CoronavirusPhase 1NCT04961359
Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2（COVID-19） Phase I Clinical Trial (3~17 Years Old)
A Phase 1 study testing Recombinant new coronavirus vaccine (CHO cell) group in people with Coronavirus, run by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd. at 1 site in China.
Trial summary
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (3~17 years old) Research purpose:Main purpose:To evaluate the safety and tolerability of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17. Read more about this study
- Who is it for?
- Ages 3 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Coronavirus
- What is being tested?
- Recombinant new coronavirus vaccine (CHO cell) group
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 3 Jul 2021to 6 Apr 2023
- Phase
- Phase 1
- 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
- Aged 3-17 years old (all inclusive);
- The subject voluntarily agrees to participate in the study (or the legal guardian of the subject voluntarily agrees the child to participate in the study), and the guardian and the subject (8-17 years old) sign the informed consent form, and can provide valid identification; Understand and comply with test protocol requirements;
- The subject and / or the legal guardian of the subject have the ability to understand the (non illiterate) study procedure and participate in the planned follow-up;
- Axillary temperature < 37.3 ℃ (> 14 years old), axillary temperature < 37.5 ℃(≤14 years old);
- Female and male subjects of childbearing age agreed to take effective contraceptive measures during the study.
Who cannot join
- The results of physical examination and laboratory examination before screening were abnormal and clinically significant;
- Any component of the test vaccine, including aluminum preparation, has a history of severe allergy, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioneurotic edema, etc; Or the above-mentioned serious adverse reactions occurred after the use of any vaccine or drug in the past;
- Patients with history of SARS and SARS-CoV-2 (meet any of the following items):
- ① History of infection or history of SARS and SARS-CoV-2;
- ② During the epidemic of sras-cov-2, there was a history of contact with patients diagnosed / suspected with new crown;
- ③ The detection of SARS-CoV-2 IgM and / or IgG antibody was positive;
Show all 25Show fewer
- ④ RT-PCR was positive.
- They had taken antipyretics or analgesics within 24 hours before the first dose of vaccine;
- those who have been vaccinated with New Coronavirus or inoculated with live attenuated vaccine within 30 days within 14 days before the first dose of the vaccine are inoculated with the subunit vaccine and / or inactivated vaccine;
- Patients with the following diseases:
- ① Patients with acute (within 72 hours) febrile diseases (> 14 years old, axillary temperature ≥ 37.3 ℃; ≤4 years old,axillary temperature ≥37.5 ℃);
- ② Digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days;
- ③ Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc;
- ④ A history of congenital or acquired immunodeficiency or autoimmune disease or immunomodulatory therapy 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, local medication (such as ointment, eye drops, inhaler or nasal spray) is allowed;
- ⑤ Known to be diagnosed with infectious diseases, such as active tuberculosis, viral hepatitis, present or / or human immunodeficiency virus HIV antibody positive or syphilis specific antibody positive, or parents who are HIV infected;
- ⑥ Neurological diseases or neurodevelopmental disorders (e.g., migraine, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficit, Guillain Barre syndrome, encephalomyelitis or transverse myelitis); History of mental illness or family history;
- ⑦ Functional asplenia and splenectomy for any reason;
- ⑧ There are serious chronic diseases or disease in progress can not be controlled smoothly, such as diabetes, thyroid disease;
- ⑨ Severe liver and kidney diseases; Current respiratory diseases requiring daily medication (e.g., chronic obstructive pulmonary disease [COPD], asthma) or any treatment for exacerbation of respiratory diseases (e.g., asthma exacerbation) in the last five years; A history of severe cardiovascular disease (such as congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block,myocardial infarction, pulmonary heart disease), or myocarditis or pericarditis;
- ⑩ Thrombocytopenia, any coagulation dysfunction or anticoagulant therapy, etc;
- ⑪ Cancer patients.
