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To Evaluate the Immunogenicity and Safety of Sequential Booster Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cells) for SARS-CoV-2

Primary Purpose

COVID-19

Status
Completed
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Recombinant Novel Coronavirus vaccine (CHO Cells)
Sponsored by
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for COVID-19 focused on measuring COVID-19 vaccine

Eligibility Criteria

3 Years - 17 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Healthy subjects aged 3 to 17 years who can provide vaccination information proving that they have received two doses of commercially available Novel Coronavirus inactivated vaccine in the last 6-9 months; The subject voluntarily agrees to participate in the study (and/or the subject's legal guardian voluntarily agrees to allow the child to participate in the study), and the guardian and the subject (aged 8-17) sign the informed consent, and can provide valid identification; Understand and comply with test protocol requirements; Armpit temperature < 37.3℃ (> 14 years old), armpit temperature < 37.5℃ (≤14 years old); Female subjects of reproductive age agree to use effective contraceptive measures from the beginning to the end of the study. Exclusion Criteria: History of confirmed or asymptomatic coronavirus infection or positive nucleic acid test of novel Coronavirus infection; SARS virus disease history or SARS-COV-2 history; Have taken antipyretics or painkillers within 24 hours before vaccination; Have a history of severe allergy to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angiopantic edema, etc.; Persons suffering from the following diseases: In the past 7 days, have suffered from digestive diseases (such as diarrhea, abdominal pain, vomiting, etc.); congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; have thrombocytopenia, any coagulation dysfunction or receive anticoagulant treatment, etc.; Neurological disorders or neurodysplasia (e.g., migraines, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficits, Guillain-Barre syndrome, encephalomyelitis or transverse myelitis); History of mental illness or family history; History of congenital or acquired immune deficiency or autoimmune disease or treatment with immunomodulators within 6 months, such as immunosuppressive doses of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week); Or monoclonal antibodies; Or thymosin; Or interferon; However, topical use (such as ointments, eye drops, inhalants or nasal sprays) is allowed; Known to have been diagnosed with an infectious disease, such as active tuberculosis, viral hepatitis or treponema pallidum; Subunit vaccine and inactivated vaccine should be administered within 14 days before experimental vaccine, and live attenuated vaccine should be administered within 30 days before experimental vaccine; Have received blood or blood-related products, including immunoglobulin, within 3 months prior to the trial vaccine; Or planned for use during the study period; People aged 3-17 years who have participated in or are participating in other COVID-19 related clinical trials or have received other COVID-19 vaccines, except those who have completed two doses of marketed Novel Coronavirus inactivated vaccine within 6-9 months; Pregnant (including positive urine pregnancy), or breast-feeding; The Investigator believes that the subject has any disease or condition that may place the subject at unacceptable risk; Subjects cannot meet the requirements of the program; Conditions that interfere with the assessment of vaccine response.

Sites / Locations

  • Hunan Provincial Center for Disease Control and Prevention

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Experimental group

Arm Description

1 dose of the test recombinant novel coronavirus vaccine (CHO cell) was injected into the deltoid muscle of the subject's upper arm

Outcomes

Primary Outcome Measures

SARS-COV-2 neutralizing antibody
Titers of SARS-COV-2 neutralizing Antibody at 14 days and 6 months after vaccination of recombinant Novel Coronavirus vaccine (CHO cells) (GMT)

Secondary Outcome Measures

SARS-COV-2 neutralizing antibody
GMI and 4-fold increase in SARS-COV-2 neutralizing antibody at 14 days and 6 months after intensification of recombinant Novel Coronavirus vaccine (CHO cells)

Full Information

First Posted
May 22, 2023
Last Updated
June 6, 2023
Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05895110
Brief Title
To Evaluate the Immunogenicity and Safety of Sequential Booster Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cells) for SARS-CoV-2
Official Title
To Evaluate the Immunogenicity and Safety of Sequentially Enhanced Recombinant Novel Coronavirus Vaccine (CHO Cells) in Patients Aged 3-17 Years After Completion of Two Doses of Novel Coronavirus Inactivated Vaccine
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Completed
Study Start Date
April 29, 2022 (Actual)
Primary Completion Date
November 19, 2022 (Actual)
Study Completion Date
November 19, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
An open experimental design was used in this study, and 240 subjects were planned to be enrolled. To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential intensification in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.
Detailed Description
One dose of recombinant novel coronavirus vaccine (CHO cell) for test was injected into the upper arm deltoid muscle muscle of the subject

