Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

A Study to Evaluate the Safety, Tolerability, and Immunogenicity of MVC-COV1901 or MVC-COV1901(Beta) Against 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: NCT05216601
Recruitment Status : Active, not recruiting
First Posted : January 31, 2022
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, tolerability, and immunogenicity of a booster dose of vaccine in participants who are generally healthy or with stable pre-existing health conditions. Study details include:

  • The study duration per participant will be approximately 209 days (28 days screening, 1 day vaccination, and 180 days follow-up).
  • The treatment duration will be 1 day. -The visit frequency will be 6 on-site visits (1 screening visit, 1 treatment visit, and 4 follow- up visits) and 1 phone visit.

Condition or disease Intervention/treatment Phase
COVID-19 Vaccine Biological: MVC-COV1901 Biological: MVC-COV1901(Beta)-15 Biological: MVC-COV1901(Beta)-25 Phase 1

Detailed Description:
This is a Phase II, prospective, randomized, double-blinded study to evaluate the safety, tolerability, and immunogenicity of a booster vaccination with the MVC-COV1901 or MVC1901(Beta). Approximately 160 participants aged 18 years and above, who received two doses of MVC-COV1901 vaccines 84 ~ 365 days ago, will be enrolled. The participants will be stratified based on age (18 ~ < 55 years and ≥ 55 years, with a target of at least 40 participants respectively) and randomized to two treatments, MVC-COV1901 or MVC1901(Beta) in 1:1 ratio

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase I, Prospective, Randomized, Open-labeled Study to Evaluate the Safety, Tolerability, and Immunogenicity of Booster Dose With MVC-COV1901 or MVC-COV1901(Beta) SARS-CoV-2 Vaccine in Adults
Actual Study Start Date : April 22, 2022
Estimated Primary Completion Date : July 2022
Estimated Study Completion Date : January 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: MVC-COV1901
15 mcg of S-2P protein with adjuvant
Biological: MVC-COV1901
Approximately 40 participants will receive 1 doses of half of MVC-COV1901 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region

Experimental: MVC-COV1901(Beta)-15
15 mcg of S-2P protein(Beta) with adjuvant
Biological: MVC-COV1901(Beta)-15
Approximately 40 participants will receive 1 doses of half of MVC-COV1901(Beta)-15 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region

Experimental: MVC-COV1901(Beta)-25
25 mcg of S-2P protein(Beta) with adjuvant
Biological: MVC-COV1901(Beta)-25
Approximately 40 participants will receive 1 doses of half of MVC-COV1901(Beta)-25 at Visit 2 (Day 1) via intramuscular (IM) injection in the deltoid region




Primary Outcome Measures :
  1. Incidence of Adverse Events from Day 1 to 29 [ Time Frame: Day 1 to Day 29 ]

    To measure the incidence of adverse event from Day 1 to Day 28 after the booster dose.

    • Solicited local adverse events (AEs) (up to 7 days after injection of booster dose) • Solicited systemic AEs (up to 7 days after injection of booster dose)
    • Unsolicited AEs (up to 28 days after injection of booster dose)
    • AE of special interest (AESI)
    • Vaccine-associated enhanced disease (VAED) • Serious adverse event (SAE)

  2. Primary Immunogenicity-1 [ Time Frame: Day 1 to Day 29 ]

    To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29

    • GMT


  3. Primary Immunogenicity-2 [ Time Frame: Day 1 to Day 29 ]

    To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29

    • Seroconversion rate (SCR)


  4. Primary Immunogenicity-3 [ Time Frame: Day 1 to Day 29 ]

    To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29

    • GMT ratio


  5. Primary Immunogenicity-4 [ Time Frame: Day 1 to Day 29 ]

    To evaluate the immunogenicity in terms of Anti-SARS-CoV-2 neutralizing antibody at Day 29

    • Seroresponse rate



Secondary Outcome Measures :
  1. Incidence of Adverse Events from Day 1 to 181 [ Time Frame: Day 1 to Day 181 ]

    To measure the incidence of adverse event throughout the whole study period.