- Received blood or blood related products, including immunoglobulin, within 3 months; or planned use during the study period;
- Have been pregnant (including positive urine pregnancy test), or in lactation;
- Use any research or unregistered product (drug, vaccine, biological product or device) other than the research product within 3 months, or plan to use it during the research period;
- Researchers believe that any disease or condition of the subject may put the subject at an unacceptable risk; The subjects could not meet the requirements of the protocol; Interference 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 Randomized, Blinded, Placebo-controlled Phase Ⅰ Clinical Trial of Recombinant New Coronavirus Vaccine (CHO Cells) in the Safety and Tolerability of Healthy People Aged 3 to 17 Years of Age
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (3~17 years old) Research purpose:Main purpose:To evaluate the safety and tolerability of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17. Secondary purpose: To explore the immunogenicity and persistence of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17.
Overall design:A single center, randomized, blind, placebo-controlled trial design was adopted.
Read more
Study population: 75 healthy people aged 3 to 17 years old, both male and female.
Test groups: 3 to 5 years old: 20 cases in experimental group and 5 cases in placebo group; 6 to 11 years old: 20 patients in the experimental group and 5 patients in the placebo group; 12 to 17 years old: 20 patients in experimental group and 5 patients in placebo group.
Read the detailed description
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (3~17 years old) .
Product name: Recombinant new coronavirus vaccine (CHO cell),Each dose contains 25μgNCP-RBD protein/0.5mL/bottle.
Indications: Prevention of respiratory diseases caused by new coronavirus infection .
Research population: healthy people aged 3 to 17 . Research Unit: Hunan Provincial Center for Disease Control and Prevention. Research purpose:Main purpose:To evaluate the safety and tolerability of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17. Secondary purpose: To explore the immunogenicity and persistence of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17.
Overall design:A single center, randomized, blind, placebo-controlled trial design was adopted.
Immunization program: 0, 1, and 2 months. Dose:25μg/0.5mL/bottle. Study population: 75 healthy people aged 3 to 17 years old, both male and female.
Test groups: 3 to 5 years old: 20 cases in experimental group and 5 cases in placebo group; 6 to 11 years old: 20 patients in the experimental group and 5 patients in the placebo group; 12 to 17 years old: 20 patients in experimental group and 5 patients in placebo group.
Research plan and implementation:According to the age from big to small, it was divided into three stages: 12 to 17 years old, 6 to 11 years old, 3 to 5 years old. The subjects of each age group were randomly divided into the experimental vaccine group and the placebo control group, 20 in the experimental vaccine group and 5 in the placebo group.
In the first stage, the subjects aged 12 to 17 years old were randomly divided into the experimental vaccine group (20 cases) and the placebo group (5 cases); The safety data of 0-7 days after the first dose were evaluated by the researchers. If the suspension / termination criteria were not met, the second phase of the study was carried out, and the subjects aged 6-11 years old in the trial vaccine group (20 cases) and placebo group (5 cases) were randomly enrolled; The safety data of subjects aged 6 to 17 years old from 0 to 7 days after the second dose of vaccine were evaluated by the researchers. If the suspension / termination criteria were not met, the third phase study was carried out, and the subjects aged 3 to 5 years old in the trial vaccine group (20 cases) and placebo group (5 cases) were randomly enrolled.
The subjects were followed up for 30 days after each dose. If the suspension / termination criteria were met, DSMB would decide whether to vaccinate the next dose; In other cases, it was up to the researchers to decide whether or not to receive the follow-up dose.
Safety endpoint:
- The incidence of all AEs within 1 month after the first dose to the full course of vaccination:
- Total AE incidence;
- The incidence of AEs related to research vaccines;
- The incidence of grade 3 and above AE;
- The incidence of grade 3 and above AEs related to research vaccines;
- The incidence of AEs leading to withdrawal;
- The incidence of AEs related to research vaccines leading to withdrawal; 2. The incidence of all serious adverse events (SAE) and the incidence of SAE related to the vaccine within 12 months after the first dose to the full course of vaccination; 3. Changes in the clinical significance of the laboratory test indicators after first and second dose of inoculation compared to before the first dose.
