Back to resultsEvaluation of Immunogenicity, Safety and Antibody Persistence of COVID-19 Booster 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
Covid-19 vaccine (0-1-4 schedule)
Covid-19 vaccine (0-1-6 schedule)
Sponsored by
About this trial
This is an interventional prevention trial for COVID-19 Pneumonia
Eligibility Criteria
Inclusion Criteria:
- Participate in the clinical trial "NCT05065892".
- ≥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 Type
Experimental
Experimental
Arm Label
0-1-4 schedule group
0-1-6 schedule group
Arm Description
Subjects receive the booster vaccine 3 months after the second dose.
Subjects receive the booster vaccine 5 months after the second dose.
Outcomes
Primary Outcome Measures
Seroconversion rate
the rate of positive seroconversion against coronavirus
Neutralizing antibody level
neutralizing antibody level against coronavirus
Neutralizing antibody level
neutralizing antibody level against coronavirus
Neutralizing antibody level
neutralizing antibody level against coronavirus
Neutralizing antibody level
neutralizing antibody level 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
NCT05104437
First Posted
October 30, 2021
Last Updated
October 30, 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
NCT05104437
Brief Title
Evaluation of Immunogenicity, Safety and Antibody Persistence of COVID-19 Booster Vaccine (Produced in Wuhan) in Patients With Hypertension and/or Diabetes
Official Title
A Post-marketing Clinical Study of a Third Dose of the Inactivated SARS-CoV-2 Vaccine (Vero Cells) (Produced in Wuhan): Immunogenicity, Safety and Antibody Persistence 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
November 2021 (Anticipated)
Primary Completion Date
November 2022 (Anticipated)
Study Completion Date
December 2022 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the 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
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
To evaluate the post-marketing immunogenicity, safety and antibody persistence of the third dose (booster) of Covid-19 vaccine in patients aged 60 years or older with hypertension and/or diabetes.
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, are given a third doses of the inactivated SARS-CoV-2 vaccine (Vero cells).
These subjects are all from the "COVAX (HT/DM)-Wuhan" clinical trial (NCT05065892). 50% of them receive the booster vaccine 3 months after the second dose (0-1-4 schedule); 50% of them receive the booster vaccine 5 months after the second dose (0-1-6 schedule).
Venous blood samples are collected before the booster dose and on day 28 after the booster dose to evaluate the immunogenicity of the vaccine.
Venous blood samples are also collected on day 84/168/252/336 after the booster dose to evaluate the antibody persistence of the vaccine.
Adverse events are actively recorded on a diary card once daily from day 0 to day 7 and once from day 8 to day 21 after the booster dose. Serious adverse events (SAE) are collected within 6 months after the booster dose.
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
0-1-4 schedule group
Arm Type
Experimental
Arm Description
Subjects receive the booster vaccine 3 months after the second dose.
Arm Title
0-1-6 schedule group
Arm Type
Experimental
Arm Description
Subjects receive the booster vaccine 5 months after the second dose.
Intervention Type
Biological
Intervention Name(s)
Covid-19 vaccine (0-1-4 schedule)
Intervention Description
Subjects receive the booster vaccine 3 months after the second dose.
Intervention Type
Biological
Intervention Name(s)
Covid-19 vaccine (0-1-6 schedule)
Intervention Description
Subjects receive the booster vaccine 5 months after the second dose.
Primary Outcome Measure Information:
Title
Seroconversion rate
Description
the rate of positive seroconversion against coronavirus
Time Frame
Up to 28 days after the booster dose
Title
Neutralizing antibody level
Description
neutralizing antibody level against coronavirus
Time Frame
Up to 28 days after the booster dose
Title
Neutralizing antibody level
Description
neutralizing antibody level against coronavirus
Time Frame
Up to 84 days after the booster dose
Title
Neutralizing antibody level
Description
neutralizing antibody level against coronavirus
Time Frame
Up to 168 days after the booster dose
Title
Neutralizing antibody level
Description
neutralizing antibody level against coronavirus
Time Frame
Up to 252 days after the booster dose
Title
Neutralizing antibody level
Description
neutralizing antibody level against coronavirus
Time Frame
Up to 336 days after the booster 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 after the booster dose
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Participate in the clinical trial "NCT05065892".
≥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
Email
919987774@qq.com
Facility Information:
Facility Name
Nan'an Center for Disease Control and Prevention
City
Quanzhou
State/Province
Fujian
Country
China
Facility Name
Songtao Miao Autonomous County Center for Disease Control and Prevention
City
Tongren
State/Province
Guizhou
Country
China
Facility Name
You County Center for Disease Control and Prevention
City
Zhuzhou
State/Province
Hunan
Country
China
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Evaluation of Immunogenicity, Safety and Antibody Persistence of COVID-19 Booster Vaccine (Produced in Wuhan) in Patients With Hypertension and/or Diabetes
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