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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 : Active, not recruiting
First Posted : September 17, 2021
Last Update Posted : June 14, 2022
Sponsor:
Information provided by (Responsible Party):
Medigen Vaccine Biologics Corp.

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

Condition or disease Intervention/treatment Phase
Covid19 Vaccine Biological: MVC-COV1901(S protein with adjuvant) Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 274 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
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
Actual Study Start Date : July 19, 2021
Actual Primary Completion Date : November 8, 2021
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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




Primary Outcome Measures :
  1. 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)

  2. 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)

  3. 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


Secondary Outcome Measures :
  1. 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)

  2. 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)

  3. 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


Other Outcome Measures:
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05048849


Locations
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Taiwan
Changhua Christian Hospital
Changhua, Taiwan
Kaohsiung Medical University Chung-Ho Memorial Hospital
Kaohsiung, Taiwan
China Medical University Hospital
Taichung, Taiwan
National Cheng Kung University Hospital
Tainan, Taiwan
National Taiwan University Hospital
Taipei, Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Taipei Municipal Wan Fang Hospital
Taipei, Taiwan
Taipei Veteran General Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Chang-Guang Memorial Hospital Lin-Kou
Taoyuan, Taiwan
Tao-Yuan General Hospital
Taoyuan, Taiwan
Sponsors and Collaborators
Medigen Vaccine Biologics Corp.
Investigators
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Principal Investigator: Szu-Min Hsieh, MD National Taiwan University Hospital
Principal Investigator: Tzou-Yien Lin, MD Chang Gang Memorial Hospital, LinKou
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Responsible Party: Medigen Vaccine Biologics Corp.
ClinicalTrials.gov Identifier: NCT05048849    
Other Study ID Numbers: CT-COV-21e
First Posted: September 17, 2021    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Medigen Vaccine Biologics Corp.:
Covid19 vaccine
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Somatomedin B
Trypsin Inhibitors
Serine Proteinase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action