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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: COVID-19 Pneumonia
• Intervention / Treatment: Biological: Covid-19 vaccine (0-1-4 schedule); Biological: Covid-19 vaccine (0-1-6 schedule)

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.

• Study Type: Interventional
• Enrollment (Anticipated): 1440
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Ruizhi ZHANG; Phone Number: +86-13985441115; Email: 919987774@qq.com

Study Locations

• China
  • Fujian
    • Quanzhou, Fujian, China
      • Nan'an Center for Disease Control and Prevention
  • Guizhou
    • Tongren, Guizhou, China
      • Songtao Miao Autonomous County Center for Disease Control and Prevention
  • Hunan
    • Zhuzhou, Hunan, China
      • You County Center for Disease Control and Prevention

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 58 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 0-1-4 schedule group; Subjects receive the booster vaccine 3 months after the second dose.	Biological: Covid-19 vaccine (0-1-4 schedule); Subjects receive the booster vaccine 3 months after the second dose.
Experimental: 0-1-6 schedule group; Subjects receive the booster vaccine 5 months after the second dose.	Biological: Covid-19 vaccine (0-1-6 schedule); Subjects receive the booster vaccine 5 months after the second dose.

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 booster dose
Neutralizing antibody level	neutralizing antibody level against coronavirus	Up to 28 days after the booster dose
Neutralizing antibody level	neutralizing antibody level against coronavirus	Up to 84 days after the booster dose
Neutralizing antibody level	neutralizing antibody level against coronavirus	Up to 168 days after the booster dose
Neutralizing antibody level	neutralizing antibody level against coronavirus	Up to 252 days after the booster dose
Neutralizing antibody level	neutralizing antibody level against coronavirus	Up to 336 days after the booster 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 after the booster dose

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Anticipated): November 1, 2021
• Primary Completion (Anticipated): November 1, 2022
• Study Completion (Anticipated): December 1, 2022

Study Registration Dates

• First Submitted: October 30, 2021
• First Submitted That Met QC Criteria: October 30, 2021
• First Posted (Actual): November 3, 2021

Study Record Updates

• Last Update Posted (Actual): November 3, 2021
• Last Update Submitted That Met QC Criteria: October 30, 2021
• Last Verified: October 1, 2021

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; Physiological Effects of Drugs; Immunologic Factors; Vaccines
• Other Study ID Numbers: COVAX BOOSTER (HT/DM)-Wuhan

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