Coronavirus Disease 2019NCT05089045
Immunogenicity and Safety Evaluation of Recombinant Novel Coronavirus Vaccine (CHO Cells) in Enhancing Immunity
A study testing Recombinant new coronavirus vaccine (CHO cell) group in people with Coronavirus Disease 2019, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
Popular topic: Clinical study on immunogenicity and safety evaluation of sequentially enhanced immunity with recombinant Novel Coronavirus vaccine (CHO cells) Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Coronavirus Disease 2019
- What is being tested?
- Recombinant new coronavirus vaccine (CHO cell) group
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- 31 Aug 2021to 30 Sep 2021
- 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
- Healthy subjects aged 18 and over with full civil capacity who can provide vaccination information proving that they have received two doses of Novel Coronavirus inactivated vaccine (Vero cells) in the last 3-13 months;
- Subjects voluntarily participate in the study, sign informed consent, provide valid identification, understand and comply with the requirements of the study protocol;
- Fertile men and women of reproductive age did not have sex from day 1 of the last menstrual cycle to day 1 of the study, or did not have sex with an effective contraceptive method and did not experience contraceptive failure (examples of contraceptive failure include male condom rupture during sex).Subjects also agreed to use effective contraception from the time of signing informed consent to 1 month after trial vaccination.
Who cannot join
- History of confirmed or asymptomatic coronavirus infection or positive nucleic acid test of novel Coronavirus infection;
- SARS virus history;
- Fever caused by any reason (such as cold, local inflammation, tumor, rheumatic immune disease, etc.) within 72 hours before enrollment, or armpit temperature ≥37.3℃ on the day of enrollment;
- history of severe allergic to any vaccine, or to test the vaccine's active ingredient, any a kind of active ingredients, use of material in the production process, including aluminum has a history of severe allergic, for example: the acute allergic reaction and allergic shock, allergic laryngeal edema, thrombocytopenic purpura, allergic purpura, difficulty breathing, angioneurotic oedema, etc;
- Persons suffering from the following diseases:
- ① Patients with stroke and encephalitis in the acute stage, patients with immune-related neurological diseases (such as myomyelitis, Guillanbarre syndrome, demyelinating disease, myasthenia gravis, etc.) that are not controlled, patients with epilepsy and severe mental illness, and patients with other neurological diseases that are not controlled;
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- ② Patients with acute respiratory infection, acute attack of chronic obstructive pulmonary disease, acute attack of bronchial asthma or clinical uncontrolled stage, acute stage of pleural disease, etc.;
- ③ systolic blood pressure ≤90mmHg and/or diastolic blood pressure ≤60mmHg of unknown cause;Hypertension treated with lifestyle adjustment and/or medication, systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg;Severe coronary heart disease, arrhythmia, heart rate less than 60 beats/min or more than 100 beats/min;Serious heart valve disease, aortic dissection, venous thrombosis;Patients with severe heart failure;Severe arrhythmia, or patients with acute coronary syndrome, acute aortic syndrome, etc.;
- ④ patients with acute pancreatitis, acute intestinal obstruction, acute hepatitis, patients with gastrointestinal bleeding symptoms, active stage of inflammatory bowel disease, active stage of chronic hepatitis, active stage of tuberculosis, etc.;
- ⑤ Patients with acute urinary and reproductive system infection, patients with severe kidney disease (uncontrolled acute and chronic nephritis, patients who are using glucocorticoids, immunosuppressants or biological agents, patients with acute renal insufficiency or chronic kidney disease stage 3 or more namely glomerular filtration rate eGFR\<60ml/min);
- ⑥ Diabetes patients with acute complications (remunerative acidosis, hyperotonic state, lactic acidosis) or with the above acute complications recovered less than 2 weeks;Fasting blood glucose > 13.9 mmol/L;Hypothyroidism TSH \& GT;10 µ IU/L, with T3 and T4 lower than normal;Patients with uncontrolled hyperthyroidism or hyperthyroidism;
- ⑦ lymphoproliferative disease uncontrolled period, aplastic anemia not alleviated period, primary immune thrombocytopenia (ITP) activity period, coagulation disease uncontrolled period and other patients;
