Clinical trial NCT05065892: Evaluation of Immunogenicity and Safety of COVID-19 Vaccine (Produced in Wuhan) in Patients With Hypertension and/or Diabetes
Official title: A Post-marketing Clinical Study of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Wuhan): Immunogenicity and Safety Assessments in Patients With Hypertension and/or Diabetes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE4
Conditions: COVID-19 Pneumonia
Lead sponsor: China National Biotec Group Company Limited
Sponsor class: INDUSTRY
Collaborators: name: Guizhou Center for Disease Control and Prevention
name: Hunan Provincial Center for Disease Control and Prevention
name: Center for Disease Control and Prevention, Fujian
name: Wuhan Institute of Biological Products Co., Ltd
First posted: 2021-10-04
Enrollment: 1440
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

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.
* 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.

Primary outcomes:
measure: Seroconversion rate
timeFrame: Up to 28 days after the second dose
measure: Neutralizing antibody level
timeFrame: Up to 28 days after the second dose
Secondary outcomes:
measure: Adverse events following vaccination
timeFrame: up to 6 months
Other outcomes:
Locations:
city: Quanzhou
country: China
facility: Nan'an Center for Disease Control and Prevention
state: Fujian
city: Tongren
country: China
facility: Songtao Miao Autonomous County Center for Disease Control and Prevention
state: Guizhou
city: Zhuzhou
country: China
facility: You County Center for Disease Control and Prevention
state: Hunan
Study officials:
References: