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Clinical Study of Recombinant Novel Coronavirus Vaccine

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ClinicalTrials.gov Identifier: NCT04466085
Recruitment Status : Recruiting
First Posted : July 10, 2020
Last Update Posted : July 27, 2020
Sponsor:
Information provided by (Responsible Party):
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.

Brief Summary:
A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases.

Condition or disease Intervention/treatment Phase
Coronavirus Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose group Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose group Biological: Recombinant new coronavirus vaccine (CHO cells) placebo group Phase 2

Detailed Description:

A total of 900 subjects are planned to be randomly divided into 2 doses of low-dose experimental vaccine group, 2 doses of high-dose experimental vaccine group, 2 doses of placebo group, 3 doses of low-dose experimental vaccine group, 3 doses of high-dose experimental vaccine group and 3 doses of placebo group, the sample size of each group was 150 cases.

Subjects in the 2 dose group were injected with 2 doses of test vaccine or placebo in the upper arm deltoid muscle according to the 0,1 month immunization program, and subjects in the 3 dose group were injected with 3 doses of test vaccine or placebo in the upper arm deltoid muscle according to the 0, 1, 2 month immunization program .

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 900 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Randomized, Blinded, Placebo-controlled Trial to Evaluate the Immunogenicity and Safety of a Recombinant New Coronavirus Vaccine (CHO Cell) With Different Doses and Different Immunization Procedures in Healthy People Aged 18 to 59 Years
Actual Study Start Date : July 12, 2020
Estimated Primary Completion Date : September 15, 2021
Estimated Study Completion Date : December 15, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Population I
In population I, there were 150 subjects who injected with 2 doses of low-dose test vaccine into the deltoid muscle of the upper arm according to the 0 and 1 month immunization schedule.
Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose group
Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Experimental: Population II
In population II, there were 150 subjects who injected with 2 doses of high-dose test vaccine in the upper arm deltoid muscle according to the 0 and 1 month immunization schedule.
Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose group
Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Placebo Comparator: Population Ⅲ
In population Ⅲ, there were 150 subjects who injected with 2 doses of placebo in the upper arm deltoid muscle according to the 0 and 1 month immunization schedule.
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).

Experimental: Population Ⅳ
In population Ⅳ, there were 150 subjects who injected with 3 doses of low-dose test vaccine in the upper arm deltoid muscle according to the 0, 1, and 2 month immunization schedule.
Biological: Recombinant new coronavirus vaccine (CHO cell) low-dose group
Intramuscular injection of deltoid muscle of upper armof 25μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Experimental: Population Ⅴ
In population Ⅴ, there were 150 subjects who injected with 3 doses of high-dose test vaccine into the deltoid muscle of the upper arm according to the immunization schedule of 0, 1, and 2 months.
Biological: Recombinant new coronavirus vaccine (CHO cells) high-dose group
Intramuscular injection of deltoid muscle of upper armof 50μg/0.5ml/person doseRecombinant new coronavirus vaccine (CHO cells).

Placebo Comparator: Population Ⅵ
In Population Ⅵ, there were 150 subjects who injected with 3 doses of placebo into the deltoid muscle of the upper arm according to the immunization schedule of 0, 1, and 2 months.
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).




Primary Outcome Measures :
  1. Neutralizing antibody positive conversion rate [ Time Frame: 30 days after inoculation ]
    Neutralizing antibody positive conversion rate in the pre-immunization negative population 30 days after full vaccination


Secondary Outcome Measures :
  1. Neutralizing antibody GMT, positive rate [ Time Frame: 14 days after inoculation ]
    GMT and positive rate of neutralizing antibody 14 days after the first dose of pre-vaccination people

  2. Neutralizing antibody GMT, positive conversion rate/positive rate [ Time Frame: 14 days after inoculation ]
    GMT, positive conversion rate/positive rate of neutralizing antibodies 14 days after full vaccination in the pre-vaccination population

  3. Neutralizing antibody GMT [ Time Frame: 30 days after inoculation ]
    Neutralizing antibody GMT 30 days after vaccination in pre-negative people

  4. Neutralizing antibody GMT [ Time Frame: 6th and 12th month after inoculation ]
    Neutralizing antibody GMT in the 6th and 12th month after the entire vaccination

  5. Neutralizing antibody GMI, positive rate [ Time Frame: 6th and 12th month after inoculation ]
    Neutralizing antibody GMI and positive rate at the 6th and 12th month of the entire vaccination

