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

May 9, 2024 updated by: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

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

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 (BA.5, BF.7) after vaccination in people aged 18 years and older. Secondary purposes: To evaluate the immune persistence of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (BA.5, BF.7) after vaccination in people aged 18 years and older.

Overall design: Studies were randomized, double-blind, active, controlled study design.

Study group: people aged 18 years and above who have completed primary immunization or booster immunization of the new coronavirus vaccine for more than 6 months.

Study group: Randomly divided into study group and control group according to the 1:1 ratio, of which 225 subjects in the study group and 225 subjects in the control group were vaccinated with study vaccine and control vaccine respectively.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Popular title: Clinical study of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells). Research vaccine: Name: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cell), main components: receptor binding region (OD-RBD) protein (25μg/0.5mL) of novel coronavirus spike glycoprotein, aluminum hydroxide adjuvant. Control vaccine: Name: Recombinant novel coronavirus protein vaccine (CHO cells), main components: receptor-binding region (NCP-RBD) protein (25μg/0.5mL) of novel coronavirus spike glycoprotein, aluminum hydroxide adjuvant. Indications: Prevention of respiratory diseases caused by novel coronavirus infection Research population: healthy people ≥60 years old Research institution: Yijishan Hospital, Wannan Medical College Research Objective: Main objective: To evaluate the immunogenicity and safety of Omicron BA.4/5-Delta recombinant novel coronavirus protein vaccine (CHO cells) against the prototype strain of the new coronavirus and Omicron variant (BA.5, BF.7) after vaccination in people aged 18 years and above.

Secondary objective: To evaluate the immune persistence of Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) against the new coronavirus prototype strain and Omicron variant (BA.5, BF.7) after vaccination in people aged 18 years and above.

Research Plan: Sample size: Based on the efficacy test of the experimental group against the new coronavirus Omicron strain BA.4/5 and the control group against the new coronavirus Omicron strain BA.4/5 free neutralizing antibody GMC, the standard deviation of the antibody level after logarithmic conversion with base 10 is assumed to be σ = 0.65. With an overall power of 90%, a class I error of 0.025 on one side, a 95% confidence interval lower bound of the GMC ratio >1, and an expected GMC ratio of 2.1, 81 cases are required for each group. In summary, considering about 15% shedding, the sample size of the experimental group and the control group was allocated 1:1, that is, 100 cases were needed in each group, and a total of 200 cases were needed. At the same time, according to the guiding principles, in order to observe the safety of the test seedlings, the total sample size was expanded to 450 cases, that is, 225 cases were required for the experimental group and the control group.

Study group: The study plans to recruit 450 cases of people aged 18 and above who have completed the basic immunization or booster immunization of the new coronavirus vaccine for more than 6 months, and are randomly divided into the research group and the control group according to the ratio of 1:1, of which 225 subjects in the research group and 225 subjects in the control group are vaccinated with the study vaccine and the control vaccine respectively. The 450 participants should include 150 elderly (60 years and older) and 300 adults (18-59 years old).This clinical trial will set up immunogenic subgroups in the enrolled 450 patients, a total of 200 cases, including 100 cases in the study group and 100 cases in the control group. All subjects were tested for neutralizing antibody immunogenicity (BA.5 strain) in pre-neutralizing serum, and the first 100 subjects in the study group and control group were included in the immunogenicity subgroup in order of study number. If there are less than 100 neutralizing antibody negative subjects in the study group or control group, the immunogenic subgroup of neutralizing antibody positive subjects will be included in the immunogenic subgroup of neutralizing antibody positive subjects in the order of study number until the number reaches 100.

Safety endpoints:

1. Incidence of all AEs within 30 days of vaccination:

  1. incidence of total AE ;
  2. the incidence of AEs associated with the study vaccine ;
  3. Grade 3 and above AE incidence ;
  4. incidence of grade 3 and above AEs associated with the investigational vaccine ;
  5. the incidence of AE leading to withdrawal ;
  6. The incidence of AEs leading to withdrawal associated with the study vaccine. Incidence of all serious adverse events (SAEs), vaccine-related SAEs within 6 months after vaccination.

Immunogenicity endpoint: Primary endpoint:

Geometric mean titer (GMT) and positive conversion rate of neutralizing antibodies against the Omicron variant (BA.5) of the novel coronavirus in the study and control groups 14 days after the immunogenicity subgroup received the investigational vaccine.

