COVID-19Phase 2NCT05109598
Clinical Trial of Immunogenicity Bridging of a Recombinant New Coronavirus（COVID-19） Vaccine (CHO Cell)
A Phase 2 study testing Recombinant new coronavirus vaccine (CHO cell) in people with COVID-19, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
Popular topic: A clinical trial comparing the immunogenicity of recombinant New Coronavirus vaccine (CHO cells) among people aged 3 to 17 and 18 to 59 years of age. Overall design:Non inferiority test design was used to evaluate the immunogenicity of the vaccine inoculated to the age group of 3~17 and the age of… Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- COVID-19
- What is being tested?
- Recombinant new coronavirus vaccine (CHO cell)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteChina
- Study dates
- 4 Nov 2021to 6 Apr 2023
- Phase
- Phase 2
- 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 3 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- At least 3 ~ 17 years old (both included);
- The subject voluntarily agrees to participate in the study, and / or the guardian of the subject voluntarily agrees to the child to participate in the study. The subject himself (8-17 years old) and the guardian sign the informed consent form, and can provide valid identity certificates to understand and comply with the requirements of the test protocol;
- The subject and / or the guardian of the subject have the ability to understand (non illiterate) the research procedures and promise to participate in regular follow-up according to the research requirements;
- There is no high or medium risk area, overseas travel history or residence history in the past 14 days; In the past 14 days, no confirmed case of New Coronavirus infection, asymptomatic infection or suspected cases had been found. And there was no contact history of patients with fever or respiratory symptoms from high and medium risk areas in the past 14 days; Personnel in non isolation period;
- Male and female subjects with fertility agreed to take effective contraceptive measures from the beginning of the study to 2 months after the whole vaccination.
Who cannot join
- The results of physical examination during screening period are abnormal and clinically significant (not suitable for vaccination) as determined by clinicians;
- Suspected or confirmed fever within 72 hours before enrollment (including the day of enrollment) (> 14 years old, axillary temperature ≥ 37.3 ℃; ≤ 14 years old, axillary temperature ≥ 37.5 ℃);
- Have a history of severe allergy to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema, etc; Or have a history of the above serious side effects after the use of any vaccine or drug in the past;
- had previous history of SARS and SARS-CoV-2.
- Taking antipyretics or painkillers within 24 hours before the first dose of vaccine;
- persons who have been vaccinated with New Coronavirus or inoculated with live attenuated vaccine within 7 days or within 7 days before the first dose of vaccine are inoculated with inward subunit vaccine and / or inactivated vaccine.
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- Have received blood or blood related products, including immunoglobulin, within 3 months before the vaccination of the test vaccine; Or planned use during the study;
- Persons suffering from the following diseases:
- ① Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days;
- ② Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
- ③ History of congenital or acquired immune deficiency or autoimmune diseases or receiving immunomodulator treatment within 6 months, such as immunosuppressive dose of Glucocorticoid (dose reference: equivalent to prednisone 20mg / day, more than one week); Or monoclonal antibody; Or thymosin; Or interferon, etc; However, topical medication (such as ointment, eye drops, inhalants or nasal sprays) is allowed;
- ④ It is known that it is diagnosed with infectious diseases, such as active tuberculosis, viral hepatitis present, human immunodeficiency virus infection or Treponema pallidum infection.
- ⑤ Neurological diseases or neurodysplasia (e.g., convulsions, migraines, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficit, Guillain Barre syndrome, encephalomyelitis or transverse myelitis); History of psychosis or family history;
- ⑥ Functional absence of spleen, and absence of spleen or splenectomy for any reason;
- ⑦ There are serious chronic diseases or disease in progress can not be controlled smoothly, such as diabetes, drugs can not control hypertension.
- ⑧ Severe liver and kidney diseases; Respiratory diseases that currently require daily drug treatment (e.g., chronic obstructive pulmonary disease [COPD], asthma) or any treatment for aggravation of respiratory diseases (e.g., aggravation of asthma) in the last 5 years; A history of serious cardiovascular disease (such as congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, cor pulmonale) or myocarditis or pericarditis;
- ⑨ Thrombocytopenia, any coagulation dysfunction or anticoagulant treatment;
- ⑩ Cancer patients (except basal cell carcinoma);
- Lactating women or pregnant women (including women of childbearing age with positive urine pregnancy test), or women or their partners who have pregnancy plans within 2 months after the whole vaccination of the test vaccine;
- Those who have participated or are participating in other clinical trials, and the relevant visits have not been completed, or are clearly vaccinated after the completion of the new crown vaccine;
- The researcher believes that the subject has any disease or condition that may put the subject at unacceptable risk; The subjects were unable to meet the protocol requirements; Interference with the evaluation 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 Trial Comparing the Immunogenicity of Recombinant New Coronavirus Vaccine (CHO Cells) Among People Aged 3 to 17 and 18 to 59 Years of Age.
Popular topic: A clinical trial comparing the immunogenicity of recombinant New Coronavirus vaccine (CHO cells) among people aged 3 to 17 and 18 to 59 years of age.
Overall design:Non inferiority test design was used to evaluate the immunogenicity of the vaccine inoculated to the age group of 3~17 and the age of 18~59. The non inferiority hypothesis test was conducted with the results of immunogenicity of the 18-59 year old group in China in the phase III clinical trial of recombinant New Coronavirus vaccine (CHO cell).
Study population:400 healthy people aged 3 to 17 years old, both male and female.
Read the detailed description
Study population:A total of 400 healthy people aged 3 ~ 17 were enrolled (including 130 cases aged 3 ~ 5, 150 cases aged 6 ~ 11, and 120 cases aged 12 ~ 17)，both male and female.
Overall design:Non inferiority test design was used to evaluate the immunogenicity of the vaccine inoculated to the age group of 3~17 and the age of 18~59. The non inferiority hypothesis test was conducted with the results of immunogenicity of the 18-59 year old group in China in the phase III clinical trial of recombinant New Coronavirus vaccine (CHO cell).
Immunization program: Three doses were inoculated in 0, 1 and 2 months. Dose:25μg/0.5mL/dose.
Safety endpoint:
- AE and SAE:Collect all adverse events (AES) 30 minutes after each dose of vaccination, all AES 0-7 days (including solicited and non solicited AES), all AES 8-30 days (non solicited AES), and all SAE from the first dose of vaccination to 12 months after the whole course of immunization.
- Vital signs and physical examination: All subjects underwent axillary temperature examination every day during the screening period, before the next dose of vaccination and within 7 days after each dose of vaccination. All subjects underwent physical examination (skin and cardiopulmonary auscultation) during the screening period.
- Pregnancy events: For women of childbearing age, urine pregnancy test should be carried out before each dose of vaccination. The pregnancy events occurred within 12 months from the first dose of vaccine to the whole course of immunization were collected.
- ADE / VED risk monitoring:
After vaccination (at least one dose of test vaccine) (at each visit), remind the subjects to contact the investigator in time for fever and / or respiratory symptoms (such as dyspnea, sore throat, etc.) and covid-19 suspected or confirmed cases during the study. If the subject is suspected or confirmed to be infected with sars-cov-2 during the test, he must go to the local Xinguan designated hospital for hospitalization diagnosis and treatment. Detailed case investigation shall be conducted for confirmed cases. In case of severe or dead cases of new crown infection, an expert meeting shall be held to conduct special investigation and evaluate whether it is ADE/ VED.
- Conditions
- COVID-19
- Being tested
- Recombinant new coronavirus vaccine (CHO cell)
- 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)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 |
|---|---|---|
| Population I | Experimental | Population I has 400 subjects aged 3 to 17 who were recruited by this trial. Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) |
| Population II | Experimental | Population II will use 400 subjects aged of 18-59 in the phase III clinical trial in China whose blood has been collected. Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immunogenic end point
The positive rate of sars-cov-2 neutralizing antibody, RBD protein binding antibody (IgG) GMT and 14 days after the whole course immunization of the test vaccine in the target population.
Measured: 14 days after full vaccination
The number of adverse events after intramuscular injection
All adverse events (AE) from the first dose to 1 month after the whole course of immunization
Measured: from the first dose to 1 month after the whole course of immunization
The number of serious adverse events after intramuscular injection
Incidence of all serious adverse events (SAE) and vaccine related SAE from the first dose to 12 months after the whole course of vaccination.
Measured: from the first dose to 12 months after the whole course of vaccination.
Secondary outcomes (1)
Immunopersistence results
The positive rate of sars-cov-2 neutralizing antibody, RBD protein binding antibody (IgG) GMT and 6 months after the whole course immunization of the test vaccine in the target population.
Measured: 6 months after the last dose of vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start4 Nov 2021
- Primary completion14 Feb 2022
- Study completion6 Apr 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies 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 2
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 400 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, Study director, Hunan Provincial Center for Disease Control and Prevention
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109598
- Sponsor's protocol ID
- LKM-2021-NCV03
- Status last verified
- Apr 2023
- First submitted
- 4 Nov 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Gao L, Li Y, He P, Chen Z, Yang H, Li F, Zhang S, Wang D, Wang G, Yang S, Gong L, Ding F, Ling M, Wang X, Ci L, Dai L, Gao GF, Huang T, Hu Z, Ying Z, Sun J, Zuo X. Safety and immunogenicity of a protein subunit COVID-19 vaccine (ZF2001) in healthy children and adolescents aged 3-17 years in China: a randomised, double-blind, placebo-controlled, phase 1 trial and an open-label, non-randomised, non-inferiority, phase 2 trial. Lancet Child Adolesc Health. 2023 Apr;7(4):269-279. doi: 10.1016/S2352-4642(22)00376-5. Epub 2023 Feb 17.
PubMed 36803632
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Trial Comparing the Immunogenicity of Recombinant New Coronavirus Vaccine (CHO Cells) Among People Aged 3 to 17 and 18 to 59 Years of Age.
- ClinicalTrials.gov ID
- NCT05109598
- Acronym / sponsor ID
- LKM-2021-NCV03
- Conditions
- COVID-19
- Keywords
- Recombinant Novel Coronavirus Vaccine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 400 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2021 (actual)
- Primary completion
- 14 Feb 2022 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 5 Nov 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: A clinical trial comparing the immunogenicity of recombinant New Coronavirus vaccine (CHO cells) among people aged 3 to 17 and 18 to 59 years of age.
Overall design:Non inferiority test design was used to evaluate the immunogenicity of the vaccine inoculated to the age group of 3~17 and the age of 18~59. The non inferiority hypothesis test was conducted with the results of immunogenicity of the 18-59 year old group in China in the phase III clinical trial of recombinant New Coronavirus vaccine (CHO cell).
Study population:400 healthy people aged 3 to 17 years old, both male and female.
Detailed description
Study population:A total of 400 healthy people aged 3 ~ 17 were enrolled (including 130 cases aged 3 ~ 5, 150 cases aged 6 ~ 11, and 120 cases aged 12 ~ 17)，both male and female.
Overall design:Non inferiority test design was used to evaluate the immunogenicity of the vaccine inoculated to the age group of 3~17 and the age of 18~59. The non inferiority hypothesis test was conducted with the results of immunogenicity of the 18-59 year old group in China in the phase III clinical trial of recombinant New Coronavirus vaccine (CHO cell).
Immunization program: Three doses were inoculated in 0, 1 and 2 months. Dose:25μg/0.5mL/dose.
Safety endpoint:
- AE and SAE:Collect all adverse events (AES) 30 minutes after each dose of vaccination, all AES 0-7 days (including solicited and non solicited AES), all AES 8-30 days (non solicited AES), and all SAE from the first dose of vaccination to 12 months after the whole course of immunization.
- Vital signs and physical examination: All subjects underwent axillary temperature examination every day during the screening period, before the next dose of vaccination and within 7 days after each dose of vaccination. All subjects underwent physical examination (skin and cardiopulmonary auscultation) during the screening period.
- Pregnancy events: For women of childbearing age, urine pregnancy test should be carried out before each dose of vaccination. The pregnancy events occurred within 12 months from the first dose of vaccine to the whole course of immunization were collected.
- ADE / VED risk monitoring:
After vaccination (at least one dose of test vaccine) (at each visit), remind the subjects to contact the investigator in time for fever and / or respiratory symptoms (such as dyspnea, sore throat, etc.) and covid-19 suspected or confirmed cases during the study. If the subject is suspected or confirmed to be infected with sars-cov-2 during the test, he must go to the local Xinguan designated hospital for hospitalization diagnosis and treatment. Detailed case investigation shall be conducted for confirmed cases. In case of severe or dead cases of new crown infection, an expert meeting shall be held to conduct special investigation and evaluate whether it is ADE/ VED.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Population I | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell)Population I has 400 subjects aged 3 to 17 who were recruited by this trial. |
| Population II | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell)Population II will use 400 subjects aged of 18-59 in the phase III clinical trial in China whose blood has been collected. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- At least 3 ~ 17 years old (both included);
- The subject voluntarily agrees to participate in the study, and / or the guardian of the subject voluntarily agrees to the child to participate in the study. The subject himself (8-17 years old) and the guardian sign the informed consent form, and can provide valid identity certificates to understand and comply with the requirements of the test protocol;
- The subject and / or the guardian of the subject have the ability to understand (non illiterate) the research procedures and promise to participate in regular follow-up according to the research requirements;
- There is no high or medium risk area, overseas travel history or residence history in the past 14 days; In the past 14 days, no confirmed case of New Coronavirus infection, asymptomatic infection or suspected cases had been found. And there was no contact history of patients with fever or respiratory symptoms from high and medium risk areas in the past 14 days; Personnel in non isolation period;
- Male and female subjects with fertility agreed to take effective contraceptive measures from the beginning of the study to 2 months after the whole vaccination.
Key exclusion criteria (21 listed)
- The results of physical examination during screening period are abnormal and clinically significant (not suitable for vaccination) as determined by clinicians;
- Suspected or confirmed fever within 72 hours before enrollment (including the day of enrollment) (> 14 years old, axillary temperature ≥ 37.3 ℃; ≤ 14 years old, axillary temperature ≥ 37.5 ℃);
- Have a history of severe allergy to any component of the test vaccine, including aluminum preparation, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, dyspnea, angioneurotic edema, etc; Or have a history of the above serious side effects after the use of any vaccine or drug in the past;
- had previous history of SARS and SARS-CoV-2.
- Taking antipyretics or painkillers within 24 hours before the first dose of vaccine;
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)Intramuscular injection of deltoid muscle of upper arm of 25μg/0.5ml/person /dose Recombinant new coronavirus vaccine (CHO cells). | Biological | Population I, Population II |
Primary outcome
Immunogenic end point
Time frame: 14 days after full vaccination
The positive rate of sars-cov-2 neutralizing antibody, RBD protein binding antibody (IgG) GMT and 14 days after the whole course immunization of the test vaccine in the target population.
The number of adverse events after intramuscular injection
Time frame: from the first dose to 1 month after the whole course of immunization
All adverse events (AE) from the first dose to 1 month after the whole course of immunization
The number of serious adverse events after intramuscular injection
Time frame: from the first dose to 12 months after the whole course of vaccination.
Incidence of all serious adverse events (SAE) and vaccine related SAE from the first dose to 12 months after the whole course of vaccination.
1 secondary outcome
Immunopersistence results
Time frame: 6 months after the last dose of 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 25 Apr 2023.
- Derived from this study: PubMed 36803632Gao L, Li Y, He P, Chen Z, Yang H, Li F, Zhang S, Wang D, Wang G, Yang S, Gong L, Ding F, Ling M, Wang X, Ci L, Dai L, Gao GF, Huang T, Hu Z, Ying Z, Sun J, Zuo X. Safety and immunogenicity of a protein subunit COVID-19 vaccine (ZF2001) in healthy children and adolescents aged 3-17 years in China: a randomised, double-blind, placebo-controlled, phase 1 trial and an open-label, non-randomised, non-inferiority, phase 2 trial. Lancet Child Adolesc Health. 2023 Apr;7(4):269-279. doi: 10.1016/S2352-4642(22)00376-5. Epub 2023 Feb 17.
- 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 study director
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 Phase 2 study testing Recombinant new coronavirus vaccine (CHO cell) in people with COVID-19, 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 5 inclusion and 21 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 25 Apr 2023. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Immunogenic end point (time frame: 14 days after full 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 NCT05109598, which also lists 1 linked publication.
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 25 Apr 2023.