- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05198102
ZF2001 Booster Immunization Clinical Trials of 12 Months After the Completion of Basic Immunization
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
Study Overview
Status
Conditions
Intervention / Treatment
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 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.
Study Type
Enrollment (Actual)
Phase
- Phase 2
- Phase 1
Contacts and Locations
Study Locations
-
-
Hunan
-
Changsha, Hunan, China, 410005
- Hunan Provincial Center for Disease Control And Prevention
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Investigational vaccine group
Recombinant novel coronavirus vaccine (CHO cells) injection, Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person
dose.
|
At 12 months after the basic immunization (window period ± 3 months), 1 dose of recombinant novel coronavirus vaccine (CHO cells) is vaccinated.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Immunogenicity endpoint
Time Frame: 14 days after booster vaccination
|
Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody
|
14 days after booster vaccination
|
Immunogenicity endpoint
Time Frame: 30 days after booster vaccination
|
Geometric mean titer (GMT) of SARS-CoV-2 neutralizing antibody and RBD protein binding antibody
|
30 days after booster vaccination
|
Immunogenicity endpoint
Time Frame: 6 months after booster vaccination
|
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
Time Frame: 14 days, 30 days, and 6 months after booster vaccination
|
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
Time Frame: Within 1 month after booster vaccination
|
Incidence of all AEs
|
Within 1 month after booster vaccination
|
Safety endpoint
Time Frame: Within 6 months after booster vaccination
|
Incidence of all SAEs
|
Within 6 months after booster vaccination
|
Collaborators and Investigators
Investigators
- Principal Investigator: Tao Huang, Bachelor, Hunan Provincial Center for Disease Control And Prevention
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Other Study ID Numbers
- LKM-2021-NCV-JQ02
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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