Status:
COMPLETED
ZF2001 Booster Immunization Clinical Trials of 12 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
- Participated in "A Phase III Randomized, Double-blind, Placebo-controlled Clinical Trial in 18 Years of Age and Above to Determine the Safety and Efficacy of ZF2001, a Recombinant Novel Coronavirus Vaccine (CHO cell) for Prevention of COVID-19. Protocol no.: LKM-2020-NCV-GJ01)" and has completed basic immunization with recombinant novel coronavirus vaccine (CHO cells) since 12 months (window period ± 3 months);
- 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 new coronavirus infection or asymptomatic infection or a history of positive new 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 transplant 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 new coronavirus vaccine (CHO cell) within the past 15 months, has participated in or is participating in other COVID-19 related clinical trials;
- Researchers believe that any disease or condition in the subject 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 :
December 29 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 19 2022
Estimated Enrollment :
300 Patients enrolled
Trial Details
Trial ID
NCT05198102
Start Date
December 29 2021
End Date
July 19 2022
Last Update
September 29 2022
Active Locations (1)
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1
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, China, 410005