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

Primary Purpose

COVID-19 Pneumonia

Status

Unknown status

Phase

Phase 4

Locations

China

Study Type

Interventional

Intervention

COVAX

About this trial

This is an interventional prevention trial for COVID-19 Pneumonia

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Nan'an Center for Disease Control and Prevention
Songtao Miao Autonomous County Center for Disease Control and Prevention
You County Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Arm Label

Hypertension group

Diabetes Mellitus group

Combined Disease group

Healthy people group

Arm Description

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

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

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

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

Outcomes

Primary Outcome Measures

Seroconversion rate

the rate of positive seroconversion against coronavirus

Neutralizing antibody level

neutralizing antibody level against coronavirus

Secondary Outcome Measures

Adverse events following vaccination

analyse the incidence of adverse events following immunization, both solicited and unsolicited

Full Information

NCT ID

NCT05065892

First Posted

September 28, 2021

Last Updated

October 16, 2021

Sponsor

China National Biotec Group Company Limited

Collaborators

Guizhou Center for Disease Control and Prevention, Hunan Provincial Center for Disease Control and Prevention, Center for Disease Control and Prevention, Fujian, Wuhan Institute of Biological Products Co., Ltd

1. Study Identification

Unique Protocol Identification Number

NCT05065892

Brief Title

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

2. Study Status

Record Verification Date

October 2021

Overall Recruitment Status

Unknown status

Study Start Date

October 2021 (Anticipated)

Primary Completion Date

January 2022 (Anticipated)

Study Completion Date

March 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

China National Biotec Group Company Limited

Collaborators

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

COVID-19 Pneumonia

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Masking Description

Serum testing technicians will be masked.

Allocation

Non-Randomized

Enrollment

1440 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Hypertension group

Arm Type

Experimental

Arm Description

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

Arm Title

Diabetes Mellitus group

Arm Type

Experimental

Arm Description

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

Arm Title

Combined Disease group

Arm Type

Experimental

Arm Description

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

Arm Title

Healthy people group

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Biological

Intervention Name(s)

COVAX

Intervention Description

2 doses of Covid-19 vaccine

Primary Outcome Measure Information:

Title

Seroconversion rate

Description

the rate of positive seroconversion against coronavirus

Time Frame

Up to 28 days after the second dose

Title

Neutralizing antibody level

Description

neutralizing antibody level against coronavirus

Time Frame

Up to 28 days after the second dose

Secondary Outcome Measure Information:

Title

Adverse events following vaccination

Description

analyse the incidence of adverse events following immunization, both solicited and unsolicited

Time Frame

up to 6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Ruizhi ZHANG

Phone

+86-13985441115

919987774@qq.com

Facility Information:

Facility Name

Nan'an Center for Disease Control and Prevention

City

Quanzhou

State/Province

Fujian

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Siqun HU

Phone

+86-15880960857

Facility Name

Songtao Miao Autonomous County Center for Disease Control and Prevention

City

Tongren

State/Province

Guizhou

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Jie TAN

Phone

+86-18311709889

Facility Name

You County Center for Disease Control and Prevention

City

Zhuzhou

State/Province

Hunan

Country

China

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Zixiong LIU

Phone

+86-13974179882

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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