COVID-19, Chronic Bronchitis, COPD
Conditions
Brief summary
Evaluation of immunogenicity, safety and persistence of the subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease received the third dose of inactivated COVID-19 vaccine .
Detailed description
The subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease recruited to receive a third dose of inactivated COVID-19 vaccine. Blood samples will be collected 3 times: before the third dose of vaccinatioin，28 days and 6 months after the third dose of vaccination. Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.
Interventions
BIOLOGICALInactivated COVID-19 vaccine
receive a third dose of inactivated COVID-19 vaccine
Sponsors
Zhejiang Provincial Center for Disease Control and Prevention
Beijing Institute of Biological Products Co Ltd.
China National Biotec Group Company Limited
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
PREVENTION
Masking
NONE
Intervention model description
Subjects aged ≥60 with chronic bronchitis and COPD who have completed the schedule of two doses for 3 months receive a third dose of inactivated COVID-19 vaccine.
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Subjects aged 60 and above with full capacity for civil conduct; * Chronic bronchitis (or chronic obstructive pulmonary disease) diagnosed by a medical institution at level I or above; * Body temperature \< 37.3 ° C confirmed by clinical examination before enrollment ; * Able and willing to complete the entire study plan during the study follow-up period; * Have the ability to understand the study procedures, voluntarily sign informed consent, and comply with the requirements of the clinical study protocol; * Subjects participating in the past clinical trial have completed two doses of COVID-19 vaccine and blood collection before and after immunization;
Exclusion criteria
* Subjects were previously confirmed cases of COVID-19 or asymptomatic infected persons; * Being allergic to any component of vaccines (including excipients) ; * Injection of non-specific immunoglobulin within 1 month before enrollment; * Injection of live attenuated vaccines within 1 month and injection of other vaccines within 14 days before enrollment; * Subjects who have experienced severe allergic reactions to vaccines (e.g. acute anaphylaxis, urticaria, angioneurotic edema, dyspnea, etc.); * Having uncontrolled epilepsy and other progressive neurological disorders and a history of Guillain-Barre syndrome; * Having severe liver and kidney diseases, malignant tumors, acute diseases or acute episodes of chronic diseases; * Have been diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukaemia or other autoimmune diseases; * Have been diagnosed with thrombocytopenia or other clotting disorders that may contraindicate subcutaneous injection; * During an acute episode of chronic bronchitis/chronic obstructive pulmonary disease; * Subjects who had vaccine-related adverse reactions after the second dose; * Having high fever (axillary temperature ≥39.0℃) for three days after the second dose of inoculation, or severe allergic reaction; * Having any adverse nervous system reaction after the second dose; * During the acute onset of a chronic disease, or the recovery of acute complications less than two weeks; * Other reasons for exclusion considered by the investigator.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Seroconversion rate | 28 days after the 3th dose (Day 28) | The rate of seroconversion against coronavirus |
| Neutralizing antibody level | Before the 3th dose (Day 0) | Neutralizing antibody GMT against coronavirus before the 3th dose |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse events rate | 0-21days 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 |
Countries
China
Contacts
Primary ContactHanqing He
Outcome results
None listed