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

August 23, 2022 updated by: Medigen Vaccine Biologics Corp.

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
274

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Changhua, Taiwan
        • Changhua Christian Hospital
      • Kaohsiung, Taiwan
        • Kaohsiung Medical University Chung-Ho Memorial Hospital
      • Taichung, Taiwan
        • China Medical University Hospital
      • Tainan, Taiwan
        • National Cheng Kung University Hospital
      • Taipei, Taiwan
        • Tri-Service General Hospital
      • Taipei, Taiwan
        • National Taiwan University Hospital
      • Taipei, Taiwan
        • Taipei Medical University Hospital
      • Taipei, Taiwan
        • Taipei Veteran General Hospital
      • Taipei, Taiwan
        • Taipei Municipal Wan Fang Hospital
      • Taoyuan, Taiwan
        • Chang-Guang Memorial Hospital Lin-Kou
      • Taoyuan, Taiwan
        • Tao-Yuan General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  1. 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.

  2. Female participant must:

    1. 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;
    2. 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:

    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

  3. Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
  4. Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent

Exclusion Criteria

  1. Pregnant or breast feeding or have plan to become pregnant in 30 days after last administration of study intervention.

  2. 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

  3. Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention.
  4. 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.
  5. Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention.
  6. 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.
  7. 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.
  8. Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention
  9. Participant with previous known or potential exposure to SARS-CoV-1 or 2 viruses or received any other COVID-19 vaccine.
  10. 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.
  11. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: MVC-COV1901(S protein with adjuvant)
S-2P protein with CpG and Aluminum Hydroxide/0.5mL
Biological: MVC-COV1901(S protein with adjuvant)
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Number of Adverse Event (Safety of MVC-COV1901)
Time Frame: Day 1 to 28 days after second vaccination

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)
Day 1 to 28 days after second vaccination
Percentage of Adverse Event (Safety of MVC-COV1901)
Time Frame: Day 1 to 28 days after second vaccination

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)
Day 1 to 28 days after second vaccination
Immunogenicity of MVC-COV1901(Neutralizing Antibody)
Time Frame: Day 1 to 28 days after second vaccination
To evaluate the immunogenicity of MVC-COV1901 in terms of neutralizing antibody titers 28 days after the second dose of study intervention
Day 1 to 28 days after second vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Number of Adverse Event over the study period (Secondary Safety of MVC-COV1901)
Time Frame: Day 1 to 180 days after second vaccination

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)
Day 1 to 180 days after second vaccination
Percentage of Adverse Event over the study period (Secondary Safety of MVC-COV1901)
Time Frame: Day 1 to 180 days after second vaccination

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)
Day 1 to 180 days after second vaccination
Immunogenicity of MVC-COV1901(Antigen-specific Immunoglobulin)
Time Frame: Day 1 to 28 days after second vaccination
To evaluate the immunogenicity of MVC-COV1901 in terms of antigen-specific immunoglobulin 28 days after the second dose of study intervention
Day 1 to 28 days after second vaccination

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Incidence of confirmed COVID-19 cases (Efficacy of MVC-COV1901)
Time Frame: Day 1 to 180 days after second vaccination

To estimate the efficacy of MVC-COV1901, as compared to placebo, in the prevention of COVID-19 in terms of :

  • The number of laboratory-confirmed COVID-19 cases occurring ≥ 15 days after any dose of study intervention.
  • The number of laboratory-confirmed COVID-19 severe cases occurring ≥ 15 days after any dose of study intervention.
Day 1 to 180 days after second vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Medigen Vaccine Biologics Corp.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 19, 2021

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 8, 2021

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
April 12, 2022

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
September 3, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 15, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
September 17, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2022

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2022

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CT-COV-21e

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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