COVID-19Phase 1NCT04487210
A Study to Evaluate the Safety and Immunogenicity of MVC-COV1901 Against COVID-19
A Phase 1 study testing MVC-COV1901 in people with COVID-19, run by Medigen Vaccine Biologics Corp. at 1 site in Taiwan.
Trial summary
This is a phase I prospective, open-labeled, single-center study to evaluate the safety and immunogenicity of MVC-COV1901. Read more about this study
- Who is it for?
- Ages 20 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- MVC-COV1901
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteTaiwan
- Study dates
- 7 Oct 2020to 6 Dec 2021
- Phase
- Phase 1
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female healthy volunteer ≥20 and <50 years of age
- Subject free of ongoing acute diseases or serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigator's opinion could interfere with the results of the trial or adversely affect the safety of the subject
- Female subject 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, must be abstinent or agree to use medically effective contraception from 14 days before screening to 30 days following last injection of study vaccines. Acceptable forms include:
- Implanted hormonal methods of contraception or placement of an intrauterine device (IUD) or intrauterine system (IUS)
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- 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) withspermicidal foam/gel/film/cream/suppository
- Have a negative pregnancy test
- Subject is willing and able to comply with all required study visits and follow-up required by this protocol
- Subject has no overseas travel within 14 days of screening and will not have any throughout the study period
- Subject must provide written informed consent or the Subject's legal representative must understand and consent to the procedure
Who cannot join
- Receiving any investigational intervention either currently or within 30 days of first dose;
- Subject (particularly who is a healthcare worker) with previous known or potential exposure to SARS CoV-1 or 2 viruses (EXCEPT for those who have been tested negative and the 14-days self-managements/ home quarantines/ home isolations are completed), or received any other COVID-19 vaccine;
- Administration of any vaccine within 4 weeks of first dose;
- A BMI greater than or equal to 30 kg/m2;
- Subject with 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;
- Administration of any blood product or intravenous immunoglobulin administration within 12 weeks of first dose;
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- Pregnancy or breast feeding or have plans to become pregnant in 30 days after last injection of study vaccines;
- History of positive serologic test for HIV, hepatitis B surface antigen (HBsAg) or any potentially communicable infectious disease as determined by the investigator or Medical Monitor;
- Positive serologic test for hepatitis C (EXCEPTION: successful treatment with confirmation of sustained virologic response);
- Baseline evidence of kidney disease as measured by creatinine greater than 1.5 mg/dL;
- Screening laboratory tests with Grade 2 or higher abnormality (Toxicity Grading Scale for Healthy Adult and Adolescent Volunteers Enrolled in Preventive Vaccine Clinical Trials, September 2007);
- Immunosuppressive illness including hematologic malignancy, history of solid organ or bone marrow transplantation;
- A history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, thyroiditis, etc.);
- Current or anticipated concomitant immunosuppressive therapy (excluding inhaled, topical skin and/or eye drop-containing corticosteroids, low-dose methotrexate, or less than prednisone 20 mg/day or equivalent) within 12 weeks of first dose;
- Current or anticipated treatment with TNF-α inhibitors, e.g. infliximab, adalimumab, etanercept within 12 weeks of first dose;
- Prior major surgery or any radiation therapy within 12 weeks of first dose;
- Alcohol or drug abuse or dependence, psychiatric, addictive, or any disorder that, in the opinion of the investigator, would interfere with adherence to study requirements or assessment of immunologic endpoints; or any illness or condition that in the opinion of the investigator may affect the safety of the participant or the evaluation of any study endpoint;
- Presence of keloid scar formation or hypertrophic scar as a clinically significant medical condition, tattoos or wound covering the injection site area;
- Body (oral, rectal or ear) temperature ≥ 38.0°C or acute illness within 2 days of first dose, or acute respiratory illness within 14 days of first dose;
- Screening laboratory test of antinuclear antibody (ANA), anti-dsDNA antibody, anti-neutrophil cytoplasmic antibodies (ANCA, including cytoplasmic ANCA (c-ANCA), perinuclear ANCA (p-ANCA)) with the value higher than upper normal limit;
- Abnormal screening electrocardiography (ECG) with clinically significant findings as reviewed by investigator.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I, Prospective, Open-Labeled Study to Evaluate the Safety and Immunogenicity of MVC-COV1901
This is a phase I prospective, open-labeled, single-center study to evaluate the safety and immunogenicity of MVC-COV1901.
Read the detailed description
This is a phase I prospective, open-labeled, single-center study to evaluate the safety and immunogenicity of MVC-COV1901. This study is a dose escalation study with three separate arms for subjects at the age of ≥20 and <50 years. The vaccination schedule for primary regimen consists of two doses of MVC-COV1901 for each study subject, administered by intramuscular (IM) injection 0.5mL in the deltoid region of non-dominant arm preferably 28 days apart, on Day 1 and Day 29. Subjects will receive a single booster vaccination of MVC-COV1901 on Day 209, 180 days after completion of the primary regimen.
