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A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 Against COVID-19 in Adults

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: NCT05011526
Recruitment Status : Active, not recruiting
First Posted : August 18, 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 immunogenicity and safety of MVC-COV1901 vaccine compared to AZD1222 in heathy adults.

Condition or disease Intervention/treatment Phase
Covid19 Vaccine Biological: MVC-COV1901 Biological: AZD1222 Phase 3

Detailed Description:
The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titers in adult participants so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT ratio of neutralizing antibodies at 14 days after the second dose of study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity in terms of anti-S IgG as well as the potential efficacy of MVC-COV1901 in preventing COVID-19.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1020 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Phase III, Parallel Group, Prospective, Randomized, Double-blind, Active-controlled, Two-arm, Multi-center Study to Evaluate the Immunogenicity, Safety, and Tolerability of MVC-COV1901 Compared to AZD1222 in Adults of 18 Years and Above
Actual Study Start Date : October 8, 2021
Actual Primary Completion Date : December 28, 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine

Drug Information available for: AZD-1222

Arm Intervention/treatment
Experimental: MVC-COV1901
S-2P protein with CpG and Aluminum Hydroxide/0.5mL
Biological: MVC-COV1901
Approximately 471 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

Experimental: AZD1222
ChAdOx1 nCoV-19 vaccine
Biological: AZD1222
Approximately 471 participants will receive 2 doses of AZD1222 at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region




Primary Outcome Measures :
  1. Immunogenicity of neutralizing antibody (GMT ratio) [ Time Frame: Day 1 to Day 43 ]

    To demonstrate the immunogenic superiority of MVC-COV1901 to AZD1222 in terms of neutralizing antibody titers at 14 days after the second vaccination

    -GMT ratio


  2. Incidence of Adverse Event within 28 days post the second study intervention [ Time Frame: Day 1 to Day 57 ]

    To evaluate the safety and tolerability of MVC-COV1901 compared to AZD1222 from Day 1 to 28 days after the second vaccination

    The number and percentage of participants with the occurrence of:

    • Solicited local AEs
    • Solicited systemic AEs
    • Unsolicited AEs
    • Medically attended AEs (MAAEs)
    • AESIs
    • VAED
    • SAEs


Secondary Outcome Measures :
  1. Immunogenicity of neutralizing antibody (GMT) [ Time Frame: Day 29 to Day 209 ]

    To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of neutralizing antibody titers from Day 29 to Day 209

    • GMT


  2. Immunogenicity of neutralizing antibody(SCR) [ Time Frame: Day 29 to Day 209 ]

    To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of neutralizing antibody titers from Day 29 to Day 209

    • SCR


  3. Immunogenicity of neutralizing antibody(GMT ratio) [ Time Frame: Day 29 to Day 209 ]

    To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of neutralizing antibody titers from Day 29 to Day 209

    • GMT ratio


  4. Incidence of Adverse Event throughout study conduct [ Time Frame: Day 1 to 180 days after second vaccination ]

    To evaluate the safety of MVC COV1901 compared to AZD1222 over the study period

    The number and percentage of participants with the occurrence of:

    • MAAEs
    • AESIs
    • VAED
    • SAEs


Other Outcome Measures:
  1. Incidence of confirmed COVID-19 cases [ Time Frame: Day 15 to Day 209 ]

    To estimate the efficacy of MVC-COV1901, as compared to AZD1222, 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.

  2. Immunogenicity of antigen-specific immunoglobulin titers(GMT) [ Time Frame: Day 29 to Day 209 ]

    To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers from Day 29 to Day 209

    • GMT


  3. Immunogenicity of antigen-specific immunoglobulin titers(SCR) [ Time Frame: Day 29 to Day 209 ]

    To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers from Day 29 to Day 209

    • SCR


  4. Immunogenicity of antigen-specific immunoglobulin titers(GMT ratio) [ Time Frame: Day 29 to Day 209 ]

    To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers from Day 29 to Day 209

    • GMT ratio




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

Inclusion Criteria:

  1. Male or female participant aged 18 years and above 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 participants:

    1. A female participant is eligible is the participant is a woman of non-childbearing potential, ie, surgically sterilized or one year post-menopausal.
    2. If the participant is a woman of childbearing potential, she must agree to practice sexual abstinence or agree to use medically effective contraception from 14 days before screening to 30 days following the last administration of study intervention.
    3. 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. Employees at the investigator's site, of the Sponsor or delegate who are 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 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 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. Has received any other investigational or approved COVID-19 vaccine.
  10. Immunosuppressive illness or immunodeficient state.
  11. A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer.
  12. Bleeding disorder considered a contraindication to IM injection or phlebotomy.
  13. Known SARS-CoV-2 infection in the 3 months prior to the first dose of study intervention.
  14. A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid syndrome.
  15. 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.
  16. 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 or AZD1222.
  17. Body (oral, rectal, or ear) temperature ≥ 38.0°C or acute illness 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): NCT05011526


Locations
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Paraguay
Hospital Fundación Tesai
Ciudad del Este, Paraguay
Hospital de Clinicas - Facultad de Ciencias Médicas, Universidad Nacional de Asunción
San Lorenzo, Paraguay
Sponsors and Collaborators
Medigen Vaccine Biologics Corp.
Investigators
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Principal Investigator: Luis Francisco Armoa Garcia, MD.Ph.D. University of Asuncion
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Responsible Party: Medigen Vaccine Biologics Corp.
ClinicalTrials.gov Identifier: NCT05011526    
Other Study ID Numbers: CT-COV-31
First Posted: August 18, 2021    Key Record Dates
Last Update Posted: June 14, 2022
Last Verified: August 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