Evaluation of Immunogenicity, Safety and Antibody Persistence of COVID-19 Booster Vaccine (Produced in Beijing) in Patients With Hypertension and/or Diabetes
NCT ID: NCT05104333
Last Updated: 2021-11-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE4
1440 participants
INTERVENTIONAL
2021-11-30
2022-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
These subjects are all from the "COVAX (HT/DM)-Beijing" clinical trial (NCT05065879). 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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
PARALLEL
PREVENTION
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
0-1-4 schedule group
Subjects receive the booster vaccine 3 months after the second dose.
Covid-19 vaccine (0-1-4 schedule)
Subjects receive the booster vaccine 3 months after the second dose.
0-1-6 schedule group
Subjects receive the booster vaccine 5 months after the second dose.
Covid-19 vaccine (0-1-6 schedule)
Subjects receive the booster vaccine 5 months after the second dose.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Covid-19 vaccine (0-1-4 schedule)
Subjects receive the booster vaccine 3 months after the second dose.
Covid-19 vaccine (0-1-6 schedule)
Subjects receive the booster vaccine 5 months after the second dose.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
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.
Exclusion Criteria
* 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.
60 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Guizhou Center for Disease Control and Prevention
OTHER
Hunan Provincial Center for Disease Control and Prevention
OTHER
Center for Disease Control and Prevention, Fujian
OTHER
Beijing Institute of Biological Products Co Ltd.
INDUSTRY
China National Biotec Group Company Limited
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Nan'an Center for Disease Control and Prevention
Quanzhou, Fujian, China
Yong'an Center for Disease Control and Prevention
Sanming, Fujian, China
Youxi Center for Disease Control and Prevention
Sanming, Fujian, China
Songtao Miao Autonomous County Center for Disease Control and Prevention
Tongren, Guizhou, China
Linli County Center for Disease Control and Prevention
Changde, Hunan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
COVAX BOOSTER (HT/DM)-Beijing
Identifier Type: -
Identifier Source: org_study_id