- Conditions
- COVID-19
- Being tested
- MVC-COV1901
- Keywords
- COVID-19 vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MVC-COV1901Biological
MVC-COV1901 is formulated in the different dosages of Spike (S) protein with CpG 1018 and aluminum content as adjuvant.
| Study group | Role | What they receive |
|---|---|---|
| Phase 1a (Low Dose) | Experimental | 15 subjects will be enrolled to receive Low-dose S-protein with adjuvant MVC-COV1901. Receives: Biological: MVC-COV1901 |
| Phase 1b (Medium Dose) | Experimental | 15 subjects will be enrolled to receive Medium-dose S-protein with adjuvant MVC-COV1901. Receives: Biological: MVC-COV1901 |
| Phase 1c (High Dose) | Experimental | 15 subjects will be enrolled to receive High-dose S-protein with adjuvant MVC-COV1901. Receives: Biological: MVC-COV1901 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of MVC-COV1901
Incidence of solicited adverse events (AEs) after vaccination, Incidence of unsolicited AEs and other AEs after vaccination, Incidence of laboratory abnormality after vaccination, Incidence of adverse event of special interest (AESI) and serious adverse events (SAEs) after vaccination
Measured: Day 1 to 28 days after second vaccination
Secondary outcomes (8)
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
Geometric mean titer (GMT)
Measured: 14 days, 28 days after each vaccination, and 180 days after second vaccination.
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
Seroconversion rate (SCR)
Measured: 14 days, 28 days after each vaccination, and 180 days after second vaccination.
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
GMT ratio
Measured: 14 days, 28 days after each vaccination, and 180 days after second vaccination.
Immunogenicity (antigen specific cellular immune responses)
The positive rate of cellular mediated immune response
Measured: 28 days and 180 days after second vaccination
Safety of MVC-COV1901
Incidence of other adverse events, Incidence of adverse event of special interest (AESI) and serious adverse events (SAEs) within the study period
Measured: Day 1 to Day 209
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
Geometric mean titer (GMT)
Measured: 28 days and 180 days after the booster vaccination.
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
Seroconversion rate (SCR)
Measured: 28 days and 180 days after the booster vaccination.
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
GMT ratio
Measured: 28 days and 180 days after the booster vaccination.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2020
- Study start7 Oct 2020
- Primary completion1 Jun 2021
- Study completion6 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medigen Vaccine Biologics Corp.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04487210
- Sponsor's protocol ID
- CT-COV-11
- Status last verified
- Aug 2021
- First submitted
- 22 Jul 2020
- Last updated
- 31 Jan 2022
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hsieh SM, Chang SC, Cheng HY, Shih SR, Lien CE. Durability and Immunogenicity of Neutralizing Antibodies Response Against Omicron Variants After Three Doses of Subunit SARS-CoV-2 Vaccine MVC-COV1901: An Extension to an Open-Label, Dose-Escalation Phase 1 Study. Infect Dis Ther. 2022 Aug;11(4):1493-1504. doi: 10.1007/s40121-022-00652-6. Epub 2022 May 17.
PubMed 35579840Hsieh SM, Liu WD, Huang YS, Lin YJ, Hsieh EF, Lian WC, Chen C, Janssen R, Shih SR, Huang CG, Tai IC, Chang SC. Safety and immunogenicity of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVC-COV1901) Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose-escalation study. EClinicalMedicine. 2021 Aug;38:100989. doi: 10.1016/j.eclinm.2021.100989. Epub 2021 Jun 26.
PubMed 34222848
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I, Prospective, Open-Labeled Study to Evaluate the Safety and Immunogenicity of MVC-COV1901
- ClinicalTrials.gov ID
- NCT04487210
- Acronym / sponsor ID
- CT-COV-11
- Conditions
- COVID-19
- Keywords
- COVID-19 vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Medigen Vaccine Biologics Corp.Industry (pharma, biotech, devices)
- Study start
- 7 Oct 2020 (actual)
- Primary completion
- 1 Jun 2021 (actual)
- Study completion
- 6 Dec 2021 (actual)
- First posted
- 27 Jul 2020 (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 is a phase I prospective, open-labeled, single-center study to evaluate the safety and immunogenicity of MVC-COV1901.
