Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells)

Study Overview
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Brief Summary
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Popular title: Clinical study of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells). Purpose of the study: Main objectives: To evaluate the immunogenicity and safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (XBB, BA.5, BF.7) after receiving 2 doses according to different immunization schedules in people aged 18 years and older. Secondary purposes: To evaluate the immune persistence of Omicron BA.4/5-Delta recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (XBB, BA.5, BF.7) after receiving 2 doses according to different immunization schedules in people aged 18 years and older. Overall design: Studies were randomized, double-blind, active-controlled study design. Study group: There were 160 participants aged 18 years and older, including 80 people aged 60 years and older. Study group：Among them, 80 subjects were from the randomized, double-blind, active-controlled clinical study to evaluate the immunogenicity and safety of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) in people aged 18 years and older, protocol number: LKM-2023-NCV-02, 40 cases in the study group and 40 cases in the control group, and completed the second dose of vaccine at the 6th month visit to observe immunogenicity and safety. The remaining 80 subjects were randomly blinded to the 1:1 ratio into the research group and the control group and received 2 doses of the experimental vaccine according to the 0-1-month procedure to observe immunogenicity and safety.

Official Title
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A Randomized, Double-blind, Active-controlled Clinical Study Evaluating the Immunogenicity and Safety of Omicron BA.4/5-Delta Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) in People Aged 18 Years and Older With Different Immunization Programs

Conditions
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Coronavirus

Intervention / Treatment
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* Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)
* Biological: Recombinant novel coronavirus protein vaccine (CHO cells)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Be 18 years of age or older at the time of signing the informed consent form. The subject himself voluntarily participates in the study, signs the informed consent form, and can provide legal identification, understand and comply with the requirements of the research protocol. More than 6 months after completing the basic immunization or booster immunization of the new coronavirus vaccine. Female subjects of childbearing age and male subjects who were able to use effective contraception during the study. Exclusion Criteria: Participants were not eligible for study if they had any of the following: Previous history of severe allergy to any vaccine, or history of severe allergy to any component of the study vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, dyspnea, angioedema, allergic constitution (such as allergy to two or more drugs, food or pollen), etc. fever (axillary body temperature≥ 37.3°C) within 72 hours before enrollment, or axillary body temperature ≥ 37.3°C on the day of enrollment. Patients infected with the new coronavirus within 3 months before enrollment (asymptomatic infection or positive nucleic acid or antigen test of the new coronavirus). Patients with aplastic anemia that has not been relieved, primary immune thrombocytopenia (ITP) active period, and uncontrolled coagulation diseases. history of congenital or acquired immunodeficiency or autoimmune disease; no history of spleen or spleen surgery or trauma; or receive immunomodulators within 6 months, such as corticosteroids in immunosuppressant doses (dose reference: equivalent to prednisone 20 mg/day for more than one week); or monoclonal antibodies; or thymus peptide; or interferon, etc.; However, topical medications (such as ointments, eye drops, inhalers, or nasal sprays) are allowed; Lymphoproliferative disorders are not controlled. Non-live vaccine ≤ 14 days before vaccination and live attenuated vaccine 30 days before ≤vaccination. Patients with malignant tumors who are undergoing chemotherapy, radiotherapy, immunotherapy, etc. before and after surgery, Patients in the state of organ transplantation. Those suffering from uncontrolled epilepsy and other progressive neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.). Patients with acute diseases, or acute exacerbations of chronic diseases, or uncontrolled severe chronic diseases, such as hypertension that cannot be controlled by drugs (systolic blood pressure ≥ 160mmHg and/or diastolic blood pressure ≥100mmHg). Lactating women or pregnant women; The investigator believes that the participant has any disease or condition that would put the participant at risk, the participant cannot complete the study as required by the protocol, and there are circumstances that interfere with the assessment of 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 0-1-month immune program study group<br>According to the 0-1-month immunization schedule, two doses of 25 μg/0.5 ml Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) were injected into the deltoid muscle of the upper arm. | Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)<br>* Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells).<br>|
| Active Comparator: 0-1-month immune program control group<br>According to the 0-1-month immunization schedule, two doses of 25 μg/0.5 ml recombinant novel coronavirus protein vaccine (CHO cells) were injected into the deltoid muscle of the upper arm. | Biological: Recombinant novel coronavirus protein vaccine (CHO cells)<br>* Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Recombinant new coronavirus vaccine (CHO cells).<br>|
| Experimental: 0-6-month immune program study group<br>The subjects were from the LKM-2023-NCV-02 project and were vaccinated on a voluntary basis with 25 μg/0.5 ml Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) at the visit 6 months after the exemption. | Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)<br>* Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells).<br>|
| Active Comparator: 0-6-month immune program control group<br>The subjects were from the LKM-2023-NCV-02 project and were vaccinated on a voluntary basis with 25 μg/0.5 ml recombinant novel coronavirus protein vaccine (CHO cells) at the visit 6 months after the exemption. | Biological: Recombinant novel coronavirus protein vaccine (CHO cells)<br>* Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Recombinant new coronavirus vaccine (CHO cells).<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of adverse events after 2 doses given intramuscularly according to different immunization programs | The observation of adverse events mainly come from vital sign detection and laboratory examination (including blood routine/urine routine/blood biochemistry/electrocardiogram and chest X-ray), local reactions and systemic reactions after injection. | 6 months after 2 doses of vaccine | 
| Laboratory markers of immunity after 2 doses given intramuscularly according to different immunization programs | Geometric mean titer (GMT) of neutralizing antibodies against the Omicron variant (XBB) after vaccination with the investigational vaccine. | 14 days after 2 doses of vaccine | 
| Immunogenic end points | Positive conversion rate of the Omicron variant (XBB) of the new coronavirus after vaccination with the investigational vaccine. | 14 days after 2 doses of vaccine | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Laboratory markers of immunity | Geometric mean titer (GMT) of neutralizing antibodies against the prototype novel coronavirus strain, Omicron strain (BA.4/5, BF.7) after 2 doses of vaccine candidate. | 14 days after 2 doses of vaccine | 
| Laboratory markers of immunity | Growth multiples (GMI) of the prototype new coronavirus strain and the Omicron variant (BA.4/5, BF.7) after 2 doses of investigational vaccine. | 14 days after 2 doses of vaccine | 
| Immunogenic end points | Positive conversion rate against the prototype Omicron variant (BA.4/5, BF.7) after 2 doses of study vaccine. | 14 days after 2 doses of vaccine | 
| Laboratory markers of immunity | Growth multiple (GMI) of the new coronavirus Omicron variant (XBB) after 2 doses of investigational vaccine. | 14 days after 2 doses of vaccine | 
| Laboratory markers of immunity | Geometric mean titer (GMT) of neutralizing antibodies against the prototype novel coronavirus strain, Omicron strain (XBB, BA.4/5, BF.7) after 2 doses of vaccine candidate. | 6 months after 2 doses of vaccine | 
| Laboratory markers of immunity | Growth multiples (GMI) of the prototype new coronavirus strain and the Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of investigational vaccine. | 6 months after 2 doses of vaccine | 
| Immunogenic end points | Positive conversion rate against the prototype Omicron variant (XBB, BA.4/5, BF.7) after 2 doses of study vaccine. | 6 months after 2 doses of vaccine | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Omicron BA.4/5-Delta strain