- ⑧ Was immune system disease (systemic lupus erythematosus, rheumatoid arthritis, ankylosing spondylitis, sjogren's syndrome, etc.) in active patients, patients with congenital or acquired immunodeficiency, clear merge opportunistic infections or malignant tumors uncontrolled HIV infection, patients with lymphoma, leukemia or autoimmune inflammatory disease;
- ⑨ Patients with malignant tumor undergoing chemotherapy, radiotherapy, and immunotherapy before and after surgery;Patients with organ transplant status;
- ⑩ Patients with acute stage of severe allergic rhinitis, acute and chronic eczema or urticaria with obvious symptoms and signs, or patients with other skin symptoms;
- ⑪ The absence of spleen or history of splenic surgery;
- Receive immunomodulators within 6 months, such as immunosuppressive doses of glucocorticoids (dose reference: equivalent to prednisone 20mg/ day, over a week);Or monoclonal antibodies;Or thymosin;Or interferon;However, topical use (such as ointments, eye drops, inhalants or nasal sprays) is allowed;
- Have received blood or blood-related products, including immunoglobulin (including rabies immunoglobulin and tetanus immunoglobulin), within 3 months prior to experimental vaccine vaccination;Or planned use of the experimental vaccine within 1 month of vaccination;
- For those who have received rabies vaccine and tetanus vaccine and have not completed the course of vaccination, other subunit vaccines and inactivated vaccines shall be injected within 14 days before the experimental vaccine inoculation, and other live attenuated vaccines shall be injected within 30 days before the experimental vaccine inoculation;
- Women who are breastfeeding or pregnant (including women of childbearing age who have positive urine pregnancy test) or who plan to have a pregnancy within 1 month of the test vaccine or their partners;
- Have participated in or are participating in other COVID-19 related clinical trials, in addition to completing two doses of inactivated novel Coronavirus vaccine in the past 3-13 months;
- The Investigator believes that the subject has any disease or condition that may place the subject at unacceptable risk;Subjects cannot meet the requirements of the program;Conditions that interfere with the assessment of vaccine response.
Trial locations and contacts
1 site in 1 country.
China1 site
Hunan Provincial Center for Disease Control and Prevention
Changsha, Hunan, 411228
About this study
Official title: A Clinical Study to Evaluate the Immunogenicity and Safety of Recombinant New Coronavirus Vaccine (CHO Cells) After Vaccination With Two Inactivated Vaccine in Healthy People Aged 18 and Above
Popular topic: Clinical study on immunogenicity and safety evaluation of sequentially enhanced immunity with recombinant Novel Coronavirus vaccine (CHO cells) Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.Secondary purpose:To evaluate the safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.
Overall design:An open experimental design was used in this study Study population:The study involved people 18 years of age and older. Test groups: All subjects recruited must have received two doses of Novel Coronavirus inactivated vaccine for 3 to 13 months (the interval between booster and basic immunization is divided into 3 groups:120 subjects at 3-4 months (91-120 days), 6-8 months (181-240 days) and 11-13 months (331-390 days) were vaccinated with one dose of recombinant Novel Coronavirus vaccine (CHO cells).
Read the detailed description
Overall design: An open experimental design was adopted in this study, and 360 subjects were planned to be enrolled.To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.
Intervention: This study involved people 18 years of age and older.All subjects recruited must have received two doses of Novel Coronavirus inactivated vaccine for 3 to 13 months (the interval between booster and basic immunization is divided into 3 groups:120 subjects at 3-4 months (91-120 days), 6-8 months (181-240 days) and 11-13 months (331-390 days) were vaccinated with one dose of recombinant Novel Coronavirus vaccine (CHO cells).
Immunogenicity observation:
Blood samples were collected from all subjects before and 14 days after experimental vaccine vaccination for humoral immunoassay.
Safety observation:
AE and SAE:
Collect all adverse events (AE) at least 30 minutes after vaccination, all AE (both solicitation and non-solicitation AE) from 0 to 7 days, and all AE (non-solicitation AE) from 8 to 30 days;All serious adverse events (SAE) within 1 month after vaccination with the experimental vaccine were collected.
