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

Phase 4

• Conditions: COVID-19 Pneumonia
• Interventions: Biological: COVAX

• Registration Number: NCT05065892
• Lead Sponsor: China National Biotec Group Company Limited

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.

Study Timeline

• Study First Submitted: 2021-09-28
• Status Verified: 2021-10
• Study Start: 2021-10
• Study First Submitted QC: 2021-10-01
• Study First Posted: 2021-10-04
• Last Update Submitted: 2021-10-16
• Last Update Posted: 2021-10-25
• Primary Completion: 2022-01
• Study Completion: 2022-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1440

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.
• Inclusion criteria for patients with hypertension and/or diabetes: Hypertension and/or diabetes definitively diagnosed by a community-level or higher medical institution. Patients with hypertension: systolic pressure <160 mmHg and diastolic pressure <100 mmHg on the day of immunization achieved by lifestyle adjustment and/or drug treatment; patients with diabetes: fasting glucose ≤13.9 mmol/L on the day of (or within 3 days before) immunization achieved by lifestyle adjustment and/or drug treatment.

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Hypertension group	COVAX	Hypertension group will enroll 330 subjects with hypertension (aged 60 years or older).
Diabetes Mellitus group	COVAX	Diabetes group will enroll 330 subjects with diabetes (aged 60 years or older).
Healthy people group	COVAX	Healthy people group will enroll 480 subjects with no medical history of hypertension or diabetes (aged 60 years or older).
Combined Disease group	COVAX	Combined Diseases group will enroll 300 subjects with both hypertension and diabetes (aged 60 years or older).

Primary Outcome Measures

Name	Time	Method
Neutralizing antibody level	Up to 28 days after the second dose	neutralizing antibody level against coronavirus
Seroconversion rate	Up to 28 days after the second dose	the rate of positive seroconversion against coronavirus

Secondary Outcome Measures

Name	Time	Method
Adverse events following vaccination	up to 6 months	analyse the incidence of adverse events following immunization, both solicited and unsolicited

Trial Locations

Locations (3)

Songtao Miao Autonomous County Center for Disease Control and Prevention; 🇨🇳 Tongren, Guizhou, China

Nan'an Center for Disease Control and Prevention; 🇨🇳 Quanzhou, Fujian, China

You County Center for Disease Control and Prevention; 🇨🇳 Zhuzhou, Hunan, China