Clinical trial NCT05075057: Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and COPD
Official title: Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and Chronic Obstructive Pulmonary Disease
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COVID-19
Chronic Bronchitis
Copd
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Hubei Provincial Center for Disease Control and Prevention
name: Wuhan Institute of Biological Products Co., Ltd
First posted: 2021-10-12
Enrollment: 400
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: subjects aged ≥60 with chronic bronchitis and COPD receive three doses of inactivated COVID-19 vaccine
Primary purpose: PREVENTION

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.

Eligibility 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.

Primary outcomes:
measure: Seroconversion rate
timeFrame: 28 days after the 2th dose(Day 49)
measure: Baseline neutralizing antibody level
timeFrame: Before vaccination (Day 0)
measure: Neutralizing antibody level
timeFrame: 28 days after the 2th dose (Day 49)
measure: Seroconversion rate
timeFrame: 28 days after the 3th dose (Day 139)
measure: Neutralizing antibody level
timeFrame: Before the 3th vaccination(Day 111)
measure: Neutralizing antibody level
timeFrame: 28 days after the 3th dose(Day 139)
measure: Neutralizing antibody level
timeFrame: 6 months after the 3th dose (Day 291)
Secondary outcomes:
measure: Adverse events rate
timeFrame: 0-21/28 days following vaccinations
measure: Serious adverse event rate
timeFrame: 0-6 months
Other outcomes:
Locations:
city: Wuhan
country: China
facility: Hubei Center for Disease Control and Prevention
state: Hubei
Study officials:
affiliation: Hubei Provincial Center for Disease Control and Prevention
name: Xianfeng Zhang
role: PRINCIPAL_INVESTIGATOR
References: