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Covid19 VaccinePhase 2NCT05038618

A Study o Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901, CT-COV-21 Sub-study

A Phase 2 study testing MVC-COV1901(S protein with adjuvant) in people with Covid19 Vaccine, run by Medigen Vaccine Biologics Corp. at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This sub-study is a prospective open-label, single-center study to demonstrate comparability of different manufacturing scales. Read more about this study

Who is it for?
Ages 20 to 64 yearsHealthy volunteers can take part
Conditions the study is for
Covid19 Vaccine
What is being tested?
MVC-COV1901(S protein with adjuvant)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
399 participants
Where
1 siteTaiwan
Study dates
2 Aug 2021to 11 Mar 2022
Phase
Phase 2
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 ≥ 20 to < 65 years, or ≥ 65 years of age at randomization.
  • Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease 3 months before enrollment and expected to remain stable for the duration of the study.
  • 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 injection of study intervention. Acceptable forms include:
  • 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
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  • Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
  • Participant has not travelled overseas within 14 days of screening and will not have any oversea travelling throughout the study period.
  • 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 in 30 days after last administration of study intervention.
  • Employees at the investigator's site, of the Sponsor or the contract research organization (CRO) directly involved in the conduct of the study.
  • 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.
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  • 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 Medical Conditions
  • Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
  • A history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, thyroiditis, Guillain-Barré syndrome, etc.).
  • 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 intramuscular injection or phlebotomy.
  • Human immunodeficiency virus (HIV) antibody positive participants with CD4 count < 350 cells/mm3 or a detectable HIV viral load within the past year (low level variations from 50-500 viral copies/mL or equivalent which do not lead to changes in antiretroviral therapy [ART] are permitted).
  • Hepatitis B surface antigen (HBsAg) positive participant with positive hepatitis B e antigen (HBeAg) or abnormal liver function.
  • Hepatitis C virus (HCV) antibody positive participants with detectable HCV ribonucleic acid (RNA) viremia in recent 12 weeks.
  • Participant with ongoing acute diseases or serious medical conditions which will interfere with adherence to study requirements, or the evaluation of any study endpoint. Acute diseases or serious medical conditions include cardiovascular (e.g. New York Heart Association Grade III or IV), pulmonary (e.g. chronic obstructive pulmonary disease stage III or IV), hepatic (e.g. Child-Pugh Class C), neurologic (e.g. dementia), metabolic (e.g. diabetes mellitus with hemoglobin A1c [HbA1c] > 8%), renal (Stage 3 or worse chronic kidney disease), psychiatric condition (e.g. alcoholism, drug abuse), current severe infections, medical history, physical findings, or laboratory abnormality that in the investigators' opinion are not in stable condition and participating in the study could adversely affect the safety of the participant.
  • Medigen Vaccine Biologics Corp. 34
  • Participant with previous known or potential exposure to SARS-CoV-1 or 2 viruses (EXCEPT for those who have been tested negative and completed the 14-day self-managements/ home quarantines/ home isolations) or received any other COVID-19 vaccine.
  • Participant 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.
  • 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

  • Chang-Guang Memorial Hospital Lin-Kou

    Taoyuan

Other trials in Taiwan

About this study

Official title: A Phase II, Prospective, Open-Label, Single-Center Study to Evaluate the Safety, Tolerability, and Immunogenicity of COVID-19 Vaccine Candidate MVC-COV1901, CT-COV-21 Sub-study

This sub-study is a prospective open-label, single-center study to demonstrate comparability of different manufacturing scales.

Read the detailed description

In this sub-study, approximately 400 adults participants who are generally healthy or with stable pre-existing health conditions aged ≥ 20 to < 65 years will be enrolled. The first 250 participants enrolled in this sub-study will receive MVC-COV1901(Scale A) and the remains will receive MVC-COV1901(Scale B). Each participant will receive 2 doses of study intervention, administered 28 days apart via IM injection in the deltoid region, preferably of the nondominant arm, at Day 1 and Day 29. The study procedure and visit schedule refer to the main study protocol and will be the same as the study procedure for the Immunogenicity Subset.

Conditions
Covid19 Vaccine
Being tested
MVC-COV1901(S protein with adjuvant)
Keywords
Covid19 vaccine

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • MVC-COV1901(S protein with adjuvant)Biological

    Approximately 400 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region

Study groups in NCT05038618
Study groupRoleWhat they receive
MVC-COV1901(S protein with adjuvant)ExperimentalS-2P protein with CpG and Aluminum Hydroxide/0.5mL
Receives: Biological: MVC-COV1901(S protein with adjuvant)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of Adverse Event within 28 days post the second study intervention (Safety of MVC-COV1901)

    To evaluate the safety and tolerability of MVC-COV1901 from Day 1 to 28 days after the second dose of study intervention in terms of the number and percentage of participants with the occurrence of:

    • Solicited local AEs (up to 7 days after each dose of study intervention)
    • Solicited systemic AEs (up to 7 days after each dose of study intervention)
    • Unsolicited AEs (up to 28 days after each dose of study intervention)
    • AE of Special Interest (AESI)
    • Vaccine-Associated Enhanced Disease(VAED)
    • Serious adverse events (SAEs)

    Measured: Day 1 to 28 days after second vaccination

  2. Immunogenicity of MVC-COV1901

    To evaluate the immunogenicity of MVC-COV1901among different manufacturing scales in terms of neutralizing antibody titers 28 days after the second vaccination

    Measured: Day 1 to 28 days after second vaccination

Secondary outcomes (2)

  1. Incidence of Adverse Event throughout study conduct (Safety of MVC-COV1901)

    To evaluate the safety of MVC-COV1901 over the study period in terms of the number and percentage of participants with the occurrence of:

    • >= Grade 3 AE
    • AE of Special Interest (AESI)
    • Vaccine-Associated Enhanced Disease(VAED)
    • Serious adverse events (SAEs)

    Measured: Day 1 to 180 days after second vaccination

  2. Immunogenicity of MVC-COV1901

    To evaluate the immunogenicity of MVC-COV1901 among different manufacturing scales in terms of antigen-specific immunoglobulin and neutralizing antibody titers 28 days after the first dose of study intervention, 14 days after the second dose of study intervention, 28 days after the second dose of study intervention and 180 days after the second dose of study intervention

    Measured: Day 1 to 180 days after second vaccination

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Sep 2021
  2. Study start2 Aug 2021
  3. Primary completion14 Oct 2021
  4. Study completion11 Mar 2022

Resources

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 2
Primary purpose
Prevention
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
399 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05038618
Sponsor's protocol ID
CT-COV-21s
Status last verified
Oct 2021
First submitted
25 Aug 2021
Last updated
13 Jun 2022
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MVC-COV1901(S protein with adjuvant) in people with Covid19 Vaccine, 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 9 inclusion and 20 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 13 Jun 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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?

Incidence of Adverse Event within 28 days post the second study intervention (Safety of MVC-COV1901) (time frame: Day 1 to 28 days after second 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?

On the ClinicalTrials.gov record for NCT05038618.

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 13 Jun 2022; AzTrials last refreshed its copy on 30 Oct 2026.

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