  6. IL-2, IL-4, IL-5, IL-6 and IFN-γ levels [ Time Frame: 4th day and 12 months after inoculation ]
    Levels of IL-2, IL-4, IL-5, IL-6 and IFN-γ on the 4th day and 12 months after the entire vaccination

  7. Adverse events [ Time Frame: 30 days after inoculation ]
    Adverse events 30 days after the first dose of vaccine to the entire exemption

  8. Serious adverse event [ Time Frame: 12 months after inoculation ]
    Serious adverse events from day 0 after vaccination to 12 months after the entire immunization



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years to 59 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Persons with full civil capacity aged 18-59 years (both included);
  • The subjects themselves voluntarily agreed to participate in the study, and signed an informed consent form, and can provide valid identification; understand and comply with the requirements of the trial protocol;
  • Body temperature under armpit <37.3℃;
  • Female and male subjects of childbearing age agreed to take effective contraceptive measures during the study.

Exclusion Criteria:

  • The vital signs and physical examination results of the population specified in the plan have clinical significance as determined by the clinician;
  • A history of severe allergies to any component of the test vaccine, including aluminum preparations, such as: anaphylactic shock, allergic laryngeal edema, allergic purpura, thrombocytopenic purpura, local allergic necrosis (Arthus reaction), dyspnea, vascular neuropathy Edema, etc.; or any previous history of serious side effects after using any vaccine or drug;
  • Those with a history of SARS and SARS-CoV-2 (meet any of the following: ① previous history of SARS and SARS-CoV-2 infection or morbidity; ② during the current SARS-CoV-2 epidemic, there are patients diagnosed/suspected with the new crown Contact history);
  • Have taken antipyretics or painkillers within 24 hours before the first dose of vaccination;
  • Within 14 days before the first dose of vaccination, subunit vaccines, inactivated vaccines, and live attenuated vaccines within 30 days;
  • People with the following diseases: Acute febrile disease; Digestive diseases (eg, diarrhea, abdominal pain, vomiting, etc.) in the past 7 days; Congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.; Congenital or Acquired immunodeficiency or a history of autoimmune diseases or treatment with immunomodulators within 6 months, such as hormones; or monoclonal antibodies; or thymosin; or interferon, etc.; however, topical medications (such as ointment, eye drops, Inhalation or nasal spray); known to be diagnosed with infectious diseases, such as: patients with tuberculosis, viral hepatitis and/or human immunodeficiency virus HIV positive or syphilis specific antibody positive; neurological disease or Neurodevelopmental dysplasia (eg, migraine, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficit, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis); history of psychiatric illness or family History; functional spleenlessness, and spleenlessness or splenectomy for any reason; severe chronic disease or disease in progress that cannot be controlled smoothly, such as diabetes, thyroid disease; severe liver and kidney disease; respiratory tract that currently requires daily medication Diseases (eg, chronic obstructive pulmonary disease [COPD], asthma) or any treatment that exacerbates respiratory diseases (eg, asthma exacerbations) within the last 5 years; has severe cardiovascular disease (eg, congestive heart failure, cardiomyopathy, Ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease) or a history of myocarditis or pericarditis; with thrombocytopenia, any coagulopathy, or treatment with anticoagulants; tumor patients;
  • Have received blood or blood-related products, including immunoglobulin, within 3 months; or plan to use it during the study;
  • Women who are breastfeeding or pregnant (including a positive urine pregnancy test);
  • Have used any research or unregistered product (medicine, vaccine, biological product or device) other than the research product within 3 months, or plan to use it during the research;
  • The researchers believe that any disease or condition in the subject may put the subject at an unacceptable risk; the subject cannot meet the protocol requirements; and interfere 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): NCT04466085


Contacts
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Contact: fangjun Li, bachelor 13574109585 646022285@qq.com
Contact: fan Di, master 18119631130 dingfan@zhifeishengwu.com

Locations
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China, Changsha
Hunan Provincial Center for Disease Control and Prevention Recruiting
Hunan, Changsha, China
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: NCT04466085    
Other Study ID Numbers: NCV-Ⅱ-healthy
First Posted: July 10, 2020    Key Record Dates
Last Update Posted: July 27, 2020
Last Verified: July 2020

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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.:
NOVID-19
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