Immunogenicity endpoint:
Humoral immunity: before the first dose of vaccination, 1 month,3 month and 6 months after the full vaccination, neutralizing antibodies of novel coronavirus (SARS-CoV-2), S protein binding antibody (IgG), RBD protein binding antibody (IgG) ) Positive rate; The levels of neutralizing antibodies against SARS-CoV-2, S protein binding antibody (IgG) and RBD protein binding antibody (IgG) and their relative immunity 1 month , 3 month and 6 months after the full vaccination of all subjects increase the multiple before.
- Conditions
- Coronavirus
- Being tested
- Recombinant new coronavirus vaccine (CHO cell) group, Recombinant new coronavirus vaccine (CHO cells) placebo group
- Keywords
- Recombinant Novel Coronavirus Vaccine
- Medical subject headings
- Coronavirus Infections
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 armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).
Recombinant new coronavirus vaccine (CHO cells) placebo groupBiological
Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo.
| Study group | Role | What they receive |
|---|---|---|
| Population Ⅰ | Experimental | Population Ⅰ has 20 subjects aged 12 to 17 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. PopulationⅠis intramuscular injection of deltoid muscle of upper arm with vaccine. Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) group |
| Population Ⅱ | Placebo comparator | Population Ⅱ has 5 subjects aged 12 to 17 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅱ is a placebo intramuscular injection of deltoid muscle of the upper arm. Receives: Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group |
| Population Ⅲ | Experimental | Population Ⅲ has 20 subjects aged 6 to 11 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅲ is intramuscular injection of deltoid muscle of upper arm with vaccine. Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) group |
| Population Ⅳ | Placebo comparator | Population Ⅳ has 5 subjects aged 6 to 11 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅳ is a placebo intramuscular injection of deltoid muscle of the upper arm. Receives: Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group |
| Population Ⅴ | Experimental | Population Ⅴ has 20 subjects aged 3 to 5 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. PopulationⅤ is intramuscular injection of deltoid muscle of upper arm with vaccine. Receives: Biological: Recombinant new coronavirus vaccine (CHO cell) group |
| Population Ⅵ | Placebo comparator | Population Ⅵ has 5 subjects aged 3 to 5 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅵ is a placebo intramuscular injection of deltoid muscle of the upper arm. Receives: Biological: Recombinant new coronavirus vaccine (CHO cells) placebo 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 laboratory examination, local reactions and systemic reactions at the administration site.
Measured: 12 months after full vaccination
Immunogenic end point
The positive rate of neutralizing antibody, S protein binding antibody (IgG), RBD protein binding antibody (IgG) of all subjects before the first dose, 1 month，3 months and 6 months after the full vaccination. And titer levels and their fold increase before immunity.
Measured: Within 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 posted14 Jul 2021
- Study start3 Jul 2021
- Primary completion12 Dec 2021
- 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 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 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
- NCT04961359
- Sponsor's protocol ID
- LKM-2021-NCV01
- Status last verified
- Apr 2023
- First submitted
- 8 Jul 2021
- Last updated
- 25 Apr 2023
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Randomized, Blinded, Placebo-controlled Phase Ⅰ Clinical Trial of Recombinant New Coronavirus Vaccine (CHO Cells) in the Safety and Tolerability of Healthy People Aged 3 to 17 Years of Age
- ClinicalTrials.gov ID
- NCT04961359
- Acronym / sponsor ID
- LKM-2021-NCV01
- Conditions
- Coronavirus
- Keywords
- Recombinant Novel Coronavirus Vaccine
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 3 Jul 2021 (actual)
- Primary completion
- 12 Dec 2021 (actual)
- Study completion
- 6 Apr 2023 (actual)
- First posted
- 14 Jul 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: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (3~17 years old) Research purpose:Main purpose:To evaluate the safety and tolerability of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17. Secondary purpose: To explore the immunogenicity and persistence of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17.
Overall design:A single center, randomized, blind, placebo-controlled trial design was adopted.
Study population: 75 healthy people aged 3 to 17 years old, both male and female.
Test groups: 3 to 5 years old: 20 cases in experimental group and 5 cases in placebo group; 6 to 11 years old: 20 patients in the experimental group and 5 patients in the placebo group; 12 to 17 years old: 20 patients in experimental group and 5 patients in placebo group.
Detailed description
Popular topic: Phase I clinical trial of recombinant new coronavirus vaccine (CHO cell) (3~17 years old) .
Product name: Recombinant new coronavirus vaccine (CHO cell),Each dose contains 25μgNCP-RBD protein/0.5mL/bottle.
Indications: Prevention of respiratory diseases caused by new coronavirus infection .
Research population: healthy people aged 3 to 17 . Research Unit: Hunan Provincial Center for Disease Control and Prevention. Research purpose:Main purpose:To evaluate the safety and tolerability of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17. Secondary purpose: To explore the immunogenicity and persistence of recombinant New Coronavirus vaccine (CHO cells) in healthy people aged 3 to 17.
Overall design:A single center, randomized, blind, placebo-controlled trial design was adopted.
Immunization program: 0, 1, and 2 months. Dose:25μg/0.5mL/bottle. Study population: 75 healthy people aged 3 to 17 years old, both male and female.
Test groups: 3 to 5 years old: 20 cases in experimental group and 5 cases in placebo group; 6 to 11 years old: 20 patients in the experimental group and 5 patients in the placebo group; 12 to 17 years old: 20 patients in experimental group and 5 patients in placebo group.
Research plan and implementation:According to the age from big to small, it was divided into three stages: 12 to 17 years old, 6 to 11 years old, 3 to 5 years old. The subjects of each age group were randomly divided into the experimental vaccine group and the placebo control group, 20 in the experimental vaccine group and 5 in the placebo group.
In the first stage, the subjects aged 12 to 17 years old were randomly divided into the experimental vaccine group (20 cases) and the placebo group (5 cases); The safety data of 0-7 days after the first dose were evaluated by the researchers. If the suspension / termination criteria were not met, the second phase of the study was carried out, and the subjects aged 6-11 years old in the trial vaccine group (20 cases) and placebo group (5 cases) were randomly enrolled; The safety data of subjects aged 6 to 17 years old from 0 to 7 days after the second dose of vaccine were evaluated by the researchers. If the suspension / termination criteria were not met, the third phase study was carried out, and the subjects aged 3 to 5 years old in the trial vaccine group (20 cases) and placebo group (5 cases) were randomly enrolled.
The subjects were followed up for 30 days after each dose. If the suspension / termination criteria were met, DSMB would decide whether to vaccinate the next dose; In other cases, it was up to the researchers to decide whether or not to receive the follow-up dose.
Safety endpoint:
- The incidence of all AEs within 1 month after the first dose to the full course of vaccination:
- Total AE incidence;
- The incidence of AEs related to research vaccines;
- The incidence of grade 3 and above AE;
- The incidence of grade 3 and above AEs related to research vaccines;
- The incidence of AEs leading to withdrawal;
- The incidence of AEs related to research vaccines leading to withdrawal; 2. The incidence of all serious adverse events (SAE) and the incidence of SAE related to the vaccine within 12 months after the first dose to the full course of vaccination; 3. Changes in the clinical significance of the laboratory test indicators after first and second dose of inoculation compared to before the first dose.
Immunogenicity endpoint:
Humoral immunity: before the first dose of vaccination, 1 month,3 month and 6 months after the full vaccination, neutralizing antibodies of novel coronavirus (SARS-CoV-2), S protein binding antibody (IgG), RBD protein binding antibody (IgG) ) Positive rate; The levels of neutralizing antibodies against SARS-CoV-2, S protein binding antibody (IgG) and RBD protein binding antibody (IgG) and their relative immunity 1 month , 3 month and 6 months after the full vaccination of all subjects increase the multiple before.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Population Ⅰ | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell) groupPopulation Ⅰ has 20 subjects aged 12 to 17 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. PopulationⅠis intramuscular injection of deltoid muscle of upper arm with vaccine. |
| Population Ⅱ | Placebo comparator | Biological: Recombinant new coronavirus vaccine (CHO cells) placebo groupPopulation Ⅱ has 5 subjects aged 12 to 17 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅱ is a placebo intramuscular injection of deltoid muscle of the upper arm. |
| Population Ⅲ | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell) groupPopulation Ⅲ has 20 subjects aged 6 to 11 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅲ is intramuscular injection of deltoid muscle of upper arm with vaccine. |
| Population Ⅳ | Placebo comparator | Biological: Recombinant new coronavirus vaccine (CHO cells) placebo groupPopulation Ⅳ has 5 subjects aged 6 to 11 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅳ is a placebo intramuscular injection of deltoid muscle of the upper arm. |
| Population Ⅴ | Experimental | Biological: Recombinant new coronavirus vaccine (CHO cell) groupPopulation Ⅴ has 20 subjects aged 3 to 5 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. PopulationⅤ is intramuscular injection of deltoid muscle of upper arm with vaccine. |
| Population Ⅵ | Placebo comparator | Biological: Recombinant new coronavirus vaccine (CHO cells) placebo groupPopulation Ⅵ has 5 subjects aged 3 to 5 and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅵ is a placebo intramuscular injection of deltoid muscle of the upper arm. |
Who may qualify
- Ages
- 3 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- Aged 3-17 years old (all inclusive);
- The subject voluntarily agrees to participate in the study (or the legal guardian of the subject voluntarily agrees the child to participate in the study), and the guardian and the subject (8-17 years old) sign the informed consent form, and can provide valid identification; Understand and comply with test protocol requirements;
- The subject and / or the legal guardian of the subject have the ability to understand the (non illiterate) study procedure and participate in the planned follow-up;
- Axillary temperature < 37.3 ℃ (> 14 years old), axillary temperature < 37.5 ℃(≤14 years old);
- Female and male subjects of childbearing age agreed to take effective contraceptive measures during the study.
Key exclusion criteria (25 listed)
- The results of physical examination and laboratory examination before screening were abnormal and clinically significant;
- Any component of the test vaccine, including aluminum preparation, has a history of severe allergy, such as anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis reaction (Arthus reaction), dyspnea, angioneurotic edema, etc; Or the above-mentioned serious adverse reactions occurred after the use of any vaccine or drug in the past;
- Patients with history of SARS and SARS-CoV-2 (meet any of the following items):
- ① History of infection or history of SARS and SARS-CoV-2;
- ② During the epidemic of sras-cov-2, there was a history of contact with patients diagnosed / suspected with new crown;
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 armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells). | Biological | Population Ⅰ, Population Ⅲ, Population Ⅴ |
| Recombinant new coronavirus vaccine (CHO cells) placebo groupIntramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo. | Biological | Population Ⅱ, Population Ⅳ, Population Ⅵ |
Primary outcome
The number of adverse events after intramuscular injection
Time frame: 12 months after full vaccination
The main observation methods of adverse reactions mainly include laboratory examination, local reactions and systemic reactions at the administration site.
Immunogenic end point
Time frame: Within 6 months after the last dose of vaccination
The positive rate of neutralizing antibody, S protein binding antibody (IgG), RBD protein binding antibody (IgG) of all subjects before the first dose, 1 month，3 months and 6 months after the full vaccination. And titer levels and their fold increase before immunity.
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.
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 Phase 1 study testing Recombinant new coronavirus vaccine (CHO cell) group 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 5 inclusion and 25 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. Some participants in this study may receive a placebo. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The number of adverse events after intramuscular injection (time frame: 12 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?
On the ClinicalTrials.gov record for NCT04961359, 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.