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 4-6 months, 7-9 months and \>9 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
1,848
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08) in the deltoid muscle of the upper arm
Intramuscular injection of Inactivated COVID-19 vaccine (Vero cells) in the deltoid muscle of the upper arm
Intramuscular injection of Recombinant COVID-19 Vaccine (CHO cell,NVSI-06-08) in the deltoid muscle of the upper arm on 0,30,60 days
Sheikh Khalifa Medical City
SEHA, Abu Dhab, United Arab Emirates
RECRUITINGThe 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 serverity of solicited adverse reactions
Time frame: within 0-7 days after vaccination
The incidence and severity of unsolicited adverse reactions
Time frame: within 0-7 days after vaccination
The incidence and serverity of solicited 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
GMT of subject's anti- SARS-CoV-2 neutralizing antibody
Time frame: 15th day after vaccination
GMT of subject's anti- SARS-CoV-2 neutralizing antibody
Time frame: 30th day after vaccination
Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time frame: 15th day after vaccination
Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time frame: 30th day after vaccination
Rate of GMT of subject's anti-SARS-CoV-2 IgG antibody
Time frame: before vaccination
Rate of GMT of subject's anti-SARS-CoV-2 IgG antibody
Time frame: 30th day after the full course of vaccination
Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time frame: before vaccination
Rate of 4-fold rise of anti- SARS-CoV-2 neutralizing antibody
Time frame: 30th day after the full course of vaccination
GMI of subject's anti-SARS-CoV-2 IgG antibody
Time frame: before vaccination
GMI of subject's anti-SARS-CoV-2 IgG antibody
Time frame: 30th day after the full course of 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: 30th day after the full course of vaccination
Rate of Anti-SAR-CoR-2 neutralizing antibody
only sequential clinical trial group
Time frame: the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination
Rate of GMT of IgG antibody
only sequential clinical trial group
Time frame: the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination
Rate of the titer of neutralizing antibody ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
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only sequential clinical trial group
Time frame: the 3th month, 6th month, 12th month, 18 month and 24th month after the full course of vaccination
Rate of Anti-SAR-CoR-2 neutralizing antibody
only Safety Observation Group
Time frame: the 6th month, 12th month after the full course of vaccination
Rate of GMT of IgG antibody
only Safety Observation Group
Time frame: the 6th month, 12th month after the full course of vaccination
Rate of the titer of neutralizing antibody ≥ 1: 16, ≥ 1: 32 and ≥ 1: 64
only Safety Observation Group
Time frame: the 6th month, 12th month after the full course of vaccination