This is randomized, blinded and controlled design. Among the randomly selected subjects who have been vaccinated with two doses of Inactivated COVID-19 vaccine (Vero cell), based on a step-wise approach, the subjects will receive one dose of recombinant COVID-19 vaccine sequentially at different shedules of 1-3 months, 3-6 months and ≥ 6 months after two doses of vaccination, and the subjects vaccinated at different schedules will be randomly assigned to different sequential immunization groups. At the same time, each sequential immunization group will be matched with a control group with the inactivated COVID-19 vaccine (vero cells) as the booster dose.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
1,800
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell) in the deltoid muscle of the upper arm
Intramuscular injection of Recombinant COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
Sheikh Khalifa Medical City
SEHA, Abu Dhab, United Arab Emirates
GMT of anti- SARS-CoV-2 neutralizing antibody
Time frame: 14th day after vaccination
GMT of anti- SARS-CoV-2 neutralizing antibody
Time frame: 28th day after vaccination
4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time frame: 14th day after vaccination
4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time frame: 28th day after vaccination
GMT of anti- SARS-CoV-2 neutralizing antibody
Time frame: before vaccination
GMT of anti-SARS-CoV-2 IgG antibody
Time frame: 28th day after vaccination
4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time frame: before vaccination
4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time frame: 28th day after vaccination
GMI of anti-SARS-CoV-2 IgG antibody
Time frame: before vaccination
GMI of anti-SARS-CoV-2 IgG antibody
Time frame: 28th day after vaccination
Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
Time frame: before vaccination
Proportion of neutralizing antibody titer ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
Time frame: 28th day after vaccination
The incidence and serverity of any adverse reactions
Time frame: within 30 minutes after vaccination
The incidence and serverity of solicited adverse events
Time frame: within 30 minutes after vaccination
The incidence and severity of adverse reactions
Time frame: within 0-7 days after vaccination
The incidence and serverity of solicited adverse events
Time frame: within 0-7 days after vaccination
The incidence and severity of unsolicited adverse reactions
Time frame: within 8-30 days after vaccination
The incidence and serverity of solicited adverse events
Time frame: within 8-30 days after vaccination
The incidence of SAE observed
Time frame: after vaccination and up to 6 months after full course of immunization
The incidence of AESI observed
Time frame: after vaccination and up to 6 months after full course of immunization
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.