- Solicitation AE (the following events occurring within 0-7 days after vaccination with experimental vaccine) :Adverse events at the inoculation site (local) : pain, itching, redness, swelling, rash, induration; Non-inoculated site (systemic) adverse events: fever, headache, fatigue/fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute allergic reaction, cough.
- Vital signs and physical examination:All subjects were assessed for vital signs (blood pressure, axillary body temperature, pulse) during screening and axillary body temperature before trial vaccination. All subjects underwent physical examination (skin, cardiopulmonary auscultation) during the screening period.
- Collection of pregnancy events:Women of childbearing age should undergo a urine pregnancy test before enrollment (on the day of vaccination). Pregnancy events occurring within 1 month after trial vaccination were collected.
- ADE/VED (Antibody enhancement/vaccine Enhancement) Risk Monitoring:After receiving the experimental vaccine, if the subject is diagnosed with COVID-19, he/she should go to the hospital for hospitalization or be isolated in accordance with the local epidemic prevention and control requirements.A special investigation will be conducted for severe/critical/fatal cases, and the existence of ADE/VED will be analyzed based on the results of the special investigation.
- Conditions
- Coronavirus Disease 2019
- Being tested
- Recombinant new coronavirus vaccine (CHO cell) group
- Keywords
- Recombinant Novel Coronavirus Vaccine
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Recombinant new coronavirus vaccine (CHO cell) groupBiological
Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
| Study group | Role | What they receive |
|---|---|---|
| Population Ⅰ | Experimental | Not described Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) group |
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 main observation methods of adverse reactions mainly include local reactions and systemic reactions at the administration site.
Measured: 1 months after full vaccination
Immunogenic end point
GMT and positive rate of SARS-COV-2 neutralizing antibody 14 days after vaccination with recombinant Novel Coronavirus vaccine (CHO cells)
Measured: 14 days after vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Oct 2021
- Study start31 Aug 2021
- Primary completion16 Sep 2021
- Study completion30 Sep 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Coronavirus Disease 2019Studies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 360 participants (actual)
Sponsor and investigators
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tao Huang, Principal investigator, Hunan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05089045
- Sponsor's protocol ID
- LKM-2021-NCV04
- Status last verified
- Oct 2021
- First submitted
- 11 Oct 2021
- Last updated
- 22 Oct 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Oct 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Immunogenicity and Safety of Recombinant New Coronavirus Vaccine (CHO Cells) After Vaccination With Two Inactivated Vaccine in Healthy People Aged 18 and Above
- ClinicalTrials.gov ID
- NCT05089045
- Acronym / sponsor ID
- LKM-2021-NCV04
- Conditions
- Coronavirus Disease 2019
- Keywords
- Recombinant Novel Coronavirus Vaccine
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 360 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 31 Aug 2021 (actual)
- Primary completion
- 16 Sep 2021 (actual)
- Study completion
- 30 Sep 2021 (actual)
- First posted
- 22 Oct 2021 (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 topic: Clinical study on immunogenicity and safety evaluation of sequentially enhanced immunity with recombinant Novel Coronavirus vaccine (CHO cells) Research purpose:Main purpose:To evaluate the immunogenicity of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.Secondary purpose:To evaluate the safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.
Overall design:An open experimental design was used in this study Study population:The study involved people 18 years of age and older. Test groups: All subjects recruited must have received two doses of Novel Coronavirus inactivated vaccine for 3 to 13 months (the interval between booster and basic immunization is divided into 3 groups:120 subjects at 3-4 months (91-120 days), 6-8 months (181-240 days) and 11-13 months (331-390 days) were vaccinated with one dose of recombinant Novel Coronavirus vaccine (CHO cells).
Detailed description
Overall design: An open experimental design was adopted in this study, and 360 subjects were planned to be enrolled.To evaluate the immunogenicity and safety of recombinant Novel Coronavirus vaccine (CHO cells) after sequential booster immunization in populations vaccinated with two doses of marketed Novel Coronavirus inactivated vaccine.
Intervention: This study involved people 18 years of age and older.All subjects recruited must have received two doses of Novel Coronavirus inactivated vaccine for 3 to 13 months (the interval between booster and basic immunization is divided into 3 groups:120 subjects at 3-4 months (91-120 days), 6-8 months (181-240 days) and 11-13 months (331-390 days) were vaccinated with one dose of recombinant Novel Coronavirus vaccine (CHO cells).
