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A Heterologous 3rd COVID-19 Vaccine of MVC-COV1901 to Evaluate Immunogenicity and Safety in Adults With ChAdOx1-nCov-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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05097053
Recruitment Status : Recruiting
First Posted : October 27, 2021
Last Update Posted : December 23, 2021
Sponsor:
Collaborator:
Medigen Vaccine Biologics Corp.
Information provided by (Responsible Party):
Taoyuan General Hospital

Brief Summary:
This primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titers in adult participants in order to demonstrate the immunogenicity and safety of heterologous third-boost with MVC-COV1901, in terms of the neutralizing antibody GMTs at 28 days after the study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity by the antigen-specific immunoglobulin as well as the potential efficacy of study intervention in preventing COVID-19. This study is aimed to recruit participants at single study site in Northern Taiwan.

Condition or disease Intervention/treatment Phase
COVID-19 Vaccine Biological: MVC-COV1901(3 Months) Biological: MVC-COV1901(6 Months) Phase 4

Detailed Description:

This a parallel group, prospective, randomized, two-arm, open-label, single-center study to be conducted in approximately 200 healthy participants aged 20 to 64 years who have had their two doses of ChAdOx1-nCov-19 (Astra Zeneca). Preparation and administration of study intervention will be performed by authorized unblinded site personnel. Eligible participants will receive MVC-COV1901 vaccine after a 3-month (Group A: < 16 weeks and ≥ 12 weeks) or 6-month (Group B: < 28 weeks and ≥ 24 weeks) interval apart from their second dose of ChAdOx1-nCov-19.

The study consists of 6 on-site visits:

  • Day -28 to Day 1, Visit 1 (Screening)
  • Day 1, Visit 2 (study intervention) : randomization Group A and B

Group A:

  • Day 1, Visit 2: treatment
  • Day 29 ± 3 days, Visit 3
  • Day 85 ± 3 days, Visit 4
  • Day 169 ± 3 days, Visit 5

Group B:

  • Day 1, Visit 2
  • Day 85 ± 3 days, Visit 3: treatment
  • Day 113 ± 3 days, Visit 4
  • Day 169 ± 3 days, Visit 5

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Parallel Group, Prospective, Randomized, Two-arm, Open-label Study to Evaluate the Immunogenicity, Safety, and Tolerability of Heterologous 3rd Boost of MVC-COV1901 in Adults With 2 Doses of ChAdOx1-nCov-19 in 3 Months and 6 Months
Actual Study Start Date : October 7, 2021
Estimated Primary Completion Date : March 2022
Estimated Study Completion Date : July 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: MVC-COV1901 vaccine (3-month Interval)
There will be approximately 100 participants (Group A) who had received 2 doses of ChAdOx1-nCov-19 and will be vaccinated with MVC-COV1901 at Day 1
Biological: MVC-COV1901(3 Months)
MVC-COV1901 vaccine after a 3-month Interval

Experimental: MVC-COV1901 vaccine (6-month Interval)
There will be approximately 100 participants (Group B) who had received 2 doses of ChAdOx1-nCov-19 and will be vaccinated with MVC-COV1901 at Day 85.
Biological: MVC-COV1901(6 Months)
MVC-COV1901 vaccine after a 6-month Interval




Primary Outcome Measures :
  1. Primary Immunogenicity [ Time Frame: Day1 to 28 days after vaccination ]

    To evaluate the immunogenicity of heterologous third-boost (MVC-COV1901) in 3 months, compared to 6 months, in terms of neutralizing antibody

    Geometric Mean Titers (GMT)


  2. Primary Safety [ Time Frame: Day1 to 28 days after vaccination ]

    To evaluate the safety and tolerability of heterologous third-boost (MVC-COV1901) from Day 1 to 28 days after the study intervention

    The number and percentage of participants with the occurrence of:

    • Solicited local adverse events (AEs)
    • Solicited systemic AEs
    • Unsolicited AEs


Secondary Outcome Measures :
  1. Secondary Immunogenicity [ Time Frame: Day 1 and Day 169 ]

    To evaluate the immunogenicity of heterologous third-boost (MVC-COV1901) in terms of antigen-specific immunoglobulin titers

    GMT


  2. Secondary Safety [ Time Frame: Day 1 to Day169 ]

    To evaluate the safety of heterologous third-boost (MVC-COV1901), over the study period

    The number and percentage of participants with the occurrence of:

    • MAAEs
    • AESIs
    • VAED
    • SAEs


Other Outcome Measures:
  1. Exploratory Efficacy [ Time Frame: Day 1 to Day 169 ]

    To estimate the efficacy of heterologous third-boost (MVC COV1901), in the prevention of COVID-19

    • Number of laboratory-confirmed COVID-19 cases occurring ≥ 7 days after study intervention.
    • Number of laboratory-confirmed COVID-19 severe cases occurring ≥ 7 days after 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 to 64 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Male or female participant aged 20 to 64 years at randomization.
  2. Has received two doses of the ChAdOx1-nCov-19 (Astra-Zeneca) 12 to 16 weeks before randomization.
  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 administration 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 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 within 30 days after the last administration of study intervention.
  2. Currently receiving or received any investigational intervention within 30 days prior to the first dose of study intervention.
  3. 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.
  4. Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention.
  5. 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.
  6. 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.
  7. Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention.
  8. Has received any other investigational or licensed COVID-19 vaccine.
  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 IM injection or phlebotomy.
  12. Known SARS-CoV-2 infection in the recent 3 months prior to the first dose of study intervention.
  13. A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome.
  14. Participant who, in the investigator's judgement, is not in a stable condition and by participating in the study could adversely affect the safety of the participant, interfere with adherence to study requirements or evaluation of any study endpoint. This may include a participant with ongoing acute diseases, severe infections, autoimmune disease, laboratory abnormality or serious medical conditions in the following systems: cardiovascular, pulmonary, hepatic, neurologic, metabolic, renal, or psychiatric.
  15. 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.
  16. 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): NCT05097053


Contacts
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Contact: Chieh-Yu Cheng, MD.PhD. +886-3-3699721 ext 8311 s841060@gm.ym.edu.tw
Contact: Shu-Hsing Cheng, MD.PhD. +886-3-3699721 ext 8311 shcheng@mail.tygh.gov.tw

Locations
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Taiwan
Taoyuan General Hospital Recruiting
Taoyuan, Taiwan
Contact: Chieh-Yu Cheng, M.D., Ph.D.    +886-3-3699721 ext 8311    s841060@gm.ym.edu.tw   
Sponsors and Collaborators
Taoyuan General Hospital
Medigen Vaccine Biologics Corp.
Investigators
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Principal Investigator: Chieh-Yu Cheng, MD.PhD. Taoyuan General Hospital
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Responsible Party: Taoyuan General Hospital
ClinicalTrials.gov Identifier: NCT05097053    
Other Study ID Numbers: TYGH110044
First Posted: October 27, 2021    Key Record Dates
Last Update Posted: December 23, 2021
Last Verified: December 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 Taoyuan General Hospital:
COVID-19 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