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

COVID-19 Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05065892
• Other study ID #: COVAX (HT/DM)-Wuhan
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: October 2021
• Est. completion date: March 2022

Study information

• Verified date: October 2021
• Source: China National Biotec Group Company Limited
• Contact: Ruizhi ZHANG
• Phone: +86-13985441115
• Email: 919987774[@]qq.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 1440
• Est. completion date: March 2022
• Est. primary completion date: January 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 60 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• COVID-19
• COVID-19 Pneumonia
• Hypertension

Intervention

Biological:
• COVAX
2 doses of Covid-19 vaccine

Locations

Country	Name	City	State
China	Nan'an Center for Disease Control and Prevention	Quanzhou	Fujian
China	Songtao Miao Autonomous County Center for Disease Control and Prevention	Tongren	Guizhou
China	You County Center for Disease Control and Prevention	Zhuzhou	Hunan

Sponsors (5)

Lead Sponsor	Collaborator
China National Biotec Group Company Limited	Fujian Center for Disease Control and Prevention, Guizhou Center for Disease Control and Prevention, Hunan 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 positive seroconversion against coronavirus	Up to 28 days after the second dose
Primary	Neutralizing antibody level	neutralizing antibody level against coronavirus	Up to 28 days after the second dose
Secondary	Adverse events following vaccination	analyse the incidence of adverse events following immunization, both solicited and unsolicited	up to 6 months