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A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Vaccine Compared With AZD1222

Primary Purpose

COVID-19 Vaccine

Status
Completed
Phase
Phase 3
Locations
Paraguay
Study Type
Interventional
Intervention
MVC-COV1901
AZD1222
Sponsored by
Medigen Vaccine Biologics Corp.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 Vaccine focused on measuring COVID-19 Vaccine

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. Male or female participant aged 18 years and above at randomization.
  2. Healthy adult or adult with pre-existing medical conditions who is in a 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:

    1. A female participant is eligible if the participant is a woman 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. 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. Highly effective methods of contraception include:

    i. Implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine hormonal-releasing 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 iii. Azoospermic partner (vasectomized or due to medical cause), provided the partner is the sole sexual partner of the female participant and the absence of sperm has been confirmed (from medical records/examination/history).

    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 breastfeeding or have plan to become pregnant within 30 days after the last administration of the 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 first dose of the 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 the study intervention.
  5. Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of the study intervention.
  6. Currently receiving or anticipate receiving 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 the study intervention.
  7. Currently receiving or anticipate receiving treatment with tumor necrosis factor (TNF)-α inhibitors, e.g., infliximab, adalimumab, etanercept within 12 weeks prior to the first dose of the study intervention.
  8. Major surgery or any radiation therapy within 12 weeks prior to the first dose of the study intervention.
  9. Has received any other investigational or approved COVID-19 vaccine.
  10. Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia.
  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 (IM) injection or phlebotomy.
  13. Documented SARS-CoV-2 infection prior to the first dose of study intervention, or an individual with positive anti-SARS-CoV-2 antibody test at screening.
  14. A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia, thrombosis with thrombocytopenia syndrome (TTS), antiphospholipid syndrome, or capillary leak 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. 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.
  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 (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.

Sites / Locations

  • Hospital Fundación Tesai

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

MVC-COV1901

AZD1222

Arm Description

S-2P protein with CpG and Aluminum Hydroxide/0.5mL

n=ChAdOx1 nCoV-19 vaccine

Outcomes

Primary Outcome Measures

Immunogenicity of neutralizing antibody (GMT)
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
Incidence of Adverse Event within 28 days post the second study intervention
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 Adverse Events

Secondary Outcome Measures

Immunogenicity of antigen-specific immunoglobulin (GMT)
To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers on all and elderly participants -GMT
Immunogenicity of antigen-specific immunoglobulin (SCR)
To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers on all and elderly participants -SCR
Immunogenicity of antigen-specific immunoglobulin(GMT ratio)
To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers on all and elderly participants -GMT ratio
Incidence of Adverse Event throughout study conduct
To evaluate the safety of MVC COV1901 compared to AZD1222 over the study period The number and percentage of participants with the occurrence of Adverse Events

Full Information

First Posted
June 10, 2022
Last Updated
October 20, 2023
Sponsor
Medigen Vaccine Biologics Corp.
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1. Study Identification

Unique Protocol Identification Number
NCT05426343
Brief Title
A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Vaccine Compared With AZD1222
Official Title
A Phase III, Parallel-Group, Prospective, Randomized, Double-blind, Active-controlled, Two- Arm Study to Evaluate the Immunogenicity, Safety, and Tolerability of the MVC-COV1901 Compared to AZD1222 in Adult of 18 Years and Above.
Study Type
Interventional

2. Study Status

Record Verification Date
June 2022
Overall Recruitment Status
Completed
Study Start Date
July 9, 2022 (Actual)
Primary Completion Date
October 10, 2022 (Actual)
Study Completion Date
January 7, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Medigen Vaccine Biologics Corp.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objective of the study is to measure the anti-SARS-CoV-2 neutralizing antibody titres in adult participants, in particular elderly, so as to demonstrate immunogenic superiority of MVC-COV1901 to the active control, AZD1222 vaccine, in terms of the GMT of neutralizing antibodies at 14 days after the second dose of the study intervention. This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity in terms of antigen-specific immunoglobulin as well as the potential efficacy of MVC-COV1901 in preventing COVID-19.
Detailed Description
This is a Phase III, parallel-group, prospective, randomized, double-blind, active-controlled, two- arm study to be conducted in approximately 250 participants aged 18 years and above who are generally healthy or with stable pre-existing medical conditions. The participants, investigators, the site personnel and the Sponsor staff who are involved in the blinded conduct of the study will be blinded to the study intervention assignment. Preparation and administration of the study intervention will be performed by authorized unblinded site personnel who do not participate in the evaluation of the participants. Eligible participants will be randomized to receive either MVC-COV1901 or AZD1222 vaccine in a 1:1 ratio. Randomization of participants will be stratified by study site and age (≥ 18 to < 65 years and ≥ 65 years), at least 40% of the participants shall be ≥ 65 years. Approximately 30 participants in the age 18 to <65 group and 10 participants in the age ≥ 65 years will be included in the CMI Subset for CMI assessments.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19 Vaccine
Keywords
COVID-19 Vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Actual)

