A observer-blind, randomized, controlled, investigator-initiated clinical trial to evaluate the safety and immunogenicity of a booster vaccination with Recombinant COVID-19 vaccine (Sf9 Cell) in a population aged 18-60 years old who have completed 3 doses vaccination with COVID-19 Vaccine (Vero Cell), Inactivated ≥ 6 months at least 6 months prior to enrolment. The study uses a non-inferiority design to compare between schedules with Recombinant COVID-19 Vaccine (Sf9 Cell) versus COVID-19 Vaccine (Vero Cell) Inactivated as the booster dose. Participants, laboratory and analysing statisticians will remain blind to treatment allocation. A total of 120 participants will be enrolled, participants will be randomized 1:1 to receive a single dose of Recombinant COVID-19 vaccine (Sf9 Cell) (test group) or COVID-19 Vaccine (Vero Cell), Inactivated.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
120
1dose, Intramuscular Injection
1dose, Intramuscular Injection
West China Hospital of Sichuan University
Chengdu, Sichuan, China
Incidence of adverse drug reactions (ADRs)
Time frame: Day 0-30 post-boost dose.
Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 prototype strain
Time frame: Day 30 post-boost dose.
Geometric mean titer (GMT) of specific neutralizing antibody against SARS-CoV-2 Omicron variant
Time frame: Day 30 post-boost dose.
Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 prototype strain
Time frame: Day 30 post-boost dose.
Geometric mean increase (GMI) of specific neutralizing antibody against SARS-CoV-2 Omicron variant
Time frame: Day 30 post-boost dose.
GMT and GMI of specific neutralizing antibody against SARS-CoV-2 prototype strain
Time frame: Day 7, day 14, month 3 and month 6 after the booster dose.
GMT and GMI of specific neutralizing antibody against SARS-CoV-2 omicron variant
Time frame: Day 7, day 14, month 3 and month 6 after the booster dose.
GMT and GMI of IgG antibodies against SARS-CoV-2 S protein RBD
Time frame: Day 7, day 14, day 30, month 3 and month 6 after the booster dose.
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