier: NCT05097053 |
Recruitment Status :
Recruiting
First Posted : October 27, 2021
Last Update Posted : December 23, 2021
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Condition or disease | Intervention/treatment | Phase |
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COVID-19 Vaccine | Biological: MVC-COV1901(3 Months) Biological: MVC-COV1901(6 Months) | Phase 4 |
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
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Prevention |
Official Title: | 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 |
Actual Study Start Date : | October 7, 2021 |
Estimated Primary Completion Date : | March 2022 |
Estimated Study Completion Date : | July 2022 |

Arm | Intervention/treatment |
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Experimental: 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
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Biological: MVC-COV1901(3 Months)
MVC-COV1901 vaccine after a 3-month Interval |
Experimental: 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.
|
Biological: MVC-COV1901(6 Months)
MVC-COV1901 vaccine after a 6-month Interval |
- Primary Immunogenicity [ Time Frame: 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)
- Primary Safety [ Time Frame: 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
- Secondary Immunogenicity [ Time Frame: Day 1 and Day 169 ]
To evaluate the immunogenicity of heterologous third-boost (MVC-COV1901) in terms of antigen-specific immunoglobulin titers
GMT
- Secondary Safety [ Time Frame: 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
- Exploratory Efficacy [ Time Frame: 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.

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Ages Eligible for Study: | 20 Years to 64 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female participant aged 20 to 64 years at randomization.
- Has received two doses of the ChAdOx1-nCov-19 (Astra-Zeneca) 12 to 16 weeks before randomization.
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Female participant must:
- 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;
- 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
- Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
- Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent.
Exclusion Criteria:
- Pregnant or breast feeding or have plan to become pregnant within 30 days after the last administration of study intervention.
- Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention.
- 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.
- Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention.
- 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.
- 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.
- Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention.
- Has received any other investigational or licensed COVID-19 vaccine.
- Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
- 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).
- Bleeding disorder considered a contraindication to IM injection or phlebotomy.
- Known SARS-CoV-2 infection in the recent 3 months prior to the first dose of study intervention.
- A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome.
- 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.
- 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.
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05097053
Contact: Chieh-Yu Cheng, MD.PhD. | +886-3-3699721 ext 8311 | s841060@gm.ym.edu.tw | |
Contact: Shu-Hsing Cheng, MD.PhD. | +886-3-3699721 ext 8311 | shcheng@mail.tygh.gov.tw |
Taiwan | |
Taoyuan General Hospital | Recruiting |
Taoyuan, Taiwan | |
Contact: Chieh-Yu Cheng, M.D., Ph.D. +886-3-3699721 ext 8311 s841060@gm.ym.edu.tw |
Principal Investigator: | Chieh-Yu Cheng, MD.PhD. | Taoyuan General Hospital |
Responsible Party: | Taoyuan General Hospital |
ClinicalTrials.gov Identifier: | NCT05097053 |
Other Study ID Numbers: |
TYGH110044 |
First Posted: | October 27, 2021 Key Record Dates |
Last Update Posted: | December 23, 2021 |
Last Verified: | December 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
COVID-19 Vaccine |
COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases |
Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases |