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

Phase 4

• Conditions: COVID-19; Chronic Bronchitis; COPD
• Interventions: Biological: Inactivated COVID-19 vaccine

• Registration Number: NCT05104216
• Lead Sponsor: China National Biotec Group Company Limited

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.

Study Timeline

• Status Verified: 2021-10
• Study First Submitted: 2021-10-21
• Study First Submitted QC: 2021-10-21
• Last Update Submitted: 2021-10-21
• Study First Posted: 2021-11-02
• Last Update Posted: 2021-11-02
• Study Start: 2021-12
• Primary Completion: 2022-06-30
• Study Completion: 2022-06-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Experimental Group	Inactivated COVID-19 vaccine	Subjects receive a third dose of inactivated COVID-19 vaccine

Primary Outcome Measures

Name	Time	Method
Seroconversion rate	28 days after the 3th dose (Day 28)	The rate of seroconversion against coronavirus
Neutralizing antibody level	6 months after the 3th dose	Neutralizing antibody GMT against coronavirus after the 3th dose

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Zhejiang provincial center for disease control and prevention; 🇨🇳 Hangzhou, Zhejiang, China