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

NCT05104333 | Unknown Phase 4

• 1 other identifier: COVAX BOOSTER (HT/DM)-Beijing
• Study Type: interventional
• Target: 1,440
• Locations: 1 country
• Sites: 5

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.

Conditions

COVID-19 Pneumonia

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (1)

• Adverse events following vaccination

  Up to 6 months after the booster dose

Study Arms (2)

0-1-4 schedule group

EXPERIMENTAL

Subjects receive the booster vaccine 3 months after the second dose.

Biological: Covid-19 vaccine (0-1-4 schedule)

0-1-6 schedule group

EXPERIMENTAL

Subjects receive the booster vaccine 5 months after the second dose.

Biological: Covid-19 vaccine (0-1-6 schedule)

Interventions

Covid-19 vaccine (0-1-4 schedule) BIOLOGICAL

Subjects receive the booster vaccine 3 months after the second dose.

0-1-4 schedule group

Covid-19 vaccine (0-1-6 schedule) BIOLOGICAL

Subjects receive the booster vaccine 5 months after the second dose.

0-1-6 schedule group

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participate in the clinical trial "NCT05065879".
• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• China National Biotec Group Company Limited: lead
• Guizhou Center for Disease Control and Prevention: collaborator
• Hunan Provincial Center for Disease Control and Prevention: collaborator
• Center for Disease Control and Prevention, Fujian: collaborator
• Beijing Institute of Biological Products Co Ltd.: collaborator

Study Sites (5)

Nan'an Center for Disease Control and Prevention

Quanzhou, Fujian, China

Location

Yong'an Center for Disease Control and Prevention

Sanming, Fujian, China

Location

Youxi Center for Disease Control and Prevention

Sanming, Fujian, China

Location

Songtao Miao Autonomous County Center for Disease Control and Prevention

Tongren, Guizhou, China

Location

Linli County Center for Disease Control and Prevention

Changde, Hunan, China

Location

MeSH Terms

Interventions

COVID-19 Vaccines

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Central Study Contacts

FangJun LI

CONTACT

+86-13574109585; ymlc05@hncdc.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Serum testing technicians will be masked.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 30, 2021
• First Posted: November 3, 2021
• Study Start: November 1, 2021
• Primary Completion: November 1, 2022
• Study Completion: December 1, 2022
• Last Updated: November 3, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

CN (5)