Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Elderly People With Chronic Bronchitis and COPD

Study Overview
=================
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 two doses inactivated COVID-19 vaccine with the interval of 21 days .

Detailed Description
-----------------
The subjects aged 60 years and above with chronic bronchitis and chronic obstructive pulmonary disease were recruited to receive the schedule of two doses inactivated COVID-19 vaccine with the interval of 21 days . Blood samples will be collected 2 times: before the 1st dose of vaccinatioin and 28 days after the 2nd dose of vaccination. Any local or systemic adverse events that occurred within 21 days after vaccination will be recorded.

Official Title
-----------------
Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Elderly People With Chronic Bronchitis and Chronic Obstructive Pulmonary Disease

Conditions
-----------------
COVID-19, Chronic Bronchitis, COPD

Intervention / Treatment
-----------------
* Biological: Inactivated COVID-19 vaccine


Participation Criteria
=================
Eligibility Criteria
-----------------
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 Exclusion criteria for the first dose: Subjects were previously confirmed cases of COVID-19 or asymptomatic infected persons; Subjects have history of vaccination against COVID-19; 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; Other subjects whose physical conditions, as determined by the investigator, are not suitable for inclusion in clinical studies. Exclusion criteria for the second dose: Subjects who had vaccine-related adverse reactions after the first dose; Having high fever (axillary temperature ≥39.0℃) for three days after the first dose of inoculation, or severe allergic reaction; Having any adverse nervous system reaction after the first 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
-----------------
Minimum Age: 60 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Interventional Model Description: subjects aged ≥60 with chronic bronchitis and COPD receive two doses inactivated COVID-19 vaccine
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental Group<br>A total 400 subjects receive two doses inactivated COVID-19 vaccine with the interval of 21 days | Biological: Inactivated COVID-19 vaccine<br>* receive two doses inactivated COVID-19 vaccine with the interval of 21 days<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Seroconversion rate | The rate of seroconversion against coronavirus | 28 days after the 2th dose (Day 49) | 
| Baseline neutralizing antibody level | Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination | Before vaccination (Day 0) | 
| Neutralizing antibody level | Neutralizing antibody GMT against coronavirus after the 2th dose | 28 days after the 2th dose (Day 49) | 

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 |