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Recombinant New Coronavirus Vaccine (CHO Cells) to Prevent SARS-CoV-2 Phase I Clinical Trial (≥60 Years Old)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04550351
Recruitment Status : Recruiting
First Posted : September 16, 2020
Last Update Posted : September 16, 2020
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) (≥60 years old) Research purpose: Main purpose: To evaluate the safety and tolerability of different doses of recombinant new coronavirus vaccine (CHO cells) in healthy people aged 60 years and above. Secondary purpose: to initially explore the immunogenicity and durability of different doses of recombinant new coronavirus vaccine (CHO cells).

Overall design: A single-center, randomized, double-blind, placebo-controlled trial design was adopted.

Study population: a healthy population of 60 years and above, a total of 50 cases, both men and women.

Test groups: 20 cases in the low-dose group, 5 cases in the placebo group; 20 cases in the high-dose group, 5 cases in the placebo group.


Condition or disease Intervention/treatment Phase
Coronavirus Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cell) low-dose group Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) high-dose group Biological: Biological/Vaccine: Recombinant new coronavirus vaccine (CHO cells) placebo group Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 50 participants
Allocation: Randomized
Intervention Model: Sequential Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: A Randomized, Double-blind, Placebo-controlled Phase I Clinical Trial to Evaluate the Safety and Tolerability of Recombinant New Coronavirus Vaccines (CHO Cells) in Healthy People Aged 60 Years and Above
Actual Study Start Date : August 19, 2020
Estimated Primary Completion Date : October 31, 2021
Estimated Study Completion Date : December 31, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Population I
Population I has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population I is intramuscular injection of deltoid muscle of upper arm with low dose of vaccine.
Biological: Biological/Vaccine: 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
Population II has 20 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population II is a high-dose vaccine intramuscular injection of deltoid muscle of the upper arm.
Biological: Biological/Vaccine: 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
Population Ⅲ has 10 subjects and is considered negative for SARS-COV-2 and fluorescent RT-PCR nucleic acids. Population Ⅲ is a placebo intramuscular injection of deltoid muscle of the upper arm.
Biological: Biological/Vaccine: 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. 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 and 6 months after the full vaccination And titer levels and their fold increase before immunity.



Information from the National Library of Medicine

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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

standard constrain:

  1. Persons with full capacity for civil conduct aged ≥60 years;
  2. Subjects voluntarily agree to participate in the research and sign an informed consent form, and can provide valid identification; understand and comply with the requirements of the trial protocol; have the ability to understand (non-illiterate) research procedures and participate in the planned follow-up;
  3. Axillary body temperature <37.3℃;
  4. Female subjects and male subjects of childbearing age agree to take effective contraceptive measures during the study period.

Exclusion criteria:

  1. The results of physical examination and laboratory examination before screening are abnormal and clinically significant as judged by clinicians, or systolic blood pressure ≥160mmHg and/or diastolic blood pressure ≥100mmHg before screening;
  2. 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, blood vessels Neuroedema, etc.; or any previous history of serious side effects after the use of any vaccine or drug;
  3. People with a history of SARS and SARS-CoV-2 (meet any of the following: ①Have a history of SARS and SARS-CoV-2 infection or onset; ②During this SRAS-CoV-2 epidemic, there are patients who have been diagnosed with the new crown/ Suspected patient contact history);
  4. Have taken antipyretic or analgesic within 24 hours before the first dose of vaccination;
  5. Inoculate subunit vaccine and/or inactivated vaccine within 14 days before the first dose of vaccine, and inoculate live attenuated vaccine within 30 days;
  6. People suffering from the following diseases:

    • Acute (within 72 hours) feverish illness;

      • Suffering from digestive system diseases (such as diarrhea, abdominal pain, vomiting, etc.) in the past 7 days;

        • Suffering from congenital malformations or developmental disorders, genetic defects, severe malnutrition, etc.;

          • Congenital or acquired immunodeficiency or autoimmune disease history or receiving immunomodulator treatment within 6 months, such as hormones; or monoclonal antibodies; or thymosin; or interferon, etc.; but local medication (such as ointment, Eye drops, inhalation or nasal spray);

            • Known to have been diagnosed with infectious diseases, such as: tuberculosis, viral hepatitis and/or human immunodeficiency virus HIV antibody positive or syphilis specific antibody positive;

              • Neurological diseases or neurodevelopmental dysfunction (for example, migraine, epilepsy, stroke, seizures in the last three years, encephalopathy, focal neurological deficits, Guillain-Barré syndrome, encephalomyelitis or transverse myelitis; History of mental illness or family history;

                ⑦Functional asplenia, as well as any cause of aspleen or splenectomy;

                ⑧Severe chronic diseases or conditions that cannot be controlled smoothly in the advanced stage, such as diabetes and thyroid disease;

                ⑨Severe liver and kidney diseases; respiratory diseases that currently require daily drug treatment (for example, chronic obstructive pulmonary disease [COPD], asthma) or any treatment for exacerbation of respiratory diseases (for example, asthma exacerbation) in the last 5 years; suffering from severe History of cardiovascular disease (such as congestive heart failure, cardiomyopathy, ischemic heart disease, arrhythmia, conduction block, myocardial infarction, pulmonary heart disease) or myocarditis or pericarditis;

                ⑩Have thrombocytopenia, any coagulation dysfunction or receive anticoagulant treatment, etc.;

                ?Tumor patients;

  7. Have received blood or blood-related products, including immunoglobulin, within 3 months; or plan to use it during the research period;
  8. Those who are already pregnant (including a positive urine pregnancy test), or are breastfeeding;
  9. Any research or unregistered products (drugs, vaccines, biological products or devices) other than research products have been used within 3 months, or planned to be used during the research period;
  10. The investigator believes that any disease or condition in the subject may put the subject at an unacceptable risk; the subject cannot meet the requirements of the protocol; it interferes with the assessment of the 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): NCT04550351


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

Locations
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China, Changsha
Hunan Provincial Center for Disease Control and Prevention Recruiting
Xiangtan, Changsha, 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: NCT04550351    
Other Study ID Numbers: LKM-2020-NCV03
First Posted: September 16, 2020    Key Record Dates
Last Update Posted: September 16, 2020
Last Verified: August 2020
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