CoronavirusNCT05850507
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. at 1 site in China.
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
- 450 participants
- Where
- 1 siteChina
- Study dates
- 17 Mar 2023to 20 Mar 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
1 site in 1 country.
About this study
Official title: 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.
Read more
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.
Read the 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:
- Incidence of all AEs within 30 days of vaccination:
- incidence of total AE ;
- the incidence of AEs associated with the study vaccine ;
- Grade 3 and above AE incidence ;
- incidence of grade 3 and above AEs associated with the investigational vaccine ;
- the incidence of AE leading to withdrawal ;
- 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:
- 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);
- 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);
- 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).
- 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 |
|---|---|---|
| Study Group | Experimental | 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. Receives: Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells) |
| Control group | Active comparator | Intramuscular injection of 25 μg/0.5 ml recombinant novel coronavirus protein vaccine (CHO cells) into the deltoid muscle of the upper arm. 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.
The number of adverse events after intramuscular injection
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 vaccination
Laboratory markers of immunity
Geometric mean titer (GMT) of neutralizing antibodies against the Omicron variant (BA.5) after vaccination with the investigational vaccine.
Measured: 14 days after vaccination
Immunogenic end points
Positive conversion rate of the Omicron variant (BA.5) of the new coronavirus after vaccination with the investigational vaccine.
Measured: 14 days after vaccination
Secondary outcomes (7)
Laboratory markers of immunity
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.
Measured: 14 days after vaccination
Laboratory markers of immunity
Growth multiple (GMI) of the new coronavirus prototype strain and Omicron variant (BF.7) after vaccination with the investigational vaccine.
Measured: 14 days after vaccination
Immunogenic end points
Positive conversion rate against the prototype strain of the new coronavirus, Omicron variant (BF.7) after vaccination with the investigational vaccine.
Measured: 14 days after vaccination
Laboratory markers of immunity
Growth multiple (GMI) of the new coronavirus prototype strain and Omicron variant (BA.5) after vaccination with the investigational vaccine.
Measured: 14 days after vaccination
Laboratory markers of immunity
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.
Measured: 6 months after vaccination
Laboratory markers of immunity
Growth multiple (GMI) of the new coronavirus prototype strain and Omicron variant (BA.5, BF.7) after vaccination with the investigational vaccine.
Measured: 6 months after vaccination
Immunogenic end points
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.
Measured: 6 months after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 May 2023
- Study start17 Mar 2023
- Primary completion17 Oct 2023
- Study completion20 Mar 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 450 participants (actual)
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
- NCT05850507
- Sponsor's protocol ID
- LKM-2023-NCV-02
- Status last verified
- May 2023
- First submitted
- 7 Apr 2023
- Last updated
- 13 May 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Hu H, Ma F, Gong L, Wang Y, Xu M, Sun H, Hu Q, Wang P, Han L, Xie H. Immunogenicity and safety of a recombinant Omicron BA.4/5-Delta COVID-19 vaccine ZF2202-A in Chinese adults. Vaccine. 2024 May 31;42(15):3522-3528. doi: 10.1016/j.vaccine.2024.04.058. Epub 2024 May 3.
PubMed 38704251He Q, An Y, Zhou X, Xie H, Tao L, Li D, Zheng A, Li L, Xu Z, Yu S, Wang R, Hu H, Liu K, Wang Q, Dai L, Xu K, Gao GF. Neutralization of EG.5, EG.5.1, BA.2.86, and JN.1 by antisera from dimeric receptor-binding domain subunit vaccines and 41 human monoclonal antibodies. Med. 2024 May 10;5(5):401-413.e4. doi: 10.1016/j.medj.2024.03.006. Epub 2024 Apr 3.
PubMed 38574739
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2024. 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 Strain Recombinant Novel Coronavirus Protein Vaccine (CHO Cells) in People 18 Years of Age and Older
- ClinicalTrials.gov ID
- NCT05850507
- Acronym / sponsor ID
- LKM-2023-NCV-02
- Conditions
- Coronavirus
- Keywords
- Omicron BA.4/5-Delta strain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 17 Mar 2023 (actual)
- Primary completion
- 17 Oct 2023 (actual)
- Study completion
- 20 Mar 2024 (actual)
- First posted
- 9 May 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 (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.
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:
- Incidence of all AEs within 30 days of vaccination:
- incidence of total AE ;
- the incidence of AEs associated with the study vaccine ;
- Grade 3 and above AE incidence ;
- incidence of grade 3 and above AEs associated with the investigational vaccine ;
- the incidence of AE leading to withdrawal ;
- 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:
- 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);
- 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);
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Study Group | Experimental | Biological: Omicron BA.4/5-Delta strain recombinant novel coronavirus protein vaccine (CHO cells)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. |
| Control group | Active comparator | Biological: Recombinant novel coronavirus protein vaccine (CHO cells)Intramuscular injection of 25 μg/0.5 ml recombinant novel coronavirus protein vaccine (CHO cells) into the deltoid muscle of the upper arm. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 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 | 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 | Control group |
Primary outcome
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.
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.
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.
7 secondary outcomes
Laboratory markers of immunity
Time frame: 14 days after vaccination
Laboratory markers of immunity
Time frame: 14 days after vaccination
Immunogenic end points
Time frame: 14 days after vaccination
Laboratory markers of immunity
Time frame: 14 days after vaccination
Laboratory markers of immunity
Time frame: 6 months after vaccination
Laboratory markers of immunity
Time frame: 6 months after vaccination
Immunogenic end points
Time frame: 6 months after vaccination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2024.
- Derived from this study: PubMed 38704251Hu H, Ma F, Gong L, Wang Y, Xu M, Sun H, Hu Q, Wang P, Han L, Xie H. Immunogenicity and safety of a recombinant Omicron BA.4/5-Delta COVID-19 vaccine ZF2202-A in Chinese adults. Vaccine. 2024 May 31;42(15):3522-3528. doi: 10.1016/j.vaccine.2024.04.058. Epub 2024 May 3.
- Derived from this study: PubMed 38574739He Q, An Y, Zhou X, Xie H, Tao L, Li D, Zheng A, Li L, Xu Z, Yu S, Wang R, Hu H, Liu K, Wang Q, Dai L, Xu K, Gao GF. Neutralization of EG.5, EG.5.1, BA.2.86, and JN.1 by antisera from dimeric receptor-binding domain subunit vaccines and 41 human monoclonal antibodies. Med. 2024 May 10;5(5):401-413.e4. doi: 10.1016/j.medj.2024.03.006. Epub 2024 Apr 3.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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. at 1 site in China.
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 3 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: finished, as of the sponsor's last update on 13 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of adverse events after intramuscular injection (time frame: 6 months after vaccination). 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?
On the ClinicalTrials.gov record for NCT05850507, which also lists 2 linked publications.
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 13 May 2024.