Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and COPD

NCT05075057 | Unknown Phase 4

• 1 other identifier: WIBP2021COPD
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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 three doses of inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively .

Conditions

COVID-19; Chronic Bronchitis; Copd

Outcome Measures

Primary Outcomes (7)

• 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)

• Seroconversion rate

  The rate of seroconversion against coronavirus after the third dose of booster immunization

  28 days after the 3th dose (Day 139)

• Neutralizing antibody level

  Neutralizing antibody GMT against coronavirus before the 3th dose

  Before the 3th vaccination(Day 111)

• Neutralizing antibody level

  Neutralizing antibody GMT against coronavirus after the 3th dose

  28 days after the 3th dose(Day 139)

• Neutralizing antibody level

  Neutralizing antibody GMT against coronavirus after the 3th dose

  6 months after the 3th dose (Day 291)

Secondary Outcomes (2)

• Adverse events rate

  0-21/28 days following vaccinations

• Serious adverse event rate

  0-6 months

Study Arms (1)

Experimental Group

EXPERIMENTAL

A total 400 subjects aged ≥60 years with chronic bronchitis and COPD receive three doses inactivated COVID-19 vaccine on Day 0, Day 21, Day 111, respectively.

Biological: Inactivated COVID-19 vaccine

Interventions

Inactivated COVID-19 vaccine BIOLOGICAL

three doses of inactivated COVID-19 vaccine

Experimental Group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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, angoneeurotic 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 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;

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Hubei Provincial Center for Disease Control and Prevention: collaborator
• Wuhan Institute of Biological Products Co., Ltd: collaborator

Study Sites (1)

Hubei Center for Disease Control and Prevention

Wuhan, Hubei, China

RECRUITING

MeSH Terms

Conditions

COVID-19; Bronchitis, Chronic; Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Bronchitis; Bronchial Diseases; Lung Diseases, Obstructive; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Xianfeng Zhang

  Hubei Provincial Center for Disease Control and Prevention

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Xianfeng Zhang

CONTACT

(86)17702795737; hbcdczxf@163.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: subjects aged ≥60 with chronic bronchitis and COPD receive three doses of inactivated COVID-19 vaccine

Study Record Dates

• First Submitted: October 5, 2021
• First Posted: October 12, 2021
• Study Start: October 8, 2021
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: October 22, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)