8. Arms, Groups, and Interventions

Arm Title
MVC-COV1901
Arm Type
Experimental
Arm Description
S-2P protein with CpG and Aluminum Hydroxide/0.5mL
Arm Title
AZD1222
Arm Type
Active Comparator
Arm Description
n=ChAdOx1 nCoV-19 vaccine
Intervention Type
Biological
Intervention Name(s)
MVC-COV1901
Intervention Description
Approximately 125 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
Intervention Type
Biological
Intervention Name(s)
AZD1222
Intervention Description
Approximately 125 participants will receive 2 doses of AZD1222 at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region
Primary Outcome Measure Information:
Title
Immunogenicity of neutralizing antibody (GMT)
Description
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
Time Frame
Day 1 to Day 43
Title
Incidence of Adverse Event within 28 days post the second study intervention
Description
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 Adverse Events
Time Frame
Day 1 to 28 days post the second study intervention
Secondary Outcome Measure Information:
Title
Immunogenicity of antigen-specific immunoglobulin (GMT)
Description
To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers on all and elderly participants -GMT
Time Frame
Day 1 to Day 209
Title
Immunogenicity of antigen-specific immunoglobulin (SCR)
Description
To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers on all and elderly participants -SCR
Time Frame
Day 1 to Day 209
Title
Immunogenicity of antigen-specific immunoglobulin(GMT ratio)
Description
To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers on all and elderly participants -GMT ratio
Time Frame
Day 29 to Day 209
Title
Incidence of Adverse Event throughout study conduct
Description
To evaluate the safety of MVC COV1901 compared to AZD1222 over the study period The number and percentage of participants with the occurrence of Adverse Events
Time Frame
Day 1 to Day 209
Other Pre-specified Outcome Measures:
Title
Incidence of confirmed COVID-19 cases
Description
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.
Time Frame
Day 43 to Day 209
Title
Cell Mediated Immunity
Description
To assess cell-mediated immune response of MVC-COV1901compared to AZD1222 Change from Baseline in IFN-gamma expression
Time Frame
Day 1 to Day 43

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Male or female participant aged 18 years and above at randomization. Healthy adult or adult with pre-existing medical conditions who is in a 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. Female participant: A female participant is eligible if the participant is a woman 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. 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. Highly effective methods of contraception include: i. Implanted hormonal methods of contraception or placement of an intrauterine device or intrauterine hormonal-releasing 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 iii. Azoospermic partner (vasectomized or due to medical cause), provided the partner is the sole sexual partner of the female participant and the absence of sperm has been confirmed (from medical records/examination/history). c. Have a negative pregnancy test Participant is willing and able to comply with all required study visits and follow-up required by this protocol. Participant or the participant's legal representative must understand the procedures of the study and provide written informed consent. Exclusion Criteria: Pregnant or breastfeeding or have plan to become pregnant within 30 days after the last administration of the study intervention. 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 Currently receiving or received any investigational intervention within 30 days prior to the first dose of the study intervention. 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 the study intervention. Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of the study intervention. Currently receiving or anticipate receiving 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 the study intervention. Currently receiving or anticipate receiving treatment with tumor necrosis factor (TNF)-α inhibitors, e.g., infliximab, adalimumab, etanercept within 12 weeks prior to the first dose of the study intervention. Major surgery or any radiation therapy within 12 weeks prior to the first dose of the study intervention. Has received any other investigational or approved COVID-19 vaccine. Immunosuppressive illness or immunodeficient state, including hematologic malignancy, history of solid organ, bone marrow transplantation, or asplenia. 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). Bleeding disorder considered a contraindication to intramuscular (IM) injection or phlebotomy. Documented SARS-CoV-2 infection prior to the first dose of study intervention, or an individual with positive anti-SARS-CoV-2 antibody test at screening. A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia, thrombosis with thrombocytopenia syndrome (TTS), antiphospholipid syndrome, or capillary leak syndrome. 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. 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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allen Lien, MD. Dr.PH
Organizational Affiliation
Medigen Vaccine Biologics
Official's Role
Study Director
Facility Information:
Facility Name
Hospital Fundación Tesai
City
Ciudad del Este
Country
Paraguay

12. IPD Sharing Statement

Plan to Share IPD
No

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A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Vaccine Compared With AZD1222

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