The primary objective of the study is to evaluable the safety and to demonstrate the immunogenicity of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273), with an interval of 8-12 weeks, This study also assesses the safety and tolerability of the study intervention and explores the immunogenicity by the antigen-specific immunoglobulin, the immunogenicity against the VoCs, the antigen specific cellular immune response, as well as the potential efficacy of study intervention in preventing COVID-19.
This is a parallel group, prospective, randomized, double-blind, two-arm, single-center study to be conducted in approximately 220 healthy participants aged 20 to 70 years who are generally healthy or with stable pre-existing health condition. The participants should previously have their first dose of mRNA-1273. The participants, investigators, and the site personnel will be blinded to the study intervention assignment until all the participants complete their Day 29. Preparation and administration of 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 mRNA-1273 or MVC-COV1901 vaccine at a 1:1 ratio. Randomization of participants will be stratified by the interval apart from their first dose of mRNA-1273 (\< 10 weeks or ≥ 10 weeks). The study consists of 6 on-site visits: Day -28 to Day 1, Visit 1 (Screening) Day 1, Visit 2 (study intervention) Day 15 ± 3 days, Visit 3 Day 29 ± 3 days, Visit 4 Day 91 ± 14 days, Visit 5 Day 181 ± 14 days, Visit 6 Unscheduled visit(s) may be arranged when deemed necessary by the investigator.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
220
1st dose mRNA 1273 , 2nd dose mRNA 1273
1st dose mRNA 1273 , 2nd dose MVC COV1901
National Taiwan University Hospital
Taipei, Taiwan
Primary Immunogenicity-GMT
To evaluate the immunogenicity of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273), in terms of neutralizing antibody titers at 14 days after the study intervention -Geometric mean titer (GMT)
Time frame: Day 1 to Day 15
Primary Immunogenicity-SCR
To evaluate the immunogenicity of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273), in terms of neutralizing antibody titers at 14 days after the study intervention -Seroconversion rate (SCR)
Time frame: Day 1 to Day 15
Primary Immunogenicity-GMR
To evaluate the immunogenicity of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273), in terms of neutralizing antibody titers at 14 days after the study intervention -GMT ratio
Time frame: Day 1 to Day 15
Primary Safety
To evaluate the safety and tolerability of heterologous prime boost (mRNA 1273, MVC-COV1901), compared to homologous prime boost (mRNA 1273) from Day 1 to Day 29 The number and percentage of participants with the occurrence of: * Solicited local adverse events (AEs) * Solicited systemic AEs * Unsolicited AEs
Time frame: Day 1 to Day 29
Secondary Immunogenicity-GMT
To evaluate the immunogenicity of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273) in terms of neutralizing antibody titers at 28 days, 90 days, and 180 days after the study intervention -Geometric mean titer (GMT)
Time frame: Day 29 to Day 181
Secondary Immunogenicity-SCR
To evaluate the immunogenicity of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273) in terms of neutralizing antibody titers at 28 days, 90 days, and 180 days after the study intervention -Seroconversion rate (SCR)
Time frame: Day 29 to Day 181
Secondary Immunogenicity-GMR
To evaluate the immunogenicity of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273) in terms of neutralizing antibody titers at 28 days, 90 days, and 180 days after the study intervention -GMT ratio
Time frame: Day 29 to Day 181
Secondary Safety
To evaluate the safety of heterologous prime-boost (mRNA-1273, MVC-COV1901), compared to homologous prime-boost (mRNA-1273) throughout the study The number and percentage of participants with the occurrence of: * Medically Attended Adverse Events (MAAEs) * Adverse Event of Special Interest (AESIs) * Vaccine-Associated Enhanced Disease (VAED) * Serious Adverse Events(SAEs)
Time frame: Day 1 to Day 181
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