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

NCT05011526 | Completed Phase 3 DMC

• 1 other identifier: CT-COV-31
• Study Type: interventional
• Target: 1,030
• Locations: 1 country
• Sites: 2

Brief Summary

The purpose of this study is to assess the immunogenicity and safety of MVC-COV1901 vaccine compared to AZD1222 in heathy adults.

Conditions

Covid19 Vaccine

Keywords

Covid19 Vaccine

Outcome Measures

Primary Outcomes (2)

• Immunogenicity of neutralizing antibody (GMT ratio)

  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 180 days after second vaccination

Other Outcomes (4)

• 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

Study Arms (2)

MVC-COV1901

EXPERIMENTAL

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

Biological: MVC-COV1901

AZD1222

EXPERIMENTAL

ChAdOx1 nCoV-19 vaccine

Biological: AZD1222

Interventions

MVC-COV1901 BIOLOGICAL

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

MVC-COV1901

AZD1222 BIOLOGICAL

Approximately 471 participants will receive 2 doses of AZD1222 at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region

AZD1222

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female participant aged 18 years and above at randomization.
• 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.
• Female participants:
• A female participant is eligible is the participant is a woman of non-childbearing potential, ie, surgically sterilized 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.
• 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.

You may not qualify if:

• Pregnant or breast feeding or have plan to become pregnant within 30 days after the last administration of study intervention.
• Employees at the investigator's site, of the Sponsor or delegate 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 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 study intervention.
• Administered any blood product or intravenous immunoglobulin administration within 12 weeks prior to the first dose of study intervention.
• Currently receiving or anticipate to receive concomitant immunosuppressive or immune-modifying therapy within 12 weeks prior to the first dose of study intervention.
• 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.
• Major surgery or any radiation therapy within 12 weeks prior to the first dose of study intervention.
• Has received any other investigational or approved COVID-19 vaccine.
• Immunosuppressive illness or immunodeficient state.
• A history of malignancy with potential risk for recurrence after curative treatment, or current diagnosis of or treatment for cancer.
• Bleeding disorder considered a contraindication to IM injection or phlebotomy.
• Known SARS-CoV-2 infection in the 3 months prior to the first dose of study intervention.
• A history of cerebral venous sinus thrombosis, heparin-induced thrombocytopenia or antiphospholipid 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.

Sponsors & Collaborators

• Medigen Vaccine Biologics Corp.: lead

Study Sites (2)

Hospital Fundación Tesai

Ciudad del Este, Paraguay

Location

Hospital de Clinicas - Facultad de Ciencias Médicas, Universidad Nacional de Asunción

San Lorenzo, Paraguay

Location

MeSH Terms

Interventions

MVC-COV1901 vaccine; ChAdOx1 nCoV-19

Intervention Hierarchy (Ancestors)

Vaccines, DNA; Nucleic Acid-Based Vaccines; Vaccines, Synthetic; Vaccines; Biological Products; Complex Mixtures; COVID-19 Vaccines; Viral Vaccines

Study Officials

• Luis Francisco Armoa Garcia, MD.Ph.D.

  University of Asuncion

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: August 10, 2021
• First Posted: August 18, 2021
• Study Start: October 8, 2021
• Primary Completion: December 28, 2021
• Study Completion: May 21, 2022
• Last Updated: September 30, 2022

Record last verified: 2022-08

Data Sharing

• IPD Sharing: Will not share

Locations

PA (2)