Clinical trial NCT05104216: Immunogenicity and Safety of a Third Dose and Immune Persistence of BBIBP-Corv Vaccine in Elderly People With Chronic Bronchitis and COPD
Official title: 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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COVID-19
Chronic Bronchitis
COPD
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Zhejiang Provincial Center for Disease Control and Prevention
name: Beijing Institute of Biological Products Co Ltd.
First posted: 2021-11-02
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
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.
Primary purpose: PREVENTION

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.

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;
* 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.

Primary outcomes:
measure: Seroconversion rate
timeFrame: 28 days after the 3th dose (Day 28)
measure: Neutralizing antibody level
timeFrame: Before the 3th dose (Day 0)
measure: Neutralizing antibody level
timeFrame: 28 days after the 3th dose (Day 28)
measure: Neutralizing antibody level
timeFrame: 6 months after the 3th dose
Secondary outcomes:
measure: Adverse events rate
timeFrame: 0-21days following vaccinations
measure: Serious adverse event rate
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: Zhejiang provincial center for disease control and prevention
state: Zhejiang
Study officials:
affiliation: Zhejiang Provincial Center for Disease Control and Prevention
name: Hanqing He
role: PRINCIPAL_INVESTIGATOR
References: