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

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

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 .

Study Overview

• Status: Recruiting
• Conditions: COVID-19; COPD; Chronic Bronchitis
• Intervention / Treatment: Biological: Inactivated COVID-19 vaccine

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.

• Study Type: Interventional
• Enrollment (Anticipated): 400
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310051
      • Recruiting
      • Zhejiang Provincial Center for Disease Control and Prevention
      • Contact: Hanqing He; Phone Number: +86-571-87115170; Email: hanqinghe@cdc.zi.cn
      • Contact: Huakun Lv; Phone Number: +86-571-87115111

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	28 days after the 2th dose (Day 49)

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Beijing Institute of Biological Products Co Ltd.; Zhejiang Provincial Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): October 8, 2021
• Primary Completion (Anticipated): June 30, 2022
• Study Completion (Anticipated): June 30, 2022

Study Registration Dates

• First Submitted: October 4, 2021
• First Submitted That Met QC Criteria: October 6, 2021
• First Posted (Actual): October 12, 2021

Study Record Updates

• Last Update Posted (Actual): October 22, 2021
• Last Update Submitted That Met QC Criteria: October 20, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; Disease Attributes; Bronchial Diseases; Lung Diseases, Obstructive; Pulmonary Disease, Chronic Obstructive; COVID-19; Acute Disease; Bronchitis; Bronchitis, Chronic
• Other Study ID Numbers: BIBP2021COPD

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No