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A Trial Evaluate the Immunogenicity and Safety of Recombinant COVID-19 Omicron-Delta Variant Vaccine (CHO Cell)

Primary Purpose

COVID-19

Status
Recruiting
Phase
Phase 3
Locations
Uzbekistan
Study Type
Interventional
Intervention
Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells)
Recombinant Novel Coronavirus Protein 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 IgG, GMC

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: Age eligible for observation in this clinical trial: adults aged 18 years and above Subjects voluntarily participate in this study, sign informed consent, provide legal identification, and understand and comply with the requirements of the test protocol More than 4 months after the completion of the whole course of recombinant novel coronavirus protein vaccine (CHO cell) basic immunization or more than 4 months after the completion of the novel coronavirus mRNA vaccine basic immunization Female and male participants of childbearing age took effective contraception during the study period Exclusion Criteria: Prior history of severe allergy to any vaccine or to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angineurotic edema, etc.; Suspected or confirmed fever (axillary temperature ≥37.3℃/ mouth temperature ≥37.5℃) within 72 hours before enrollment, or armpit temperature ≥37.3℃/ mouth temperature ≥37.5℃ on the day of enrollment; Confirmed cases of COVID-19 infection, asymptomatic infected persons or positive nucleic acid test history of COVID-19; Uncontrolled lymphoproliferative disease, unremission stage of aplastic anemia, active stage of primary immune thrombocytopenia (ITP), uncontrolled stage of coagulation disease, etc. a history of congenital or acquired immunodeficiency or autoimmune disease; Absence of spleen, or history of splenic surgery, trauma, or immunomodulator treatment within 6 months, such as immunosuppressive dose of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week); Or monoclonal antibodies; Or thymosin; Or interferon; But topical use (such as ointments, eye drops, inhalants or nasal sprays) is permitted; Subunit vaccine and inactivated vaccine should be administered within 14 days before vaccination, and live attenuated vaccine should be administered within 30 days before vaccination; Patients with malignant tumors who are undergoing chemotherapy, radiotherapy or immunotherapy before and after surgery; Patients with organ transplant status; People with uncontrolled epilepsy and other progressive neurological diseases (e.g. Transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.); Patients with acute disease, or acute episodes of chronic disease, or uncontrolled severe chronic disease, such as medically uncontrolled hypertension (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg); lactating or pregnant women; The investigator believes that the subject has any disease or condition that could put the subject at risk; The subject is unable to complete the trial as required by the protocol, and there are circumstances that interfere with the assessment of vaccine response.

Sites / Locations

  • Uzbekistan, Tashkent city, Said baraka street 10Recruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Experimental

Arm Label

Test group

control group

Observation group

Arm Description

People more than 4 months after completing basic immunization with recombinant novel coronavirus protein vaccine (CHO cells)

People more than 4 months after completing basic immunization with recombinant novel coronavirus protein vaccine (CHO cells)

People over 4 months after completing basic immunization with COVID-19 mRNA vaccine

Outcomes

Primary Outcome Measures

Immunogenic end points
Geometric mean concentration (GMC) of RBD protein-binding Antibody (IgG) against Omicron variant of novel coronavirus at 14 days after vaccination in experimental group and control group.

Secondary Outcome Measures

Immunogenic end points 2
RBD protein-bound antibody (IgG) growth ratio (GMI) and positive turnover rate for Omicron variant of novel coronavirus at 14 days after vaccination in experimental group and control group;
Immunogenic end points 3
RBD protein-binding antibody (IgG) GMC, GMI and positive turnover were detected against the primary COVID-19 strain and Delta variant 14 days after vaccination in experimental group.
Immunogenic end points 4
RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants 6 months after vaccination in the experimental group
Immunogenic end points 5
RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants were detected 14 days after vaccination in the observation group
Immunogenic end points 6
RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants in the observation group for 6 months

Full Information

First Posted
November 11, 2022
Last Updated
November 11, 2022
Sponsor
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT05616754
Brief Title
A Trial Evaluate the Immunogenicity and Safety of Recombinant COVID-19 Omicron-Delta Variant Vaccine (CHO Cell)
Official Title
Anhui Zhifei Longcom Biologic Pharmacy co. Ltd.
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 7, 2022 (Actual)
Primary Completion Date
July 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)

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

5. Study Description

Brief Summary
The study was designed as a randomized, blind and controlled trial. A total of 300 patients aged 18 and above who were immunized with recombinant novel coronavirus protein vaccine (CHO cell) for more than 4 months (60 patients aged 60 and above) were randomly and blind divided into the experimental group and the control group, and received the experimental vaccine and the control vaccine, respectively. In addition, 100 patients over 4 months after the completion of basic immunization with COVID-19 mRNA vaccine were selected as the open observation group, all of whom received 1 dose of experimental vaccine.
Detailed Description
The improved vaccine was developed against the Delta and Omicron COVID-19 variants. The overall design of this clinical trial was as follows: A total of 300 patients aged 18 and above who completed the basic immunization of recombinant novel coronavirus protein vaccine (CHO cell) for more than 4 months were randomly divided into the experimental group and the control group in a blind way, and were inoculated with the experimental vaccine and the control vaccine respectively. In addition, 100 patients over 4 months after the completion of basic immunization with COVID-19 mRNA vaccine were selected as the open observation group, all of whom received 1 dose of experimental vaccine. The main objective was to evaluate the immunogenicity and safety of Omicron-Delta recombinant novel coronavirus protein vaccine (CHO cells) against Omicron variants of novel coronavirus in people aged 18 years and above.

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
400 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Test group
Arm Type
Experimental
Arm Description
People more than 4 months after completing basic immunization with recombinant novel coronavirus protein vaccine (CHO cells)
Arm Title
control group
Arm Type
Active Comparator
Arm Description
People more than 4 months after completing basic immunization with recombinant novel coronavirus protein vaccine (CHO cells)
Arm Title
Observation group
Arm Type
Experimental
Arm Description
People over 4 months after completing basic immunization with COVID-19 mRNA vaccine
Intervention Type
Biological
Intervention Name(s)
Omicron-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO cells)
Intervention Description
The antigen protein of this product is designed to be expressed in tandem with Delta variant R319-N356 and Omicron variant R319-N356. The antigen is called DO-RBD for short.
Intervention Type
Biological
Intervention Name(s)
Recombinant Novel Coronavirus Protein Vaccine (CHO cells)
Intervention Description
This strain was made from the NCP-RBD receptor binding region of the spike glycoprotein of novel coronavirus expressed in recombinant CHO cells, which was purified and added with aluminum hydroxide adjuvant
Primary Outcome Measure Information:
Title
Immunogenic end points
Description
Geometric mean concentration (GMC) of RBD protein-binding Antibody (IgG) against Omicron variant of novel coronavirus at 14 days after vaccination in experimental group and control group.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Immunogenic end points 2
Description
RBD protein-bound antibody (IgG) growth ratio (GMI) and positive turnover rate for Omicron variant of novel coronavirus at 14 days after vaccination in experimental group and control group;
Time Frame
6 months
Title
Immunogenic end points 3
Description
RBD protein-binding antibody (IgG) GMC, GMI and positive turnover were detected against the primary COVID-19 strain and Delta variant 14 days after vaccination in experimental group.
Time Frame
6 months
Title
Immunogenic end points 4
Description
RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants 6 months after vaccination in the experimental group
Time Frame
6 months
Title
Immunogenic end points 5
Description
RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants were detected 14 days after vaccination in the observation group
Time Frame
6 months
Title
Immunogenic end points 6
Description
RBD protein-binding antibody (IgG) GMC, GMI and positive turnover against the primary COVID-19 strain, Delta and Omicron variants in the observation group for 6 months
Time Frame
6 months

10. Eligibility

Sex
All
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Age eligible for observation in this clinical trial: adults aged 18 years and above Subjects voluntarily participate in this study, sign informed consent, provide legal identification, and understand and comply with the requirements of the test protocol More than 4 months after the completion of the whole course of recombinant novel coronavirus protein vaccine (CHO cell) basic immunization or more than 4 months after the completion of the novel coronavirus mRNA vaccine basic immunization Female and male participants of childbearing age took effective contraception during the study period Exclusion Criteria: Prior history of severe allergy to any vaccine or to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angineurotic edema, etc.; Suspected or confirmed fever (axillary temperature ≥37.3℃/ mouth temperature ≥37.5℃) within 72 hours before enrollment, or armpit temperature ≥37.3℃/ mouth temperature ≥37.5℃ on the day of enrollment; Confirmed cases of COVID-19 infection, asymptomatic infected persons or positive nucleic acid test history of COVID-19; Uncontrolled lymphoproliferative disease, unremission stage of aplastic anemia, active stage of primary immune thrombocytopenia (ITP), uncontrolled stage of coagulation disease, etc. a history of congenital or acquired immunodeficiency or autoimmune disease; Absence of spleen, or history of splenic surgery, trauma, or immunomodulator treatment within 6 months, such as immunosuppressive dose of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week); Or monoclonal antibodies; Or thymosin; Or interferon; But topical use (such as ointments, eye drops, inhalants or nasal sprays) is permitted; Subunit vaccine and inactivated vaccine should be administered within 14 days before vaccination, and live attenuated vaccine should be administered within 30 days before vaccination; Patients with malignant tumors who are undergoing chemotherapy, radiotherapy or immunotherapy before and after surgery; Patients with organ transplant status; People with uncontrolled epilepsy and other progressive neurological diseases (e.g. Transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.); Patients with acute disease, or acute episodes of chronic disease, or uncontrolled severe chronic disease, such as medically uncontrolled hypertension (systolic blood pressure ≥150mmHg and/or diastolic blood pressure ≥100mmHg); lactating or pregnant women; The investigator believes that the subject has any disease or condition that could put the subject at risk; The subject is unable to complete the trial as required by the protocol, and there are circumstances that interfere with the assessment of vaccine response.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Akhmedova Guzal, Bachelor
Phone
998-935281313
Email
abidovagoga@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erkin Musabaev, Dr.
Organizational Affiliation
Research institute of virology
Official's Role
Principal Investigator
Facility Information:
Facility Name
Uzbekistan, Tashkent city, Said baraka street 10
City
Tashkent
ZIP/Postal Code
100012
Country
Uzbekistan
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Akhmedova Guzal, Bachelor
Phone
998-935281313

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

A Trial Evaluate the Immunogenicity and Safety of Recombinant COVID-19 Omicron-Delta Variant Vaccine (CHO Cell)

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