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Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2(COVID-19) Phase I Clinical Trial (3~17 Years Old)

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ClinicalTrials.gov Identifier: NCT04961359
Recruitment Status : Recruiting
First Posted : July 14, 2021
Last Update Posted : July 23, 2021
Sponsor:
Information provided by (Responsible Party):
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Brief 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. 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.


Condition or disease Intervention/treatment Phase
Coronavirus Biological: Recombinant new coronavirus vaccine (CHO cell) group Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 75 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : July 3, 2021
Estimated Primary Completion Date : November 2021
Estimated Study Completion Date : December 2022

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Population Ⅰ
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.
Biological: Recombinant new coronavirus vaccine (CHO cell) group
Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Placebo Comparator: Population Ⅱ
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.
Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group
Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo.

Experimental: Population Ⅲ
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.
Biological: Recombinant new coronavirus vaccine (CHO cell) group
Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Placebo Comparator: Population Ⅳ
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.
Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group
Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo.

Experimental: Population Ⅴ
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.
Biological: Recombinant new coronavirus vaccine (CHO cell) group
Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Placebo Comparator: Population Ⅵ
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.
Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group
Intramuscular injection of deltoid muscle of upper armof 0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells) placebo.




Primary Outcome Measures :
  1. 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.

  2. 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.



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Ages Eligible for Study:   3 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  1. Aged 3-17 years old (all inclusive);
  2. 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;
  3. 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;
  4. Axillary temperature < 37.3 ℃ (> 14 years old), axillary temperature < 37.5 ℃(≤14 years old);
  5. Female and male subjects of childbearing age agreed to take effective contraceptive measures during the study.

Exclusion Criteria:

  1. The results of physical examination and laboratory examination before screening were abnormal and clinically significant;
  2. 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;
  3. 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;

    ④ RT-PCR was positive.

  4. They had taken antipyretics or analgesics within 24 hours before the first dose of vaccine;
  5. 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;
  6. 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.

  7. Received blood or blood related products, including immunoglobulin, within 3 months; or planned use during the study period;
  8. Have been pregnant (including positive urine pregnancy test), or in lactation;
  9. 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;
  10. 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04961359


Contacts
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Contact: Fangjun Li, Undergraduate 13574109585 646022285@qq.com

Locations
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China, Hunan
Hunan Provincial Center for Disease Control and Prevention Recruiting
Changsha, Hunan, China, 411228
Contact: Fangjun Li    13574109585    646022285@qq.com   
Sponsors and Collaborators
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
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Responsible Party: Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
ClinicalTrials.gov Identifier: NCT04961359    
Other Study ID Numbers: LKM-2021-NCV01
First Posted: July 14, 2021    Key Record Dates
Last Update Posted: July 23, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.:
Recombinant Novel Coronavirus Vaccine
Additional relevant MeSH terms:
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Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Virus Diseases
Vaccines
Immunologic Factors
Physiological Effects of Drugs