This is a phase I prospective, open-labeled, single-center study to evaluate the safety and immunogenicity of MVC-COV1901.
This is a phase I prospective, open-labeled, single-center study to evaluate the safety and immunogenicity of MVC-COV1901. This study is a dose escalation study with three separate arms for subjects at the age of ≥20 and \<50 years. The vaccination schedule for primary regimen consists of two doses of MVC-COV1901 for each study subject, administered by intramuscular (IM) injection 0.5mL in the deltoid region of non-dominant arm preferably 28 days apart, on Day 1 and Day 29. Subjects will receive a single booster vaccination of MVC-COV1901 on Day 209, 180 days after completion of the primary regimen.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
45
MVC-COV1901 is formulated in the different dosages of Spike (S) protein with CpG 1018 and aluminum content as adjuvant.
National Taiwan University Hospital
Taipei, Taiwan
Safety of MVC-COV1901
Incidence of solicited adverse events (AEs) after vaccination, Incidence of unsolicited AEs and other AEs after vaccination, Incidence of laboratory abnormality after vaccination, Incidence of adverse event of special interest (AESI) and serious adverse events (SAEs) after vaccination
Time frame: Day 1 to 28 days after second vaccination
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
Geometric mean titer (GMT)
Time frame: 14 days, 28 days after each vaccination, and 180 days after second vaccination.
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
Seroconversion rate (SCR)
Time frame: 14 days, 28 days after each vaccination, and 180 days after second vaccination.
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
GMT ratio
Time frame: 14 days, 28 days after each vaccination, and 180 days after second vaccination.
Immunogenicity (antigen specific cellular immune responses)
The positive rate of cellular mediated immune response
Time frame: 28 days and 180 days after second vaccination
Safety of MVC-COV1901
Incidence of other adverse events, Incidence of adverse event of special interest (AESI) and serious adverse events (SAEs) within the study period
Time frame: Day 1 to Day 209
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
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Geometric mean titer (GMT)
Time frame: 28 days and 180 days after the booster vaccination.
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
Seroconversion rate (SCR)
Time frame: 28 days and 180 days after the booster vaccination.
Immunogenicity (neutralizing antibody titers and antigen specific binding antibody titers)
GMT ratio
Time frame: 28 days and 180 days after the booster vaccination.