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

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

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

Study Overview

• Status: Completed
• Conditions: Covid19 Vaccine
• Intervention / Treatment: Biological: MVC-COV1901; Biological: AZD1222

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.

• Study Type: Interventional
• Enrollment (Actual): 1030
• Phase: Phase 3

Contacts and Locations

Study Locations

• Paraguay
  • Ciudad del Este, Paraguay
    • Hospital Fundación Tesai
  • San Lorenzo, Paraguay
    • Hospital de Clinicas - Facultad de Ciencias Médicas, Universidad Nacional de Asunción

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Immunogenicity of neutralizing antibody (GMT)	To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of neutralizing antibody titers from Day 29 to Day 209 • GMT	Day 29 to Day 209
Immunogenicity of neutralizing antibody(SCR)	To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of neutralizing antibody titers from Day 29 to Day 209 • SCR	Day 29 to Day 209
Immunogenicity of neutralizing antibody(GMT ratio)	To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of neutralizing antibody titers from Day 29 to Day 209 • GMT ratio	Day 29 to Day 209
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: MAAEs; AESIs; VAED; SAEs	Day 1 to 180 days after second vaccination

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of confirmed COVID-19 cases	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.	Day 15 to Day 209
Immunogenicity of antigen-specific immunoglobulin titers(GMT)	To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers from Day 29 to Day 209 • GMT	Day 29 to Day 209
Immunogenicity of antigen-specific immunoglobulin titers(SCR)	To evaluate the immunogenicity of MVC-COV1901 compared to AZD1222 in terms of antigen-specific immunoglobulin titers from Day 29 to Day 209 • SCR	Day 29 to Day 209
Immunogenicity of antigen-specific immunoglobulin titers(GMT ratio)	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	Day 29 to Day 209

Collaborators and Investigators

• Sponsor: Medigen Vaccine Biologics Corp.
• Investigators: Principal Investigator: Luis Francisco Armoa Garcia, MD.Ph.D., University of Asuncion

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Actual): December 28, 2021
• Study Completion (Actual): May 21, 2022

Study Registration Dates

• First Submitted: August 10, 2021
• First Submitted That Met QC Criteria: August 16, 2021
• First Posted (Actual): August 18, 2021

Study Record Updates

• Last Update Posted (Actual): September 30, 2022
• Last Update Submitted That Met QC Criteria: September 29, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: Covid19 Vaccine
• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: CT-COV-31

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No