CoronavirusNCT06025812
Clinical Study of Omicron BA.4/5-Delta Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells)
A study testing Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) and Recombinant novel coronavirus protein vaccine (CHO cells) in people with Coronavirus, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd..
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus
- What is being tested?
- Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) and Recombinant novel coronavirus protein vaccine (CHO cells)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 160 participants
- Where
- No sites listed yet
- Study dates
- 20 Sep 2023to 30 Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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
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.
Read more
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.
- Conditions
- Coronavirus
- Being tested
- Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells), Recombinant novel coronavirus protein vaccine (CHO cells)
- Keywords
- Omicron BA.4/5-Delta strain
- Medical subject headings
- Coronavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)Biological
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).
Recombinant novel coronavirus protein vaccine (CHO cells)Biological
Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person dose Recombinant new coronavirus vaccine (CHO cells).
| Study group | Role | What they receive |
|---|---|---|
| 0-1-month immune program study group | Experimental | 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. Receives: Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) |
| 0-1-month immune program control group | Active comparator | 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. Receives: Biological: Recombinant novel coronavirus protein vaccine (CHO cells) |
| 0-6-month immune program study group | Experimental | 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. Receives: Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) |
| 0-6-month immune program control group | Active comparator | 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. Receives: Biological: Recombinant novel coronavirus protein vaccine (CHO cells) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 14 days after 2 doses of vaccine
Secondary outcomes (7)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 6 months after 2 doses of vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2023
- Study start20 Sep 2023 (estimated)
- Primary completion15 May 2024 (estimated)
- Study completion30 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CoronavirusStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06025812
- Sponsor's protocol ID
- LKM-2023-NCV-05
- Status last verified
- Aug 2023
- First submitted
- 30 Aug 2023
- Last updated
- 6 Sep 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06025812
- Acronym / sponsor ID
- LKM-2023-NCV-05
- Conditions
- Coronavirus
- Keywords
- Omicron BA.4/5-Delta strain
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Sep 2023 (estimated)
- Primary completion
- 15 May 2024 (estimated)
- Study completion
- 30 Jun 2024 (estimated)
- First posted
- 6 Sep 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 0-1-month immune program study group | Experimental | Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)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. |
| 0-1-month immune program control group | Active comparator | Biological: Recombinant novel coronavirus protein vaccine (CHO cells)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. |
| 0-6-month immune program study group | Experimental | Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)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. |
| 0-6-month immune program control group | Active comparator | Biological: Recombinant novel coronavirus protein vaccine (CHO cells)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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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). | Biological | 0-1-month immune program study group, 0-6-month immune program study group |
| 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). | Biological | 0-1-month immune program control group, 0-6-month immune program control group |
Primary outcome
Number of adverse events after 2 doses given intramuscularly according to different immunization programs
Time frame: 6 months after 2 doses of vaccine
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.
Laboratory markers of immunity after 2 doses given intramuscularly according to different immunization programs
Time frame: 14 days after 2 doses of vaccine
Geometric mean titer (GMT) of neutralizing antibodies against the Omicron variant (XBB) after vaccination with the investigational vaccine.
Immunogenic end points
Time frame: 14 days after 2 doses of vaccine
Positive conversion rate of the Omicron variant (XBB) of the new coronavirus after vaccination with the investigational vaccine.
7 secondary outcomes
Laboratory markers of immunity
Time frame: 14 days after 2 doses of vaccine
Laboratory markers of immunity
Time frame: 14 days after 2 doses of vaccine
Immunogenic end points
Time frame: 14 days after 2 doses of vaccine
Laboratory markers of immunity
Time frame: 14 days after 2 doses of vaccine
Laboratory markers of immunity
Time frame: 6 months after 2 doses of vaccine
Laboratory markers of immunity
Time frame: 6 months after 2 doses of vaccine
Immunogenic end points
Time frame: 6 months after 2 doses of vaccine
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) and Recombinant novel coronavirus protein vaccine (CHO cells) in people with Coronavirus, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd..
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Xie Hai Tang (0553-5738350, xiehaitang@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events after 2 doses given intramuscularly according to different immunization programs (time frame: 6 months after 2 doses of vaccine). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.