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
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.

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 .

Unknown status
Coronavirus

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).

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).

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).

Eligibility 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.

Eligibility Gender
All
Eligibility Age
Minimum: 18 Years ~ Maximum: 59 Years
Countries
China
Locations

Hunan Provincial Center for Disease Control and Prevention
Hunan, Changsha, China

Anhui Zhifei Longcom Biologic Pharmacy Co., Ltd.
NCT Number
Keywords
NOVID-19
MeSH Terms
Coronavirus Infections
Vaccines