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

A Post-marketing Clinical Study of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Beijing): Immunogenicity and Safety Assessments in Patients With Hypertension and/or Diabetes

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.

Study Overview

• Status: Completed
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Biological: COVAX

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 Type: Interventional
• Enrollment (Actual): 1440
• Phase: Phase 4

Contacts and Locations

Study Locations

• China
  • Fujian
    • Quanzhou, Fujian, China
      • Nan'an Center for Disease Control and Prevention
    • Sanming, Fujian, China
      • Yong'an Center for Disease Control and Prevention
    • Sanming, Fujian, China
      • Youxi Center for Disease Control and Prevention
  • Guizhou
    • Tongren, Guizhou, China
      • Songtao Miao Autonomous County Center for Disease Control and Prevention
  • Hunan
    • Changde, Hunan, China
      • Linli County Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 60 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Hypertension group; Hypertension group will enroll 330 subjects with hypertension (aged 60 years or older).	Biological: COVAX; 2 doses of Covid-19 vaccine
Experimental: Diabetes group; Diabetes group will enroll 330 subjects with diabetes (aged 60 years or older).	Biological: COVAX; 2 doses of Covid-19 vaccine
Experimental: Combined Diseases group; Combined Diseases group will enroll 300 subjects with both hypertension and diabetes (aged 60 years or older).	Biological: COVAX; 2 doses of Covid-19 vaccine
Active Comparator: Healthy people group; Healthy people group will enroll 480 subjects with no medical history of hypertension or diabetes (aged 60 years or older).	Biological: COVAX; 2 doses of Covid-19 vaccine

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Seroconversion rate	the rate of positive seroconversion against coronavirus	Up to 28 days after the second dose
Neutralizing antibody level	neutralizing antibody level against coronavirus	Up to 28 days after the second dose

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse events following vaccination	analyse the incidence of adverse events following immunization, both solicited and unsolicited	up to 6 months

Collaborators and Investigators

• Sponsor: China National Biotec Group Company Limited
• Collaborators: Beijing Institute of Biological Products Co Ltd.; Hunan Provincial Center for Disease Control and Prevention; Guizhou Center for Disease Control and Prevention; Fujian Center for Disease Control and Prevention

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2021
• Primary Completion (Actual): January 5, 2022
• Study Completion (Actual): January 5, 2022

Study Registration Dates

• First Submitted: September 28, 2021
• First Submitted That Met QC Criteria: October 1, 2021
• First Posted (Actual): October 4, 2021

Study Record Updates

• Last Update Posted (Actual): January 10, 2022
• Last Update Submitted That Met QC Criteria: January 5, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19; Hypertension
• Other Study ID Numbers: COVAX (HT/DM)-Beijing

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No