This is a randomized, phase Ⅱ, single-blind, randomized, parallel-group controlled clinical trial. The study plans to enroll subjects who have completed homologous primary vaccination with either inactivated or mRNA or Viral Vector COVID-19 vaccines (one or two doses) and have not been infected with COVID-19. All subjects will be evaluated for safety and immunogenicity after a single dose booster immunization with Recombinant COVID-19 variant Vaccine (Sf9 Cell) or inactivated COVID-19 vaccine (Vero cell) or mRNA vaccine or Viral Vector vaccine.
This is a randomized, phase Ⅱ, single-blind, randomized, parallel-group controlled clinical trial. The study plans to enroll subjects who have completed homologous primary vaccination with either inactivated or mRNA or Viral Vector COVID-19 vaccines (one or two doses) and have not been infected with COVID-19. All subjects will be evaluated for safety and immunogenicity after a single dose booster immunization with Recombinant COVID-19 variant Vaccine (Sf9 Cell) or inactivated COVID-19 vaccine (Vero cell) or mRNA vaccine or Viral Vector vaccine. The study plans to enroll about 600 subjects aged 18 years and above (subjects aged ≥ 60 years account for approximately 10%) that would be divided into three cohorts according to different primary vaccination: Inactivated COVID-19 vaccines cohort, mRNA COVID-19 vaccines cohort and Viral Vector COVID-19 vaccines cohort, with approximately 200 cases in each cohort. The subjects will be randomized to the Recombinant COVID-19 variant Vaccine (Sf9 Cell) group (test group) or the inactivated COVID-19 vaccine (Vero cell) group or mRNA vaccine or Viral Vector vaccine (control group) in a ratio of 1:1.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
1dose, Intramuscular Injection
1dose, Intramuscular Injection
1dose, Intramuscular Injection
Clínica de Enfermedades Crónicas y de Procedimientos Especiales, S.C.
Morelia, Michoacán, Mexico
Incidence of adverse drug reactions (ADRs)
Time frame: Day 0-28 post-boost dose
GMT and SCR of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2
Time frame: Day 14 post-boost dose
Incidence of adverse events (AEs)
Time frame: Day 0-7 post-boost dose
Incidence of AEs
Time frame: Day 0-28 post-boost dose
Incidence of serious adverse events (SAEs)
Time frame: Day 0 through 6 months post-boost dose
GMT and SCR of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2
Time frame: Day 28, month 3 and month 6 post-boost dose
GMI of specific neutralizing antibody (virus or pseudovirus) against SARS-CoV-2
Time frame: Day 14, Day 28, month 3 and month 6 post-boost dose
GMT, GMI and SCR of IgG antibodies against Vac2107 of SARS-CoV-2
Time frame: Day 14, Day 28, month 3 and month 6 post-boost dose
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1dose, Intramuscular Injection