Secondary endpoints:

  1. 14 days after the immunogenic subgroup of subjects received the investigational vaccine, the neutralizing antibody GMT, growth multiple (GMI), and positive conversion rate of the research group and the control group against the new coronavirus prototype strain and the Omicron variant (BF.7);
  2. 14 days after the immunogenicity subgroup of subjects received the investigational vaccine, the neutralizing antibody GMI of the research group and the control group against the new coronavirus Omicron variant (BA.5);
  3. 6 months after the immunogenicity subgroup received the investigational vaccine, the neutralizing antibody GMT, GMI, and positive conversion rate of the study group and the control group against the new coronavirus prototype strain and Omicron variant (BA.5, BF.7).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
450

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Anhui
      • Wuhu, Anhui, China, 241001
        • Wannan Medical College Yijishan Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  1. Be 18 years of age or older at the time of signing the informed consent form;
  2. 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;
  3. 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:

  1. 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.;
  2. fever (axillary body temperature≥ 37.3°C) within 72 hours before enrollment, or axillary body temperature ≥ 37.3°C on the day of enrollment;
  3. Patients infected with the new coronavirus within 3 months before enrollment (asymptomatic infection or positive nucleic acid or antigen test of the new coronavirus);
  4. Patients with aplastic anemia that has not been relieved, primary immune thrombocytopenia (ITP) active period, and uncontrolled coagulation diseases;
  5. 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;
  6. Non-live vaccine ≤ 14 days before vaccination and live attenuated vaccine 30 days before ≤vaccination;
  7. Patients with malignant tumors who are undergoing chemotherapy, radiotherapy, immunotherapy, etc. before and after surgery; Patients in the state of organ transplantation;
  8. Those suffering from uncontrolled epilepsy and other progressive neurological diseases (such as transverse myelitis, Guillain-Barre syndrome, demyelinating diseases, etc.);
  9. 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);
  10. 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Study Group
Intramuscular injection of 25μg/0.5ml Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) in the deltoid muscle of the upper arm.
Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)
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).
Active Comparator: Control group
Intramuscular injection of 25 μg/0.5 ml recombinant novel coronavirus protein vaccine (CHO cells) into the deltoid muscle of the upper arm.
Biological: Recombinant novel coronavirus protein vaccine (CHO cells)
Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Recombinant new coronavirus vaccine (CHO cells) .

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
The number of adverse events after intramuscular injection
Time Frame: 6 months after vaccination
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 vaccination
Laboratory markers of immunity
Time Frame: 14 days after vaccination
Geometric mean titer (GMT) of neutralizing antibodies against the Omicron variant (BA.5) after vaccination with the investigational vaccine.
14 days after vaccination
Immunogenic end points
Time Frame: 14 days after vaccination
Positive conversion rate of the Omicron variant (BA.5) of the new coronavirus after vaccination with the investigational vaccine.
14 days after vaccination

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Laboratory markers of immunity
Time Frame: 14 days after vaccination
Geometric mean titer (GMT) of neutralizing antibodies against the prototype strain of the new coronavirus, Omicron variant (BF.7) after vaccination with the investigational vaccine.
14 days after vaccination
Laboratory markers of immunity
Time Frame: 14 days after vaccination
Growth multiple (GMI) of the new coronavirus prototype strain and Omicron variant (BF.7) after vaccination with the investigational vaccine.
14 days after vaccination
Immunogenic end points
Time Frame: 14 days after vaccination
Positive conversion rate against the prototype strain of the new coronavirus, Omicron variant (BF.7) after vaccination with the investigational vaccine.
14 days after vaccination
Laboratory markers of immunity
Time Frame: 14 days after vaccination
Growth multiple (GMI) of the new coronavirus prototype strain and Omicron variant (BA.5) after vaccination with the investigational vaccine.
14 days after vaccination
Laboratory markers of immunity
Time Frame: 6 months after vaccination
Geometric mean titer (GMT) of neutralizing antibodies against the prototype strain of the new coronavirus, Omicron variant (BA.5, BF.7) after vaccination with the investigational vaccine.
6 months after vaccination
Laboratory markers of immunity
Time Frame: 6 months after vaccination
Growth multiple (GMI) of the new coronavirus prototype strain and Omicron variant (BA.5, BF.7) after vaccination with the investigational vaccine.
6 months after vaccination
Immunogenic end points
Time Frame: 6 months after vaccination
Positive conversion rate against the prototype strain of the new coronavirus and the Omicron variant (BA.5, BF.7) after vaccination with the investigational vaccine.
6 months after vaccination

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 17, 2023

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 17, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 20, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 7, 2023

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 6, 2023

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 9, 2023

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 13, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 9, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • LKM-2023-NCV-02

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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