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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05048849
Recruitment Status : Completed
First Posted : September 17, 2021
Last Update Posted : August 24, 2022
Sponsor:
Information provided by (Responsible Party):
Medigen Vaccine Biologics Corp.

Tracking Information
First Submitted Date  ICMJE September 3, 2021
First Posted Date  ICMJE September 17, 2021
Last Update Posted Date August 24, 2022
Actual Study Start Date  ICMJE July 19, 2021
Actual Primary Completion Date November 8, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 15, 2021)
  • 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)
  • 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)
  • 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: September 15, 2021)
  • 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)
  • 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)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: September 15, 2021)
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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety, Tolerability, and Immunogenicity of COVID-19 Vaccine, CT-COV-21 Extension Study
Official Title  ICMJE 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
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Covid19 Vaccine
Intervention  ICMJE 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
Study Arms  ICMJE Experimental: MVC-COV1901(S protein with adjuvant)
S-2P protein with CpG and Aluminum Hydroxide/0.5mL
Intervention: Biological: MVC-COV1901(S protein with adjuvant)
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 2, 2021)
274
Original Estimated Enrollment  ICMJE
 (submitted: September 15, 2021)
500
Actual Study Completion Date  ICMJE April 12, 2022
Actual Primary Completion Date November 8, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05048849
Other Study ID Numbers  ICMJE CT-COV-21e
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Medigen Vaccine Biologics Corp.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Medigen Vaccine Biologics Corp.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Szu-Min Hsieh, MD National Taiwan University Hospital
Principal Investigator: Tzou-Yien Lin, MD Chang Gang Memorial Hospital, LinKou
PRS Account Medigen Vaccine Biologics Corp.
Verification Date September 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP