NCT05426343

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (actual)
• Sponsor: Medigen Vaccine Biologics Corp. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Accepted

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.

Conditions

• COVID-19 Vaccine

Interventions

Type	Name	Description
BIOLOGICAL	MVC-COV1901	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
BIOLOGICAL	AZD1222	Approximately 125 participants will receive 2 doses of AZD1222 at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region

Timeline

• Start date: 2022-07-09
• Primary completion: 2022-10-10
• Completion: 2023-01-07
• First posted: 2022-06-22
• Last updated: 2023-10-23

Locations

1 site across 1 country: Paraguay