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A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adult (COVID-19)

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: NCT04695652
Recruitment Status : Active, not recruiting
First Posted : January 5, 2021
Last Update Posted : November 4, 2021
Sponsor:
Information provided by (Responsible Party):
Medigen Vaccine Biologics Corp.

Tracking Information
First Submitted Date  ICMJE December 31, 2020
First Posted Date  ICMJE January 5, 2021
Last Update Posted Date November 4, 2021
Actual Study Start Date  ICMJE December 30, 2020
Actual Primary Completion Date June 2, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 25, 2021)
  • Incidence of Adverse Event within 28 days post the second study intervention (Safety of MVC-COV1901) [ Time Frame: Day 1 to 28 days after second vaccination ]
    To evaluate the safety and tolerability of MVC-COV1901 from Visit 2 (Day 1) to Visit 7 (28 days after the second dose of study intervention) in terms of the number and 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 [ Time Frame: Day 1 to 28 days after second vaccination ]
    To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers
Original Primary Outcome Measures  ICMJE
 (submitted: January 4, 2021)
  • Safety of MVC-COV1901 [ Time Frame: Day 1 to 28 days after second vaccination ]
    To evaluate the safety and tolerability of MVC-COV1901 from Visit 2 (Day 1) to Visit 7 (28 days after the second dose of study intervention) in terms of the number and 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 [ Time Frame: Day 1 to 14 days after second vaccination ]
    To evaluate the immunogenicity of MVC-COV1901, as compared to placebo, in terms of neutralizing antibody titers
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2021)
  • Incidence of Adverse Event throughout study conduct (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 and percentage of participants with the occurrence of:
    • >= Grade 3 AE
    • AE of Special Interest (AESI)
    • Vaccine-Associated Enhanced Disease(VAED)
    • Serious adverse events (SAEs)
  • lot to lot consistency [ Time Frame: Day 1 to 28 days after second vaccination ]
    To evaluate the lot-to-lot consistency of MVC-COV1901 in participants of the ≥ 20 to < 65 years age group, the equivalence of the neutralizing antibody Geometric Mean Titer(GMT) among 3 different lots of MVC-COV1901
Original Secondary Outcome Measures  ICMJE
 (submitted: January 4, 2021)
  • 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 and percentage of participants with the occurrence of:
    • >= Grade 3 AE
    • AE of Special Interest (AESI)
    • Vaccine-Associated Enhanced Disease(VAED)
    • Serious adverse events (SAEs)
  • lot to lot consistency [ Time Frame: Day 1 to 28 days after second vaccination ]
    To evaluate the lot-to-lot consistency of MVC-COV1901 in participants of the ≥ 20 to < 65 years age group, the equivalence of the neutralizing antibody Geometric Mean Titer(GMT) among 3 different lots of MVC-COV1901
Current Other Pre-specified Outcome Measures
 (submitted: January 4, 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
 (submitted: January 4, 2021)
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.
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate MVC-COV1901 Vaccine Against COVID-19 in Adult
Official Title  ICMJE 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
Brief Summary The purpose of this study is to assess the safety and immunogenicity of MVC-COV1901 vaccine compared to placebo in participants who are generally healthy or with stable pre-existing health conditions.
Detailed Description This is a Phase II, prospective, placebo-controlled, double-blinded (investigator/site staff and participants), multi-center, multi-regional study; the Sponsor will be blinded until the interim analysis. Participants who are generally healthy or with stable pre-existing health conditions will be randomized, stratified by age (≥ 20 to < 65 years and ≥ 65 years of age).All eligible participants will be randomized to receive 2 doses of either MVC-COV1901 or placebo in a predefined ratio.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Condition  ICMJE Covid19 Vaccine
Intervention  ICMJE
  • Biological: MVC-COV1901(S protein with adjuvant)
    Approximately 3180 participants will receive 2 doses of MVC-COV1901(S-2P protein with adjuvant) at Visit 2 (Day 1) and Visit 4 (Day 29) via intramuscular (IM) injection in the deltoid region
  • Biological: MVC-COV1901(Saline)
    Approximately 530 participants will receive 2 doses of MVC-COV1901(Saline) at Visit 2 (Day 1) and Visit 4 (Day 29) via 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)
  • Placebo Comparator: MVC-COV1901(Saline)
    Saline/0.5 mL
    Intervention: Biological: MVC-COV1901(Saline)
Publications * Hsieh SM, Liu MC, Chen YH, Lee WS, Hwang SJ, Cheng SH, Ko WC, Hwang KP, Wang NC, Lee YL, Lin YL, Shih SR, Huang CG, Liao CC, Liang JJ, Chang CS, Chen C, Lien CE, Tai IC, Lin TY. Safety and immunogenicity of CpG 1018 and aluminium hydroxide-adjuvanted SARS-CoV-2 S-2P protein vaccine MVC-COV1901: interim results of a large-scale, double-blind, randomised, placebo-controlled phase 2 trial in Taiwan. Lancet Respir Med. 2021 Dec;9(12):1396-1406. doi: 10.1016/S2213-2600(21)00402-1. Epub 2021 Oct 13.

