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

Primary Purpose

Covid19 Vaccine

Status
Completed
Phase
Phase 2
Locations
Taiwan
Study Type
Interventional
Intervention
MVC-COV1901(S protein with adjuvant)
Sponsored by
Medigen Vaccine Biologics Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Covid19 Vaccine focused on measuring Covid19 vaccine

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

MVC-COV1901(S protein with adjuvant)

Arm Description

S-2P protein with CpG and Aluminum Hydroxide/0.5mL

Outcomes

Primary Outcome Measures

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)
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)
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

Secondary Outcome Measures

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)
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)
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

Full Information

First Posted
September 3, 2021
Last Updated
August 23, 2022
Sponsor
Medigen Vaccine Biologics Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT05048849
Brief Title
A Study to Evaluate the Safety, Tolerability, and Immunogenicity of COVID-19 Vaccine, CT-COV-21 Extension 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
Study Type
Interventional

2. Study Status

Record Verification Date
September 2021
Overall Recruitment Status
Completed
Study Start Date
July 19, 2021 (Actual)
Primary Completion Date
November 8, 2021 (Actual)
Study Completion Date
April 12, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medigen Vaccine Biologics Corp.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief 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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19 Vaccine
Keywords
Covid19 vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
274 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MVC-COV1901(S protein with adjuvant)
Arm Type
Experimental
Arm Description
S-2P protein with CpG and Aluminum Hydroxide/0.5mL
Intervention Type
Biological
Intervention Name(s)
MVC-COV1901(S protein with adjuvant)
Intervention Description
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
Primary Outcome Measure Information:
Title
Number of Adverse Event (Safety of MVC-COV1901)
Description
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)
Time Frame
Day 1 to 28 days after second vaccination
Title
Percentage of Adverse Event (Safety of MVC-COV1901)
Description
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)
Time Frame
Day 1 to 28 days after second vaccination
Title
Immunogenicity of MVC-COV1901(Neutralizing Antibody)
Description
To evaluate the immunogenicity of MVC-COV1901 in terms of neutralizing antibody titers 28 days after the second dose of study intervention
Time Frame
Day 1 to 28 days after second vaccination
Secondary Outcome Measure Information:
Title
Number of Adverse Event over the study period (Secondary Safety of MVC-COV1901)
Description
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)
Time Frame
Day 1 to 180 days after second vaccination
Title
Percentage of Adverse Event over the study period (Secondary Safety of MVC-COV1901)
Description
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)
Time Frame
Day 1 to 180 days after second vaccination
Title
Immunogenicity of MVC-COV1901(Antigen-specific Immunoglobulin)
Description
To evaluate the immunogenicity of MVC-COV1901 in terms of antigen-specific immunoglobulin 28 days after the second dose of study intervention
Time Frame
Day 1 to 28 days after second vaccination
Other Pre-specified Outcome Measures:
Title
Incidence of confirmed COVID-19 cases (Efficacy of MVC-COV1901)
Description
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.
Time Frame
Day 1 to 180 days after second vaccination

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria 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: 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 Exclusion Criteria 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Szu-Min Hsieh, MD
Organizational Affiliation
National Taiwan University Hospital
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Tzou-Yien Lin, MD
Organizational Affiliation
Chang Gang Memorial Hospital, LinKou
Official's Role
Principal Investigator
Facility Information:
Facility Name
Changhua Christian Hospital
City
Changhua
Country
Taiwan
Facility Name
Kaohsiung Medical University Chung-Ho Memorial Hospital
City
Kaohsiung
Country
Taiwan
Facility Name
China Medical University Hospital
City
Taichung
Country
Taiwan
Facility Name
National Cheng Kung University Hospital
City
Tainan
Country
Taiwan
Facility Name
National Taiwan University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Medical University Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Municipal Wan Fang Hospital
City
Taipei
Country
Taiwan
Facility Name
Taipei Veteran General Hospital
City
Taipei
Country
Taiwan
Facility Name
Tri-Service General Hospital
City
Taipei
Country
Taiwan
Facility Name
Chang-Guang Memorial Hospital Lin-Kou
City
Taoyuan
Country
Taiwan
Facility Name
Tao-Yuan General Hospital
City
Taoyuan
Country
Taiwan

12. IPD Sharing Statement

Plan to Share IPD
No

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

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