Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in Elderly People With Chronic Bronchitis and COPD

Study Overview
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Brief Summary
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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
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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.

Official Title
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Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in Elderly People With Chronic Bronchitis and Chronic Obstructive Pulmonary Disease

Conditions
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COVID-19, Chronic Bronchitis, COPD

Intervention / Treatment
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* Biological: Inactivated COVID-19 vaccine


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional 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.
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>Subjects receive a third dose of inactivated COVID-19 vaccine | Biological: Inactivated COVID-19 vaccine<br>* receive a third dose of inactivated COVID-19 vaccine<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate | The rate of seroconversion against coronavirus | 28 days after the 3th dose (Day 28) | 
| Neutralizing antibody level | Neutralizing antibody GMT against coronavirus before the 3th dose | Before the 3th dose (Day 0) | 
| Neutralizing antibody level | Neutralizing antibody GMT against coronavirus after the 3th dose | 28 days after the 3th dose (Day 28) | 
| Neutralizing antibody level | Neutralizing antibody GMT against coronavirus after the 3th dose | 6 months after the 3th dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events rate | Analyse the incidence of adverse events following vaccination, both solicited and unsolicited | 0-21days following vaccinations | 
| Serious adverse event rate | Report and analyse serious adverse events | 0-6 months |