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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
200
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
Approximately 125 participants will receive 2 doses of AZD1222 at Day 1 and Day 29 via intramuscular (IM) injection in the deltoid region
Hospital Fundación Tesai
Ciudad del Este, Paraguay
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
Time frame: 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 Adverse Events
Time frame: Day 1 to 28 days post the second study intervention
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
Time frame: Day 1 to Day 209
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
Time frame: Day 1 to Day 209
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
Time frame: 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 Adverse Events
Time frame: Day 1 to Day 209
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