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Covid19 VaccinePhase 2NCT05048849

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of COVID-19 Vaccine, CT-COV-21 Extension Study

A Phase 2 study testing MVC-COV1901(S protein with adjuvant) in people with Covid19 Vaccine, run by Medigen Vaccine Biologics Corp. at 11 sites 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

The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine who are generally healthy or with stable pre-existing health conditions and have received 2 doses of Placebo in the main study CT-COV-21 Read more about this study

Who is it for?
Ages 20 years and olderHealthy 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
274 participants
Where
11 sitesTaiwan
Study dates
19 Jul 2021to 12 Apr 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 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • Participants who are in the placebo arm of the main study (CT-COV-21), and are unblinded due to urgent condition other than safety events (i.e. on request from participants with high risk of acquiring and transmitting infection) after Day 119, are eligible.
  • 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
  • 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 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.
  • Prior/Concomitant Therapy
  • 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.
Show all 12Show fewer
  • 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
  • Participant with previous known or potential exposure to SARS-CoV-1 or 2 viruses 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

11 sites in 1 country.

11 sites in 1 country

Taiwan11 sites

  • Changhua Christian Hospital

    Changhua

  • Kaohsiung Medical University Chung-Ho Memorial Hospital

    Kaohsiung City

  • China Medical University Hospital

    Taichung

  • National Cheng Kung University Hospital

    Tainan

  • National Taiwan University Hospital

    Taipei

  • Taipei Medical University Hospital

    Taipei

  • Taipei Municipal Wan Fang Hospital

    Taipei

  • Taipei Veteran General Hospital

    Taipei

  • Tri-Service General Hospital

    Taipei

  • Chang-Guang Memorial Hospital Lin-Kou

    Taoyuan

  • Tao-Yuan General Hospital

    Taoyuan

Other trials in Taiwan

About this study

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

The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine who are generally healthy or with stable pre-existing health conditions and have received 2 doses of Placebo in the main study CT-COV-21

Read the detailed description

This is an extension study of the main study CT-COV-21, "A Phase II, Prospective, Double-blinded, Multi-Center, Multi-Regional Study to Evaluate the Safety, Tolerability, and Immunogenicity of the SARS-CoV-2 Vaccine Candidate MVC-COV1901."

This extension study is a prospective, open-label, multicenter study. In this extension study, approximately 500 participants who received the placebo and have remained blinded in the main study until Day 119 (90 days after the second vaccination of the main study) are enrolled and receive MVC-COV1901. Each participant will receive 2 doses of MVC-COV1901, administered 28 days apart via IM injection in the deltoid region, preferably of the non-dominant arm, at Day 1 and Day 29.

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 500 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 NCT05048849
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. Number of Adverse Event (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 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. Percentage of Adverse Event (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 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

  3. Immunogenicity of MVC-COV1901(Neutralizing Antibody)

    To evaluate the immunogenicity of MVC-COV1901 in terms of neutralizing antibody titers 28 days after the second dose of study intervention

    Measured: Day 1 to 28 days after second vaccination

Secondary outcomes (3)

  1. Number of Adverse Event over the study period (Secondary Safety of MVC-COV1901)

    To evaluate the safety of MVC-COV1901 over the study period in terms of the number 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. Percentage of Adverse Event over the study period (Secondary Safety of MVC-COV1901)

    To evaluate the safety of MVC-COV1901 over the study period in terms of the 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

  3. Immunogenicity of MVC-COV1901(Antigen-specific Immunoglobulin)

    To evaluate the immunogenicity of MVC-COV1901 in terms of antigen-specific immunoglobulin 28 days after the second dose of study intervention

    Measured: Day 1 to 28 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 posted17 Sep 2021
  2. Study start19 Jul 2021
  3. Primary completion8 Nov 2021
  4. Study completion12 Apr 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
274 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05048849
Sponsor's protocol ID
CT-COV-21e
Status last verified
Sep 2021
First submitted
3 Sep 2021
Last updated
24 Aug 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 11 sites 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 7 inclusion and 12 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 24 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 11 sites 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?

Number of Adverse Event (Safety of MVC-COV1901) (time frame: Day 1 to 28 days after second vaccination). The study lists 3 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 NCT05048849.

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 24 Aug 2022.

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