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
COVID-19
Keywords
COVID-19 vaccine

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
240 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Experimental group
Arm Type
Experimental
Arm Description
1 dose of the test recombinant novel coronavirus vaccine (CHO cell) was injected into the deltoid muscle of the subject's upper arm
Intervention Type
Biological
Intervention Name(s)
Recombinant Novel Coronavirus vaccine (CHO Cells)
Intervention Description
The experimental vaccine dose used in this study is 25μg/0.5mL. All subjects recruited should have received two doses of novel Coronavirus inactivated vaccine on the market for 6-9 months, and all eligible subjects will receive one dose of recombinant Novel Coronavirus vaccine (CHO cells).
Primary Outcome Measure Information:
Title
SARS-COV-2 neutralizing antibody
Description
Titers of SARS-COV-2 neutralizing Antibody at 14 days and 6 months after vaccination of recombinant Novel Coronavirus vaccine (CHO cells) (GMT)
Time Frame
14 days and 6 months after inoculation
Secondary Outcome Measure Information:
Title
SARS-COV-2 neutralizing antibody
Description
GMI and 4-fold increase in SARS-COV-2 neutralizing antibody at 14 days and 6 months after intensification of recombinant Novel Coronavirus vaccine (CHO cells)
Time Frame
14 days and 6 months after inoculation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
3 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Healthy subjects aged 3 to 17 years who can provide vaccination information proving that they have received two doses of commercially available Novel Coronavirus inactivated vaccine in the last 6-9 months; The subject voluntarily agrees to participate in the study (and/or the subject's legal guardian voluntarily agrees to allow the child to participate in the study), and the guardian and the subject (aged 8-17) sign the informed consent, and can provide valid identification; Understand and comply with test protocol requirements; Armpit temperature < 37.3℃ (> 14 years old), armpit temperature < 37.5℃ (≤14 years old); Female subjects of reproductive age agree to use effective contraceptive measures from the beginning to the end of the study. Exclusion Criteria: History of confirmed or asymptomatic coronavirus infection or positive nucleic acid test of novel Coronavirus infection; SARS virus disease history or SARS-COV-2 history; Have taken antipyretics or painkillers within 24 hours before vaccination; Have a history of severe allergy to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angiopantic edema, etc.; Persons suffering from the following diseases: In the past 7 days, have suffered from digestive diseases (such as diarrhea, abdominal pain, vomiting, etc.); congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; have thrombocytopenia, any coagulation dysfunction or receive anticoagulant treatment, etc.; Neurological disorders or neurodysplasia (e.g., migraines, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficits, Guillain-Barre syndrome, encephalomyelitis or transverse myelitis); History of mental illness or family history; History of congenital or acquired immune deficiency or autoimmune disease or treatment with immunomodulators within 6 months, such as immunosuppressive doses of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week); Or monoclonal antibodies; Or thymosin; Or interferon; However, topical use (such as ointments, eye drops, inhalants or nasal sprays) is allowed; Known to have been diagnosed with an infectious disease, such as active tuberculosis, viral hepatitis or treponema pallidum; Subunit vaccine and inactivated vaccine should be administered within 14 days before experimental vaccine, and live attenuated vaccine should be administered within 30 days before experimental vaccine; Have received blood or blood-related products, including immunoglobulin, within 3 months prior to the trial vaccine; Or planned for use during the study period; People aged 3-17 years who have participated in or are participating in other COVID-19 related clinical trials or have received other COVID-19 vaccines, except those who have completed two doses of marketed Novel Coronavirus inactivated vaccine within 6-9 months; Pregnant (including positive urine pregnancy), or breast-feeding; The Investigator believes that the subject has any disease or condition that may place the subject at unacceptable risk; Subjects cannot meet the requirements of the program; Conditions that interfere with the assessment of vaccine response.
Facility Information:
Facility Name
Hunan Provincial Center for Disease Control and Prevention
City
Changsha
State/Province
Hunan
ZIP/Postal Code
410005
Country
China

12. IPD Sharing Statement

Learn more about this trial

To Evaluate the Immunogenicity and Safety of Sequential Booster Immunization of Recombinant Novel Coronavirus Vaccine (CHO Cells) for SARS-CoV-2

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