Evaluation of immunogenicity and safety of the subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease recruited to receive the schedule of three doses of inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively .
The subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease were recruited to receive three doses of inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively. Blood samples were collected before the first dose, 28 days after the second dose, before the third dose, 28 days after the third dose and 6 months after the third dose, respectively. Any local or systemic adverse events that occurred within 21/28 days after vaccination will be recorded.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
PREVENTION
Masking
NONE
Enrollment
400
three doses of inactivated COVID-19 vaccine
Hubei Center for Disease Control and Prevention
Wuhan, Hubei, China
RECRUITINGSeroconversion rate
The rate of seroconversion against coronavirus
Time frame: 28 days after the 2th dose(Day 49)
Baseline neutralizing antibody level
Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination
Time frame: Before vaccination (Day 0)
Neutralizing antibody level
Neutralizing antibody GMT against coronavirus after the 2th dose
Time frame: 28 days after the 2th dose (Day 49)
Seroconversion rate
The rate of seroconversion against coronavirus after the third dose of booster immunization
Time frame: 28 days after the 3th dose (Day 139)
Neutralizing antibody level
Neutralizing antibody GMT against coronavirus before the 3th dose
Time frame: Before the 3th vaccination(Day 111)
Neutralizing antibody level
Neutralizing antibody GMT against coronavirus after the 3th dose
Time frame: 28 days after the 3th dose(Day 139)
Neutralizing antibody level
Neutralizing antibody GMT against coronavirus after the 3th dose
Time frame: 6 months after the 3th dose (Day 291)
Adverse events rate
Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: 0-21/28 days following vaccinations
Serious adverse event rate
Report and analyse serious adverse events
Time frame: 0-6 months