*   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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: November 2, 2021)
3854
Original Estimated Enrollment  ICMJE
 (submitted: January 4, 2021)
3700
Estimated Study Completion Date  ICMJE June 2022
Actual Primary Completion Date June 2, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female participant ≥ 20 to < 65 years, or ≥ 65 years of age at randomization.
  2. Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease 3 months before enrollment and expected to remain stable for the duration of the study.
  3. 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

  4. Participant is willing and able to comply with all required study visits and follow-up required by this protocol.
  5. Participant has not travelled overseas within 14 days of screening and will not have any oversea travelling throughout the study period.
  6. 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.
  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 Medical Conditions
  9. Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
  10. A history of autoimmune disease (systemic lupus, rheumatoid arthritis, scleroderma, polyarthritis, thyroiditis, Guillain-Barré syndrome, etc.).
  11. A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer (exceptions are squamous and basal cell carcinomas of the skin and treated uterine cervical carcinoma in situ, at the discretion of the investigator).
  12. Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
  13. Human immunodeficiency virus (HIV) antibody positive participants with CD4 count < 350 cells/mm3 or a detectable HIV viral load within the past year (low level variations from 50-500 viral copies/mL or equivalent which do not lead to changes in antiretroviral therapy [ART] are permitted).
  14. Hepatitis B surface antigen (HBsAg) positive participant with positive hepatitis B e antigen (HBeAg) or abnormal liver function.
  15. Hepatitis C virus (HCV) antibody positive participants with detectable HCV ribonucleic acid (RNA) viremia in recent 12 weeks.
  16. Participant with ongoing acute diseases or serious medical conditions which will interfere with adherence to study requirements, or the evaluation of any study endpoint. Acute diseases or serious medical conditions include cardiovascular (e.g. New York Heart Association Grade III or IV), pulmonary (e.g. chronic obstructive pulmonary disease stage III or IV), hepatic (e.g. Child-Pugh Class C), neurologic (e.g. dementia), metabolic (e.g. diabetes mellitus with hemoglobin A1c [HbA1c] > 8%), renal (Stage 3 or worse chronic kidney disease), psychiatric condition (e.g. alcoholism, drug abuse), current severe infections, medical history, physical findings, or laboratory abnormality that in the investigators' opinion are not in stable condition and participating in the study could adversely affect the safety of the participant.

    Medigen Vaccine Biologics Corp. 34

  17. Participant with previous known or potential exposure to SARS-CoV-1 or 2 viruses (EXCEPT for those who have been tested negative and completed the 14-day self-managements/ home quarantines/ home isolations) or received any other COVID-19 vaccine.
  18. 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.
  19. 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,   Vietnam
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04695652
Other Study ID Numbers  ICMJE CT-COV-21
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 Not Provided
Responsible Party Medigen Vaccine Biologics Corp.
Study Sponsor  ICMJE Medigen Vaccine Biologics Corp.
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 December 2020

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