ZF2001 Booster Immunization Clinical Trials of 12 Months After the Completion of Basic Immunization

Study Overview
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Brief Summary
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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 18 years old and above who have completed the basic immunization of recombinant novel coronavirus vaccine (CHO cells), to evaluate the immunogenicity and safety of the booster immunization of 12 months (window period ± 3 months) after the basic immunization. Investigate the geometric mean titer (GMT), GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody 14 days, 30 days, and 6 months after booster vaccination; the incidence of all AEs within 1 month after the booster vaccination, the incidence of all serious adverse events (SAE) within 6 months after the booster vaccination.

Detailed Description
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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 cells), to evaluate the immunogenicity and safety of the booster immunization of 12 months (window period ± 3 months) after the basic immunization. Immunogenicity observation: the geometric mean titer (GMT), GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody 14 days, 30 days, and 6 months after booster vaccination. Safety observation: All adverse events (AE) were collected within 30 minutes after the booster immunization, all AEs (including both solicited and unsolicited AEs) 0-7 days after the booster immunization, and all AEs (unsolicited AEs) 8-30 days after the booster immunization. Solicited AE (the following events occurring within 7 days of vaccination) : Adverse events at the inoculation site (local) : pain, pruritus, redness, swelling, rash, induration; Non-inoculated site (systemic) adverse events: fever, headache, fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute allergic reactions, cough. All SAEs were collected within 6 months after the booster immunization.

Official Title
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To Evaluate the Immunogenicity and Safety of Booster Immunization 12 Months After the Completion of Basic Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cell) in People 18 Years Old and Above

Conditions
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Prevention of COVID-19

Intervention / Treatment
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* Biological: Recombinant novel coronavirus vaccine (CHO cells)


Participation Criteria
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Eligibility Criteria
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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: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Investigational vaccine group<br>Recombinant novel coronavirus vaccine (CHO cells) injection, Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose. | Biological: Recombinant novel coronavirus vaccine (CHO cells)<br>* At 12 months after the basic immunization (window period ± 3 months), 1 dose of recombinant novel coronavirus vaccine (CHO cells) is vaccinated.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity endpoint | Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody | 14 days after booster vaccination | 
| Immunogenicity endpoint | Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody | 30 days after booster vaccination | 
| Immunogenicity endpoint | Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody | 6 months after booster vaccination | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Immunogenicity endpoint | GMI and 4 times growth rate of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody | 14 days, 30 days, and 6 months after booster vaccination | 
| Safety endpoint | Incidence of all AEs | Within 1 month after booster vaccination | 
| Safety endpoint | Incidence of all SAEs | Within 6 months after booster vaccination |