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

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ClinicalTrials.gov Identifier: NCT05075057
Recruitment Status : Recruiting
First Posted : October 12, 2021
Last Update Posted : October 22, 2021
Sponsor:
Collaborators:
Hubei Provincial Center for Disease Control and Prevention
Wuhan Institute of Biological Products Co., Ltd
Information provided by (Responsible Party):
China National Biotec Group Company Limited

Tracking Information
First Submitted Date  ICMJE October 5, 2021
First Posted Date  ICMJE October 12, 2021
Last Update Posted Date October 22, 2021
Actual Study Start Date  ICMJE October 8, 2021
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 6, 2021)
  • Seroconversion rate [ Time Frame: 28 days after the 2th dose(Day 49) ]
    The rate of seroconversion against coronavirus
  • Baseline neutralizing antibody level [ Time Frame: Before vaccination (Day 0) ]
    Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination
  • Neutralizing antibody level [ Time Frame: 28 days after the 2th dose (Day 49) ]
    Neutralizing antibody GMT against coronavirus after the 2th dose
  • Seroconversion rate [ Time Frame: 28 days after the 3th dose (Day 139) ]
    The rate of seroconversion against coronavirus after the third dose of booster immunization
  • Neutralizing antibody level [ Time Frame: Before the 3th vaccination(Day 111) ]
    Neutralizing antibody GMT against coronavirus before the 3th dose
  • Neutralizing antibody level [ Time Frame: 28 days after the 3th dose(Day 139) ]
    Neutralizing antibody GMT against coronavirus after the 3th dose
  • Neutralizing antibody level [ Time Frame: 6 months after the 3th dose (Day 291) ]
    Neutralizing antibody GMT against coronavirus after the 3th dose
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: October 6, 2021)
  • Adverse events rate [ Time Frame: 0-21/28 days following vaccinations ]
    Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
  • Serious adverse event rate [ Time Frame: 0-6 months ]
    Report and analyse serious adverse events
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and COPD
Official Title  ICMJE Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and Chronic Obstructive Pulmonary Disease
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 .
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  ICMJE Interventional
Study Phase  ICMJE Phase 4
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Intervention Model Description:
subjects aged ≥60 with chronic bronchitis and COPD receive three doses of inactivated COVID-19 vaccine
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE
  • COVID-19
  • Chronic Bronchitis
  • Copd
Intervention  ICMJE Biological: Inactivated COVID-19 vaccine
three doses of inactivated COVID-19 vaccine
Study Arms  ICMJE 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.
Intervention: Biological: Inactivated COVID-19 vaccine
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 6, 2021)
400
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE June 30, 2022
Estimated Primary Completion Date June 30, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 60 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Xianfeng Zhang (86)17702795737 hbcdczxf@163.com
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT05075057
Other Study ID Numbers  ICMJE WIBP2021COPD
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party China National Biotec Group Company Limited
Study Sponsor  ICMJE China National Biotec Group Company Limited
Collaborators  ICMJE
  • Hubei Provincial Center for Disease Control and Prevention
  • Wuhan Institute of Biological Products Co., Ltd
Investigators  ICMJE
Principal Investigator: Xianfeng Zhang Hubei Provincial Center for Disease Control and Prevention
PRS Account China National Biotec Group Company Limited
Verification Date October 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP