A Trial Evaluate the Immunogenicity and Safety of Recombinant COVID-19 Omicron-Delta Variant Vaccine (CHO Cell)
Anhui Zhifei Longcom Biologic Pharmacy co. Ltd.
1 other identifier
interventional
400
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3 covid19
Started Nov 2022
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 7, 2022
CompletedFirst Submitted
Initial submission to the registry
November 11, 2022
CompletedFirst Posted
Study publicly available on registry
November 15, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 30, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 30, 2023
CompletedNovember 15, 2022
November 1, 2022
9 months
November 11, 2022
November 11, 2022
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
6 months
Secondary Outcomes (5)
Immunogenic end points 2
6 months
Immunogenic end points 3
6 months
Immunogenic end points 4
6 months
Immunogenic end points 5
6 months
Immunogenic end points 6
6 months
Study Arms (3)
Test group
EXPERIMENTALPeople more than 4 months after completing basic immunization with recombinant novel coronavirus protein vaccine (CHO cells)
control group
ACTIVE COMPARATORPeople more than 4 months after completing basic immunization with recombinant novel coronavirus protein vaccine (CHO cells)
Observation group
EXPERIMENTALPeople over 4 months after completing basic immunization with COVID-19 mRNA vaccine
Interventions
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.
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
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Uzbekistan, Tashkent city, Said baraka street 10
Tashkent, 100012, Uzbekistan
Related Publications (1)
Li D, Duan M, Wang X, Gao P, Zhao X, Xu K, Gao GF. Neutralization of BQ.1, BQ.1.1, and XBB with RBD-Dimer Vaccines. N Engl J Med. 2023 Mar 23;388(12):1142-1145. doi: 10.1056/NEJMc2216233. Epub 2023 Mar 1. No abstract available.
PMID: 36856580DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Erkin Musabaev, Dr.
Research institute of virology
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 11, 2022
First Posted
November 15, 2022
Study Start
November 7, 2022
Primary Completion
July 30, 2023
Study Completion
September 30, 2023
Last Updated
November 15, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share