Trials Sponsors Conditions Drugs Pricing

Conditions

COVID-19 Vaccine

Keywords

COVID-19 Vaccine

Outcome Measures

Primary Outcomes (2)

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
Day 1 to Day 43
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: * Solicited local AEs * Solicited systemic AEs * Unsolicited AEs * Medically attended AEs (MAAEs) • AESIs * VAED * SAEs
Day 1 to Day 57

Secondary Outcomes (4)

Immunogenicity of neutralizing antibody (GMT)
Day 29 to Day 209
Immunogenicity of neutralizing antibody(SCR)
Day 29 to Day 209
Immunogenicity of neutralizing antibody(GMT ratio)
Day 29 to Day 209
Incidence of Adverse Event throughout study conduct
Day 1 to Day 209

Other Outcomes (5)

Incidence of confirmed COVID-19 cases
Day 15 to Day 209
Immunogenicity of antigen-specific immunoglobulin titers(GMT)
Day 29 to Day 209
Immunogenicity of antigen-specific immunoglobulin titers(SCR)
Day 29 to Day 209
+2 more other outcomes

Study Arms (2)

MVC-COV1901

EXPERIMENTAL

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

Biological: MVC-COV1901

AZD1222

ACTIVE COMPARATOR

ChAdOx1 nCoV-19 vaccine

Biological: AZD1222

Interventions

MVC-COV1901Biological

Approximately125 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

MVC-COV1901

AZD1222Biological

Approximately 125 participants will receive 2 doses of AZD1222 at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region

AZD1222

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersYes

Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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.

Sponsors & Collaborators

Medigen Vaccine Biologics Corp.
Industrylead

Study Sites (2)

College of Medicine and Public Health, Ubon Ratchathani University

Warin Chamrap, Changwat Ubon Ratchathani, 34190, Thailand

Sunpasitthiprasong Hospital

Ubon Ratchathani, 34000, Thailand

MeSH Terms

Interventions

MVC-COV1901 vaccineChAdOx1 nCoV-19

Intervention Hierarchy (Ancestors)

Vaccines, DNANucleic Acid-Based VaccinesVaccines, SyntheticVaccinesBiological ProductsComplex MixturesCOVID-19 VaccinesViral Vaccines

Study Officials

Allen Lien, MD. Dr.PH
Medigen Vaccine Biologics
STUDY DIRECTOR

Enrollment

250 participants (actual enrollment reported by the registry).

Study Design

Study Type: interventional
Phase: phase 3
Allocation: RANDOMIZED
Masking: TRIPLE
Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose: PREVENTION
Intervention Model: PARALLEL
Sponsor Type: INDUSTRY
Responsible Party: SPONSOR

Study Record Dates

First Submitted

January 6, 2022

First Posted

January 20, 2022

Study Start

July 30, 2022

Actual (reported)

You may not qualify if:

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 (including rapid tests).
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.
+2 more criteria

A Study to Evaluate Immunogenicity and Safety of MVC-COV1901 Compared With AZD1222 in Adults Aged 18 Years and Above

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Other Outcomes (5)

Study Arms (2)

MVC-COV1901

AZD1222

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

First Posted

Study Start

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (2)

Secondary Outcomes (4)

Other Outcomes (5)

Study Arms (2)

MVC-COV1901

AZD1222

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (2)

MeSH Terms

Interventions

Intervention Hierarchy (Ancestors)

Study Officials

Enrollment

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations