Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

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 .

Condition or disease Intervention/treatment Phase
COVID-19 Chronic Bronchitis Copd Biological: Inactivated COVID-19 vaccine Phase 4

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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
Official Title: Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and Chronic Obstructive Pulmonary Disease
Actual Study Start Date : October 8, 2021
Estimated Primary Completion Date : June 30, 2022
Estimated Study Completion Date : June 30, 2022

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Seroconversion rate [ Time Frame: 28 days after the 2th dose(Day 49) ]
    The rate of seroconversion against coronavirus

  2. Baseline neutralizing antibody level [ Time Frame: Before vaccination (Day 0) ]
    Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination

  3. Neutralizing antibody level [ Time Frame: 28 days after the 2th dose (Day 49) ]
    Neutralizing antibody GMT against coronavirus after the 2th dose

  4. 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

  5. Neutralizing antibody level [ Time Frame: Before the 3th vaccination(Day 111) ]
    Neutralizing antibody GMT against coronavirus before the 3th dose

  6. Neutralizing antibody level [ Time Frame: 28 days after the 3th dose(Day 139) ]
    Neutralizing antibody GMT against coronavirus after the 3th dose

  7. Neutralizing antibody level [ Time Frame: 6 months after the 3th dose (Day 291) ]
    Neutralizing antibody GMT against coronavirus after the 3th dose


Secondary Outcome Measures :
  1. Adverse events rate [ Time Frame: 0-21/28 days following vaccinations ]
    Analyse the incidence of adverse events following vaccination, both solicited and unsolicited

  2. Serious adverse event rate [ Time Frame: 0-6 months ]
    Report and analyse serious adverse events



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05075057


Contacts
Layout table for location contacts
Contact: Xianfeng Zhang (86)17702795737 hbcdczxf@163.com

Locations
Layout table for location information
China, Hubei
Hubei Center for Disease Control and Prevention Recruiting
Wuhan, Hubei, China
Contact: Xuhua GUAN    +86-13871244927    552371433@qq.com   
Sponsors and Collaborators
China National Biotec Group Company Limited
Hubei Provincial Center for Disease Control and Prevention
Wuhan Institute of Biological Products Co., Ltd
Investigators
Layout table for investigator information
Principal Investigator: Xianfeng Zhang Hubei Provincial Center for Disease Control and Prevention
Layout table for additonal information
Responsible Party: China National Biotec Group Company Limited
ClinicalTrials.gov Identifier: NCT05075057    
Other Study ID Numbers: WIBP2021COPD
First Posted: October 12, 2021    Key Record Dates
Last Update Posted: October 22, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
COVID-19
Bronchitis
Bronchitis, Chronic
Acute Disease
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases
Lung Diseases, Obstructive
Disease Attributes
Pathologic Processes
Pulmonary Disease, Chronic Obstructive