Detailed description
This is a phase I prospective, open-labeled, single-center study to evaluate the safety and immunogenicity of MVC-COV1901. This study is a dose escalation study with three separate arms for subjects at the age of ≥20 and <50 years. The vaccination schedule for primary regimen consists of two doses of MVC-COV1901 for each study subject, administered by intramuscular (IM) injection 0.5mL in the deltoid region of non-dominant arm preferably 28 days apart, on Day 1 and Day 29. Subjects will receive a single booster vaccination of MVC-COV1901 on Day 209, 180 days after completion of the primary regimen.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Phase 1a (Low Dose) | Experimental | Biological: MVC-COV190115 subjects will be enrolled to receive Low-dose S-protein with adjuvant MVC-COV1901. |
| Phase 1b (Medium Dose) | Experimental | Biological: MVC-COV190115 subjects will be enrolled to receive Medium-dose S-protein with adjuvant MVC-COV1901. |
| Phase 1c (High Dose) | Experimental | Biological: MVC-COV190115 subjects will be enrolled to receive High-dose S-protein with adjuvant MVC-COV1901. |
Who may qualify
- Ages
- 20 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Male or female healthy volunteer ≥20 and <50 years of age
- Subject free of ongoing acute diseases or serious medical conditions (e.g. concomitant illness) such as cardiovascular (e.g. New York Heart Association grade III or IV), hepatic (e.g. Child-Pugh Class C), psychiatric condition (e.g. alcoholism, drug abuse), medical history, physical findings, or laboratory abnormality that in the investigator's opinion could interfere with the results of the trial or adversely affect the safety of the subject
- Female subject must be:
- Subject is willing and able to comply with all required study visits and follow-up required by this protocol
- Subject has no overseas travel within 14 days of screening and will not have any throughout the study period
Key exclusion criteria (21 listed)
- Receiving any investigational intervention either currently or within 30 days of first dose;
- Subject (particularly who is a healthcare worker) with previous known or potential exposure to SARS CoV-1 or 2 viruses (EXCEPT for those who have been tested negative and the 14-days self-managements/ home quarantines/ home isolations are completed), or received any other COVID-19 vaccine;
- Administration of any vaccine within 4 weeks of first dose;
- A BMI greater than or equal to 30 kg/m2;
- Subject with 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;
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-COV1901MVC-COV1901 is formulated in the different dosages of Spike (S) protein with CpG 1018 and aluminum content as adjuvant. | Biological | Phase 1a (Low Dose), Phase 1b (Medium Dose), Phase 1c (High Dose) |
Primary outcome
Safety of MVC-COV1901
Time frame: Day 1 to 28 days after second vaccination
Incidence of solicited adverse events (AEs) after vaccination, Incidence of unsolicited AEs and other AEs after vaccination, Incidence of laboratory abnormality after vaccination, Incidence of adverse event of special interest (AESI) and serious adverse events (SAEs) after vaccination
8 secondary outcomes
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
Time frame: 14 days, 28 days after each vaccination, and 180 days after second vaccination.
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
Time frame: 14 days, 28 days after each vaccination, and 180 days after second vaccination.
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
Time frame: 14 days, 28 days after each vaccination, and 180 days after second vaccination.
Immunogenicity (antigen specific cellular immune responses)
Time frame: 28 days and 180 days after second vaccination
Safety of MVC-COV1901
Time frame: Day 1 to Day 209
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
Time frame: 28 days and 180 days after the booster vaccination.
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
Time frame: 28 days and 180 days after the booster vaccination.
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
Time frame: 28 days and 180 days after the booster vaccination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2022.
- Derived from this study: PubMed 35579840Hsieh SM, Chang SC, Cheng HY, Shih SR, Lien CE. Durability and Immunogenicity of Neutralizing Antibodies Response Against Omicron Variants After Three Doses of Subunit SARS-CoV-2 Vaccine MVC-COV1901: An Extension to an Open-Label, Dose-Escalation Phase 1 Study. Infect Dis Ther. 2022 Aug;11(4):1493-1504. doi: 10.1007/s40121-022-00652-6. Epub 2022 May 17.
- Derived from this study: PubMed 34222848Hsieh SM, Liu WD, Huang YS, Lin YJ, Hsieh EF, Lian WC, Chen C, Janssen R, Shih SR, Huang CG, Tai IC, Chang SC. Safety and immunogenicity of a Recombinant Stabilized Prefusion SARS-CoV-2 Spike Protein Vaccine (MVC-COV1901) Adjuvanted with CpG 1018 and Aluminum Hydroxide in healthy adults: A Phase 1, dose-escalation study. EClinicalMedicine. 2021 Aug;38:100989. doi: 10.1016/j.eclinm.2021.100989. Epub 2021 Jun 26.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MVC-COV1901 in people with COVID-19, run by Medigen Vaccine Biologics Corp. 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 11 inclusion and 21 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: finished, as of the sponsor's last update on 31 Jan 2022. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of MVC-COV1901 (time frame: Day 1 to 28 days after second vaccination). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04487210, which also lists 2 linked publications.
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 31 Jan 2022.