Status:
COMPLETED
ZF2001 Booster Immunization Clinical Trials of 6 Months After the Completion of Basic Immunization
Lead Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Conditions:
Prevention of COVID-19
Eligibility:
All Genders
18+ years
Phase:
PHASE1
PHASE2
Brief Summary
The purpose of this study is to evaluate the immunogenicity and safety of the recombinant novel coronavirus vaccine (CHO cells) after the booster immunization. It is planned to screen 300 subjects of ...
Detailed Description
This study adopts an open experimental design. It is planned to screen 300 subjects of 18 years old and above who have completed the basic immunization of recombinant novel coronavirus vaccine (CHO ce...
Eligibility Criteria
Inclusion
- Subjects of 18 years old and above who has completed basic immunization with recombinant novel coronavirus vaccine (CHO cells) since 6 months (window period ± 1 month);
- The subjects voluntarily participate in the study, sign an informed consent form, and can provide valid identification, understand and comply with the requirements of the trial protocol;
- Female subjects of childbearing age agree to take effective contraceptive measures from the start of the study to 1 month after vaccination.
Exclusion
- A confirmed case of novel coronavirus infection or asymptomatic infection or a history of positive novel coronavirus nucleic acid test;
- Patients with uncontrolled lymphoproliferative diseases, unresolved aplastic anemia, active primary immune thrombocytopenia (ITP), uncontrolled coagulopathy, etc;
- Patients with malignant tumors before and after surgery, patients undergoing chemotherapy, radiotherapy, immunotherapy, etc.; patients with organ transplantation status;
- People with uncontrolled epilepsy and other serious neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.);
- Suffering from acute diseases, or acute attacks of chronic diseases, or uncontrolled severe chronic diseases, such as hypertension that cannot be controlled by drugs (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg);
- Previous history of severe allergies to any vaccine, or history of severe allergies to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, vascular nerve Sexual edema, etc;
- Women who are breastfeeding or pregnant;
- In addition to completing the recombinant novel coronavirus vaccine (CHO cell) within the past 7 months, has participated or is participating in other COVID-19 related clinical trials;
- Investigators believe that any disease or condition may put the subject at an unacceptable risk; the subject cannot meet the requirements of the protocol; the situation that interferes with the assessment of the vaccine response.
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 6 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05198063
Start Date
January 10 2022
End Date
December 6 2022
Last Update
June 15 2023
Active Locations (1)
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1
Hunan Provincial Center for Disease Control and Prevention Preventive Medicine Clinic
Changsha, Hunan, China, 410005