Clinical Trials Logo

Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT05075057
Other study ID # WIBP2021COPD
Secondary ID
Status Recruiting
Phase Phase 4
First received
Last updated
Start date October 8, 2021
Est. completion date June 30, 2022

Study information

Verified date October 2021
Source China National Biotec Group Company Limited
Contact Xianfeng Zhang
Phone (86)17702795737
Email hbcdczxf@163.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 .


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.


Recruitment information / eligibility

Status Recruiting
Enrollment 400
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender All
Age group 60 Years and older
Eligibility 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 Design


Intervention

Biological:
Inactivated COVID-19 vaccine
three doses of inactivated COVID-19 vaccine

Locations

Country Name City State
China Hubei Center for Disease Control and Prevention Wuhan Hubei

Sponsors (3)

Lead Sponsor Collaborator
China National Biotec Group Company Limited Hubei Provincial Center for Disease Control and Prevention, Wuhan Institute of Biological Products Co., Ltd

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary Seroconversion rate The rate of seroconversion against coronavirus 28 days after the 2th dose(Day 49)
Primary Baseline neutralizing antibody level Neutralizing antibody geometric mean titer(GMT) against coronavirus before vaccination Before vaccination (Day 0)
Primary Neutralizing antibody level Neutralizing antibody GMT against coronavirus after the 2th dose 28 days after the 2th dose (Day 49)
Primary Seroconversion rate The rate of seroconversion against coronavirus after the third dose of booster immunization 28 days after the 3th dose (Day 139)
Primary Neutralizing antibody level Neutralizing antibody GMT against coronavirus before the 3th dose Before the 3th vaccination(Day 111)
Primary Neutralizing antibody level Neutralizing antibody GMT against coronavirus after the 3th dose 28 days after the 3th dose(Day 139)
Primary Neutralizing antibody level Neutralizing antibody GMT against coronavirus after the 3th dose 6 months after the 3th dose (Day 291)
Secondary Adverse events rate Analyse the incidence of adverse events following vaccination, both solicited and unsolicited 0-21/28 days following vaccinations
Secondary Serious adverse event rate Report and analyse serious adverse events 0-6 months
See also
  Status Clinical Trial Phase
Withdrawn NCT06065033 - Exercise Interventions in Post-acute Sequelae of Covid-19 N/A
Completed NCT06267534 - Mindfulness-based Mobile Applications Program N/A
Completed NCT05047601 - A Study of a Potential Oral Treatment to Prevent COVID-19 in Adults Who Are Exposed to Household Member(s) With a Confirmed Symptomatic COVID-19 Infection Phase 2/Phase 3
Recruiting NCT05323760 - Functional Capacity in Patients Post Mild COVID-19 N/A
Recruiting NCT04481633 - Efficacy of Pre-exposure Treatment With Hydroxy-Chloroquine on the Risk and Severity of COVID-19 Infection N/A
Completed NCT04537949 - A Trial Investigating the Safety and Effects of One BNT162 Vaccine Against COVID-19 in Healthy Adults Phase 1/Phase 2
Completed NCT04612972 - Efficacy, Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccines (Vero Cell) to Prevent COVID-19 in Healthy Adult Population In Peru Healthy Adult Population In Peru Phase 3
Recruiting NCT05494424 - Cognitive Rehabilitation in Post-COVID-19 Condition N/A
Active, not recruiting NCT06039449 - A Study to Investigate the Prevention of COVID-19 withVYD222 in Adults With Immune Compromise and in Participants Aged 12 Years or Older Who Are at Risk of Exposure to SARS-CoV-2 Phase 3
Enrolling by invitation NCT05589376 - You and Me Healthy
Completed NCT05158816 - Extracorporal Membrane Oxygenation for Critically Ill Patients With COVID-19
Recruiting NCT04341506 - Non-contact ECG Sensor System for COVID19
Completed NCT04512079 - FREEDOM COVID-19 Anticoagulation Strategy Phase 4
Completed NCT04384445 - Zofin (Organicell Flow) for Patients With COVID-19 Phase 1/Phase 2
Completed NCT05975060 - A Study to Evaluate the Safety and Immunogenicity of an (Omicron Subvariant) COVID-19 Vaccine Booster Dose in Previously Vaccinated Participants and Unvaccinated Participants. Phase 2/Phase 3
Active, not recruiting NCT05542862 - Booster Study of SpikoGen COVID-19 Vaccine Phase 3
Terminated NCT05487040 - A Study to Measure the Amount of Study Medicine in Blood in Adult Participants With COVID-19 and Severe Kidney Disease Phase 1
Withdrawn NCT05621967 - Phonation Therapy to Improve Symptoms and Lung Physiology in Patients Referred for Pulmonary Rehabilitation N/A
Terminated NCT04498273 - COVID-19 Positive Outpatient Thrombosis Prevention in Adults Aged 40-80 Phase 3
Active, not recruiting NCT06033560 - The Effect of Non-invasive Respiratory Support on Outcome and Its Risks in Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-COV-2)-Related Hypoxemic Respiratory Failure