Immunogenicity observation:
Blood samples were collected from all subjects before and 14 days after experimental vaccine vaccination for humoral immunoassay.
Safety observation:
AE and SAE:
Collect all adverse events (AE) at least 30 minutes after vaccination, all AE (both solicitation and non-solicitation AE) from 0 to 7 days, and all AE (non-solicitation AE) from 8 to 30 days;All serious adverse events (SAE) within 1 month after vaccination with the experimental vaccine were collected.
- Solicitation AE (the following events occurring within 0-7 days after vaccination with experimental vaccine) :Adverse events at the inoculation site (local) : pain, itching, redness, swelling, rash, induration; Non-inoculated site (systemic) adverse events: fever, headache, fatigue/fatigue, diarrhea, nausea, vomiting, muscle pain (non-inoculated site), acute allergic reaction, cough.
- Vital signs and physical examination:All subjects were assessed for vital signs (blood pressure, axillary body temperature, pulse) during screening and axillary body temperature before trial vaccination. All subjects underwent physical examination (skin, cardiopulmonary auscultation) during the screening period.
- Collection of pregnancy events:Women of childbearing age should undergo a urine pregnancy test before enrollment (on the day of vaccination). Pregnancy events occurring within 1 month after trial vaccination were collected.
- ADE/VED (Antibody enhancement/vaccine Enhancement) Risk Monitoring:After receiving the experimental vaccine, if the subject is diagnosed with COVID-19, he/she should go to the hospital for hospitalization or be isolated in accordance with the local epidemic prevention and control requirements.A special investigation will be conducted for severe/critical/fatal cases, and the existence of ADE/VED will be analyzed based on the results of the special investigation.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Population Ⅰ | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell) group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy subjects aged 18 and over with full civil capacity who can provide vaccination information proving that they have received two doses of Novel Coronavirus inactivated vaccine (Vero cells) in the last 3-13 months;
- Subjects voluntarily participate in the study, sign informed consent, provide valid identification, understand and comply with the requirements of the study protocol;
- Fertile men and women of reproductive age did not have sex from day 1 of the last menstrual cycle to day 1 of the study, or did not have sex with an effective contraceptive method and did not experience contraceptive failure (examples of contraceptive failure include male condom rupture during sex).Subjects also agreed to use effective contraception from the time of signing informed consent to 1 month after trial vaccination.
Key exclusion criteria (22 listed)
- History of confirmed or asymptomatic coronavirus infection or positive nucleic acid test of novel Coronavirus infection;
- SARS virus history;
- Fever caused by any reason (such as cold, local inflammation, tumor, rheumatic immune disease, etc.) within 72 hours before enrollment, or armpit temperature ≥37.3℃ on the day of enrollment;
- history of severe allergic to any vaccine, or to test the vaccine's active ingredient, any a kind of active ingredients, use of material in the production process, including aluminum has a history of severe allergic, for example: the acute allergic reaction and allergic shock, allergic laryngeal edema, thrombocytopenic purpura, allergic purpura, difficulty breathing, angioneurotic oedema, etc;
- Persons suffering from the following diseases:
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 |
|---|---|---|
| Recombinant new coronavirus vaccine (CHO cell) groupIntramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). | Biological | Population Ⅰ |
Primary outcome
The number of adverse events after intramuscular injection
Time frame: 1 months after full vaccination
The main observation methods of adverse reactions mainly include local reactions and systemic reactions at the administration site.
Immunogenic end point
Time frame: 14 days after vaccination
GMT and positive rate of SARS-COV-2 neutralizing antibody 14 days after vaccination with recombinant Novel Coronavirus vaccine (CHO cells)
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 22 Oct 2021.
- Individual participant dataSharing planned: No
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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.
Tao Huang principal investigator
Hunan Provincial Center for Disease Control and Prevention
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Recombinant new coronavirus vaccine (CHO cell) group in people with Coronavirus Disease 2019, 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 22 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 22 Oct 2021. 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: 1 months after full vaccination). The study lists 2 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 22 Oct 2021.