Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and COPD
- Conditions
- CopdCOVID-19Chronic Bronchitis
- Interventions
- Biological: Inactivated COVID-19 vaccine
- Registration Number
- NCT05075057
- Lead Sponsor
- China National Biotec Group Company Limited
- Brief Summary
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 .
- Detailed Description
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.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 400
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Experimental Group Inactivated COVID-19 vaccine A total 400 subjects aged ≥60 years with chronic bronchitis and COPD receive three doses inactivated COVID-19 vaccine on Day 0, Day 21, Day 111, respectively.
- Primary Outcome Measures
Name Time Method Seroconversion rate 28 days after the 3th dose (Day 139) The rate of seroconversion against coronavirus after the third dose of booster immunization
Neutralizing antibody level 6 months after the 3th dose (Day 291) Neutralizing antibody GMT against coronavirus after the 3th dose
Baseline neutralizing antibody level Before vaccination (Day 0) Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination
- Secondary Outcome Measures
Name Time Method Adverse events rate 0-21/28 days following vaccinations Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
Serious adverse event rate 0-6 months Report and analyse serious adverse events
Trial Locations
- Locations (1)
Hubei Center for Disease Control and Prevention
🇨🇳Wuhan, Hubei, China