COVID-19 VaccinePhase 4NCT05097053
A Heterologous 3rd COVID-19 Vaccine of MVC-COV1901 to Evaluate Immunogenicity and Safety in Adults With ChAdOx1-nCov-19
A Phase 4 study testing MVC-COV1901(3 Months) and MVC-COV1901(6 Months) in people with COVID-19 Vaccine, run by Taoyuan General Hospital at 1 site in Taiwan.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 64 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19 Vaccine
- What is being tested?
- MVC-COV1901(3 Months) and MVC-COV1901(6 Months)
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Oct 2021to Jul 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 64 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Taoyuan General Hospital
Taoyuan
Chieh-Yu Cheng, M.D., Ph.D., +886-3-3699721 ext. 8311, s841060@gm.ym.edu.tw
About this study
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
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.
Read the detailed description
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
- Conditions
- COVID-19 Vaccine
- Being tested
- MVC-COV1901(3 Months), MVC-COV1901(6 Months)
- Keywords
- COVID-19 Vaccine
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVC-COV1901(3 Months)Biological
MVC-COV1901 vaccine after a 3-month Interval
MVC-COV1901(6 Months)Biological
MVC-COV1901 vaccine after a 6-month Interval
| Study group | Role | What they receive |
|---|---|---|
| MVC-COV1901 vaccine (3-month Interval) | Experimental | 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 Receives: Biological: MVC-COV1901(3 Months) |
| MVC-COV1901 vaccine (6-month Interval) | Experimental | 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. Receives: Biological: MVC-COV1901(6 Months) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary Immunogenicity
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)
Measured: Day1 to 28 days after vaccination
Primary Safety
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
Measured: Day1 to 28 days after vaccination
Secondary outcomes (2)
Secondary Immunogenicity
To evaluate the immunogenicity of heterologous third-boost (MVC-COV1901) in terms of antigen-specific immunoglobulin titers
GMT
Measured: Day 1 and Day 169
Secondary Safety
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
Measured: Day 1 to Day169
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2021
- Study start7 Oct 2021
- Primary completionMar 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19 VaccineStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taoyuan General Hospital
- Sponsor type
- Other government
- Collaborators
- Medigen Vaccine Biologics Corp.
- Responsible party
- Sponsor
- Investigators
- Chieh-Yu Cheng, MD.PhD., Principal investigator, Taoyuan General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05097053
- Sponsor's protocol ID
- TYGH110044
- Status last verified
- Dec 2021
- First submitted
- 17 Oct 2021
- Last updated
- 23 Dec 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05097053
- Acronym / sponsor ID
- TYGH110044
- Conditions
- COVID-19 Vaccine
- Keywords
- COVID-19 Vaccine
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Taoyuan General HospitalOther government
- Collaborators
- Medigen Vaccine Biologics Corp.
- Study start
- 7 Oct 2021 (actual)
- Primary completion
- Mar 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 27 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| MVC-COV1901 vaccine (3-month Interval) | Experimental | Biological: MVC-COV1901(3 Months)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 (6-month Interval) | Experimental | Biological: MVC-COV1901(6 Months)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. |
Who may qualify
- Ages
- 20 to 64 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- 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.
- Female participant must:
- 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.
Key exclusion criteria (16 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MVC-COV1901(3 Months)MVC-COV1901 vaccine after a 3-month Interval | Biological | MVC-COV1901 vaccine (3-month Interval) |
| MVC-COV1901(6 Months)MVC-COV1901 vaccine after a 6-month Interval | Biological | MVC-COV1901 vaccine (6-month Interval) |
Primary outcome
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
2 secondary outcomes
Secondary Immunogenicity
Time frame: Day 1 and Day 169
Secondary Safety
Time frame: Day 1 to Day169
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Chieh-Yu Cheng, MD.PhD. principal investigator
Taoyuan General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing MVC-COV1901(3 Months) and MVC-COV1901(6 Months) in people with COVID-19 Vaccine, run by Taoyuan General Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Dec 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Chieh-Yu Cheng, MD.PhD. (+886-3-3699721 ext. 8311, s841060@gm.ym.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary Immunogenicity (time frame: Day1 to 28 days after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Dec 2021.