COVID-19Phase 4NCT05075057
Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and COPD
A Phase 4 study testing Inactivated COVID-19 vaccine in people with COVID-19 and Chronic Bronchitis, run by China National Biotec Group Company Limited at 1 site in China.
Trial 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 . Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- COVID-19, Chronic Bronchitis, Copd
- What is being tested?
- Inactivated COVID-19 vaccine
- Type of treatment
- Vaccines
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 8 Oct 2021to 30 Jun 2022
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.);
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- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Hubei Center for Disease Control and Prevention
Wuhan, Hubei
Xuhua GUAN, +86-13871244927, 552371433@qq.com
About this study
Official title: 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 .
Read the 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.
- Conditions
- COVID-19, Chronic Bronchitis, Copd
- Being tested
- Inactivated COVID-19 vaccine
- Medical subject headings
- COVID-19, Bronchitis, Chronic, Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inactivated COVID-19 vaccineBiological
three doses of inactivated COVID-19 vaccine
| Study group | Role | What they receive |
|---|---|---|
| Experimental Group | Experimental | 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. Receives: Biological: Inactivated COVID-19 vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate
The rate of seroconversion against coronavirus
Measured: 28 days after the 2th dose(Day 49)
Baseline neutralizing antibody level
Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination
Measured: Before vaccination (Day 0)
Neutralizing antibody level
Neutralizing antibody GMT against coronavirus after the 2th dose
Measured: 28 days after the 2th dose (Day 49)
Seroconversion rate
The rate of seroconversion against coronavirus after the third dose of booster immunization
Measured: 28 days after the 3th dose (Day 139)
Neutralizing antibody level
Neutralizing antibody GMT against coronavirus before the 3th dose
Measured: Before the 3th vaccination(Day 111)
Neutralizing antibody level
Neutralizing antibody GMT against coronavirus after the 3th dose
Measured: 28 days after the 3th dose(Day 139)
Neutralizing antibody level
Neutralizing antibody GMT against coronavirus after the 3th dose
Measured: 6 months after the 3th dose (Day 291)
Secondary outcomes (2)
Adverse events rate
Analyse the incidence of adverse events following vaccination, both solicited and unsolicited
Measured: 0-21/28 days following vaccinations
Serious adverse event rate
Report and analyse serious adverse events
Measured: 0-6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2021
- Study start8 Oct 2021
- Primary completion30 Jun 2022 (estimated)
- Study completion30 Jun 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- subjects aged ≥60 with chronic bronchitis and COPD receive three doses of inactivated COVID-19 vaccine
- Masking
- None (open label)
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- China National Biotec Group Company Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Hubei Provincial Center for Disease Control and Prevention, Wuhan Institute of Biological Products Co., Ltd
- Responsible party
- Sponsor
- Investigators
- Xianfeng Zhang, Principal investigator, Hubei Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05075057
- Sponsor's protocol ID
- WIBP2021COPD
- Status last verified
- Oct 2021
- First submitted
- 5 Oct 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Safety of an Inactivated COVID-19 Vaccine in Patients Aged ≥60 Years With Chronic Bronchitis and Chronic Obstructive Pulmonary Disease
- ClinicalTrials.gov ID
- NCT05075057
- Acronym / sponsor ID
- WIBP2021COPD
- Conditions
- COVID-19, Chronic Bronchitis, Copd
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- China National Biotec Group Company LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Hubei Provincial Center for Disease Control and Prevention, Wuhan Institute of Biological Products Co., Ltd
- Study start
- 8 Oct 2021 (actual)
- Primary completion
- 30 Jun 2022 (estimated)
- Study completion
- 30 Jun 2022 (estimated)
- First posted
- 12 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- subjects aged ≥60 with chronic bronchitis and COPD receive three doses of inactivated COVID-19 vaccine
| Arm | Type | Receives |
|---|---|---|
| Experimental Group | Experimental | Biological: Inactivated COVID-19 vaccineA 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. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (17 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inactivated COVID-19 vaccinethree doses of inactivated COVID-19 vaccine | Biological | Experimental Group |
Primary outcome
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
2 secondary outcomes
Adverse events rate
Time frame: 0-21/28 days following vaccinations
Serious adverse event rate
Time frame: 0-6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Oct 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xianfeng Zhang principal investigator
Hubei Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Inactivated COVID-19 vaccine in people with COVID-19 and Chronic Bronchitis, run by China National Biotec Group Company Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xianfeng Zhang ((86)17702795737, hbcdczxf@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rate (time frame: 28 days after the 2th dose(Day 49)). The study lists 7 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.