The purpose of this study is to assess the immunogenicity and safety of MVC-COV1901 vaccine compared to AZD1222 in heathy adults.
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
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,030
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
Approximately 471 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
Hospital de Clinicas - Facultad de Ciencias Médicas, Universidad Nacional de Asunción
San Lorenzo, Paraguay
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
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: * Solicited local AEs * Solicited systemic AEs * Unsolicited AEs * Medically attended AEs (MAAEs) * AESIs * VAED * SAEs
Time frame: Day 1 to Day 57
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
Time frame: 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
Time frame: 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
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: * MAAEs * AESIs * VAED * SAEs
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Time frame: Day 1 to 180 days after second vaccination