    • ≥ Grade 3 AE
    • AESI
    • VAED
    • SAE

  2. Secondary Immunogenicity (Humoral)-1 [ Time Frame: Day 1 to Day 181 ]

    To evaluate the immunogenicity in terms of Anti-spike IgG

    • GMT


  3. Secondary Immunogenicity (Humoral)-2 [ Time Frame: Day 1 to Day 181 ]

    To evaluate the immunogenicity in terms of Anti-spike IgG

    • SCR


  4. Secondary Immunogenicity (Humoral)-3 [ Time Frame: Day 1 to Day 181 ]

    To evaluate the immunogenicity in terms of Anti-spike IgG

    • GMT Ratio


  5. Secondary Immunogenicity (Cellular)-4 [ Time Frame: Day 1 to Day 15 ]
    To evaluate the cellular immunology by Enzyme-linked immunoSpot assay (ELISpot)

  6. Secondary Immunogenicity (Cellular)-5 [ Time Frame: Day 1 to Day 15 ]
    To evaluate the cellular immunology by Intracellular Cytokine Staining assay (ICS)


Other Outcome Measures:
  1. Exploratory Immunogenicity [ Time Frame: Day 1 to Day 29 ]

    To evaluate the immunogenicity in terms of neutralizing antibody titers against the Variants of Concern (VoCs)

    • GMT




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.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female participants ≥ 18 years and <55 years at randomization.
  2. Healthy adults or adults with pre-existing medical conditions who are in stable condition. A stable medical condition is defined as a 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. Documented to have received two or three homologous doses of MVC-COV1901 vaccine, 1st and 2nd doses within 12 weeks, 2nd and 3rd doses between 12~24 weeks (Group B only), and with the latest dose > 84 days prior to randomization, and did not receive any other investigational or approved COVID-19 vaccines.
  4. Female participants 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 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. Female with childbearing potential must have a negative pregnancy test by this protocol

  5. Participant is willing and able to comply with all required study visits and follow-up required
  6. Participant, and the participant's legal representative if applicable, must understand the procedures of the study and provide written informed consent.

Exclusion Criteria:

  1. Pregnant or breast feeding or plan to become pregnant in 30 days after the administration of study intervention.
  2. Employees at the investigator's site, of the Sponsor or delegate (e.g., contract research organization) who are directly involved in the conduct of the study.
  3. Currently receiving or received any investigational intervention within 30 days prior to the vaccination 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 vaccination of study intervention.
  5. Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the vaccination 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 vaccination 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 vaccination of study intervention.
  8. Major surgery or any radiation therapy within 12 weeks prior to the vaccination of study intervention
  9. Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
  10. 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).
  11. Bleeding disorder considered a contraindication to intramuscular injection or phlebotomy.
  12. 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, pulmonary, hepatic, neurologic, metabolic, renal, psychiatric conditions (e.g., alcoholism, drug abuse, anorexia or severe depression), current severe infections, autoimmune disease, 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.
  13. Documented SARS-CoV-1 or 2 infection prior to the study intervention.
  14. 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 MVC-COV1901 and MVC-COV1901(Beta).
  15. 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 vaccination of study intervention.
  16. Any condition that is a contraindication to study intervention based on the judgement of the investigator

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): NCT05216601


Locations
Layout table for location information
Taiwan
Taipei Medical University Hospital
Taipei, Taiwan
Tri-Service General Hospital
Taipei, Taiwan
Sponsors and Collaborators
Medigen Vaccine Biologics Corp.
Investigators
Layout table for investigator information
Study Director: Allen Lien, MD Dr.Ph Medigen Vaccine Biologics
Layout table for additonal information
Responsible Party: Medigen Vaccine Biologics Corp.
ClinicalTrials.gov Identifier: NCT05216601    
Other Study ID Numbers: CT-COV-25
First Posted: January 31, 2022    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
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.:
COVID-19 Vaccine
Additional relevant MeSH terms:
Layout table for MeSH terms
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