Status:
UNKNOWN
Clinical Study of Recombinant Novel Coronavirus Vaccine
Lead Sponsor:
Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
Conditions:
Coronavirus
Eligibility:
All Genders
18-59 years
Phase:
PHASE2
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 lo...
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 lo...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
July 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 15 2021
Estimated Enrollment :
900 Patients enrolled
Trial Details
Trial ID
NCT04466085
Start Date
July 12 2020
End Date
December 15 2021
Last Update
December 3 2020
Active Locations (1)
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1
Hunan Provincial Center for Disease Control and Prevention
Hunan, Changsha, China