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| Column | Value |
|---|---|
| Trial registration number | NCT05198102 |
|
Full text link
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
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First author
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
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Contact
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
Not reported |
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Registration date
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
2022-01-20 |
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Recruitment status
Last imported at : Sept. 30, 2022, 6:30 a.m. Source : ClinicalTrials.gov |
Completed |
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Study design
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
nonRCT |
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Allocation
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
Non-randomized |
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Design
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
Single group assignment |
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Masking
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
Open label |
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Center
Last imported at : March 15, 2023, 4 a.m. Source : ClinicalTrials.gov |
single-center |
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Study aim
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
Prevention |
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Inclusion criteria
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
inclusion criteria: 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 criteria
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
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. |
|
Number of arms
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
1 |
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Funding
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. |
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Inclusion age min
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
18 |
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Inclusion age max
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
100 |
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Countries
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
China |
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Type of patients
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
Healthy volunteers |
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Severity scale
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
N/A |
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Total sample size
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
300 |
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primary outcome
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
Immunogenicity endpoint;Immunogenicity endpoint;Immunogenicity endpoint |
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Notes
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
None |
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Phase
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
Phase 1/Phase 2 |
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Arms
Last imported at : Jan. 21, 2022, noon Source : ClinicalTrials.gov |
[{"arm_notes": "25\u03bcg/0.5ml/person dose;1;IM; 12 months after the basic immunization (window period \u00b1 3 months)", "treatment_id": 1088, "treatment_name": "Recombinant sars-cov-2 vaccine (cho cell)", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}] |