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

Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years 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 three doses of inactivated COVID-19 vaccine on day 0, day 21 and day 111, respectively .

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

Blood samples were collected before the first dose, 28 days after the second dose, before the third dose, 28 days after the third dose and 6 months after the third dose, respectively.

Any local or systemic adverse events that occurred within 21/28 days after vaccination will be recorded.

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

Contacts and Locations

• Study Contact: Name: Xianfeng Zhang; Phone Number: (86)17702795737; Email: hbcdczxf@163.com

Study Locations

• China
  • Hubei
    • Wuhan, Hubei, China
      • Recruiting
      • Hubei Center for Disease Control and Prevention
      • Contact: Xuhua GUAN; Phone Number: +86-13871244927; Email: 552371433@qq.com

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, 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;
• 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 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; three doses of inactivated COVID-19 vaccine

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)
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events rate	Analyse the incidence of adverse events following vaccination, both solicited and unsolicited	0-21/28 days following vaccinations
Serious adverse event rate	Report and analyse serious adverse events	0-6 months

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Wuhan Institute of Biological Products Co., Ltd; Hubei Provincial Center for Disease Control and Prevention
• Investigators: Principal Investigator: Xianfeng Zhang, Hubei 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 5, 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: WIBP2021COPD

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