Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes

NCT ID: NCT05065879

Last Updated: 2022-01-10

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 1440 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-05
• Study Completion Date: 2022-01-05

Brief Summary

To evaluate the post-marketing immunogenicity and safety of the inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccine (Vero cells) in patients aged 60 years or older with hypertension and/or diabetes, thus to further collect the immunogenicity and safety data of this product in special populations.

Detailed Description

After giving informed consent, patients with hypertension, patients with diabetes, patients with both diseases, and healthy controls, all aged 60 years or older, were given two doses of the inactivated SARS-CoV-2 vaccine (Vero cells). Venous blood samples were collected before the first dose and on day 28 after the second dose to evaluate the immunogenicity of the vaccine. Adverse events were actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the first dose and the second dose. Within 3 months after immunization with the second dose and collection of diary cards, the subjects were followed up by phone once a month as well as self-report to collect serious adverse events.

Conditions

COVID-19 Pneumonia

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Hypertension group

Hypertension group will enroll 330 subjects with hypertension (aged 60 years or older).

Group Type: EXPERIMENTAL

COVAX

Intervention Type: BIOLOGICAL

2 doses of Covid-19 vaccine

Diabetes group

Diabetes group will enroll 330 subjects with diabetes (aged 60 years or older).

Group Type: EXPERIMENTAL

COVAX

Intervention Type: BIOLOGICAL

2 doses of Covid-19 vaccine

Combined Diseases group

Combined Diseases group will enroll 300 subjects with both hypertension and diabetes (aged 60 years or older).

Group Type: EXPERIMENTAL

COVAX

Intervention Type: BIOLOGICAL

2 doses of Covid-19 vaccine

Healthy people group

Healthy people group will enroll 480 subjects with no medical history of hypertension or diabetes (aged 60 years or older).

Group Type: ACTIVE_COMPARATOR

COVAX

Intervention Type: BIOLOGICAL

2 doses of Covid-19 vaccine

Interventions

COVAX

2 doses of Covid-19 vaccine

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• ≥60 years old individuals with full civil capacity.
• Clinically confirmed body temperature of <37.3°C before enrolling in this study.
• Able and willing to participate in the study plan during the entire study and follow-up period.
• Capable of understanding the study procedures, willing to sign the informed consent form, and able to comply with the requirements of the clinical study protocol.

Exclusion Criteria

• Previously confirmed or asymptomatic COVID-19 patient.
• Has been immunized with a SARS-CoV-2 vaccine.
• Illiterate.
• Known allergy to any ingredient (including excipient) of this product.
• Received non-specific immunoglobulin injection within 1 month before enrollment.
• Received a live attenuated vaccine within 1 month before immunization or other vaccine within 14 days before immunization.
• Previous serious allergy to vaccine (e.g., acute allergic reaction, urticaria, angioedema, and dyspnea).
• Has uncontrolled epilepsy and other progressive neurological disorders; history of Guillain-Barré syndrome.
• Severe respiratory disorders, severe hepatic and renal diseases, malignancies, and various acute diseases or acute onset of chronic diseases.
• Diagnosed with congenital or acquired immunodeficiency, HIV infection, lymphoma, leukemia, or other autoimmune diseases.
• Definitively diagnosed with thrombocytopenia or history of other coagulation disorders that may cause subcutaneous injection to be contraindicated.
• Currently experiencing acute complications (ketoacidosis, hyperosmolar state, lactic acidosis, etc.) of diabetes; or within 2 weeks after recovery from these complications.
• Other physical conditions judged by the investigator that render the patient unsuitable for participation in the clinical study.

• Minimum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Hunan Provincial Center for Disease Control and Prevention

OTHER

Sponsor Role: collaborator

Guizhou Center for Disease Control and Prevention

OTHER

Sponsor Role: collaborator

Center for Disease Control and Prevention, Fujian

OTHER

Sponsor Role: collaborator

Beijing Institute of Biological Products Co Ltd.

INDUSTRY

Sponsor Role: collaborator

China National Biotec Group Company Limited

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Nan'an Center for Disease Control and Prevention

Quanzhou, Fujian, China

Yong'an Center for Disease Control and Prevention

Sanming, Fujian, China

Youxi Center for Disease Control and Prevention

Sanming, Fujian, China

Songtao Miao Autonomous County Center for Disease Control and Prevention

Tongren, Guizhou, China

Linli County Center for Disease Control and Prevention

Changde, Hunan, China

Countries

China

References

Huang R, Liu X, Xie F, Li J, Tang Z, Wu Y, Zhou P, Zhang D. Safety and Immunogenicity of Inactivated SARS-CoV-2 Vaccine (BBIBP-CorV) in Hypertensive and/or Diabetic People Aged over 60 Years: A Prospective Open-Label Study. Diabetes Ther. 2023 Jan;14(1):139-151. doi: 10.1007/s13300-022-01343-8. Epub 2022 Nov 27.

Reference Type: DERIVED

PMID: 36437418 (View on PubMed)

Other Identifiers

COVAX (HT/DM)-Beijing

Identifier Type: -

Identifier Source: org_study_id