Novel Coronavirus Pneumonia (COVID-19)
Conditions
Interventions
Low dose group:Low dose vaccine
Median dose group:Medium dose vaccine
Control group:Normal saline
Sponsors
Chengdu Xinhua Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 59 Years
Inclusion criteria
Inclusion criteria: 1. Aged >= 18 years, body mass index (BMI) in the range of 18 to 30 (including the threshold), can provide legal identification. 2. The subjects voluntarily agreed to participate in the study and signed the informed consent. 3. Subject has the ability to understand study procedures and is willing and able to comply with all study plan contents and other study requirements. 4. Body temperature <=37.3? (armpit body temperature) on the day of enrollment. 5. Throat swabs tested by RT-PCR were negative for SARS-CoV-2 and negative for SARS-CoV-2 antibodies, and there was no history of SARS, SARS-CoV-2 or MERS infection. 6. (Consultation) Female non-pregnancy (pregnancy test results are negative), non-lactation period. 7. (Consultation) Female subjects of childbearing age had taken effective contraceptive measures 1 month before enrollment. 8. (Consultation) Female subjects and male subjects of childbearing age agree to take effective contraceptive measures within 12 months from screening visit to full vaccination. 9. (Consultation) Female subjects of reproductive age and male subjects agree not to donate eggs (oocytes, oocytes) for assisted reproduction (female subjects of reproductive age) or sperm donation (male subjects) for 12 months from screening visit to full vaccination.
Exclusion criteria
Exclusion criteria: 1. Before participating in this study, the most recent vital signs or laboratory indicators (such as tests) are clinically significant as determined by the investigators; 2. (Consults) A history of severe allergy (including drugs, vaccines, and foods) or to any component of the experimental vaccine, for example: anaphylaxis, allergic laryngeal edema, Henoch–Sch?nlein purpura, Thrombocytopenic purpura, dyspnea, angioedema, etc.; 3. (Consults) Subjects Have been diagnosed with a serious disease, congenital malformation or chronic disease (including but not limited to: respiratory disease or bronchitis such as asthma, serious cardiovascular disease, kidney disease, autoimmune disease, thalassemia, malignant tumor, hereditary allergic constitution, etc.) that may interfere with the conduct or completion of the study; 4. (Consults) Diagnosed with a congenital or acquired immune deficiency or suppression, or suspected of having a systemic disease that may interfere with the conduct or completion of the study, for example: tuberculosis, Hepatitis B, hepatitis C, human immunodeficiency virus (HIV) , syphilis infection, no spleen or spleen dysfunction; 5. (Consults) Have lymph node-related diseases (such as lymphadenitis, lymph node adhesion, lymph node tuberculosis, tumor metastasis, etc.) or lymph node skin scar, fistula, and be found lymphadenopathy, tenderness, lymph node site skin redness and so on within 7 days before the inoculation; 6. (Consults) History of convulsion, epilepsy, encephalopathy or mental illness or family history. History of narcolepsy; 7. (Consults) Within 3 days prior to vaccination, an acute illness or attack of a chronic disease, or the use of antipyretic analgesic or antiallergic drugs; 8. (Consults) There are contraindications to intramuscular injection, such as having been diagnosed with thrombocytopenia, any blood clotting disorder, or receiving anticoagulant therapy; 9. (Consults) Long-term use of immunopotentiator or immunosuppressant therapy within 6 months prior to vaccination (continuous oral or injection for more than 14 days); 10.(Consults) Use of any blood or blood-related products (e.g. blood transfusion, use of human albumin, human immunoglobulin, etc.) within 6 months prior to vaccination; 11.(Consults) Any blood loss of more than 400 mL (e.g. donated blood or component blood or injury) during the 28 days prior to the screening period. Or planned blood or component blood donation between the screening period and 28 days after the vaccination; 12.(Consults) Other SARS-CoV-2 vaccines have been administered; 13.(Consults) Other vaccines have been administered within 4 weeks prior to the trial vaccination or other vaccination schedule (except for emergency vaccinations such as Rabies vaccine and Tetanus vaccine) between the screening period and 28 days after the vaccination; 14.(Physical examination) Any abnormal or permanent body art (such as tattoos) at the site of the vaccination, which the researchers think to interfere with observing local reactions at the site of the vaccination; 15.(Consults) Between the screening period and 12 months after vaccination, the female subjects have a pregnancy plan or the male subjects have a pregnancy plan; 16.(Consults) Participating in or planning to participate in other clinical trials (drugs or vaccines) within 3 months prior to participating in this study; 17.The researchers conclude that the subjects have any condition that might interfere
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Neutralizing antibody; | — |
Secondary
| Measure | Time frame |
|---|---|
| Specific IgG antibody;Incidence of grade >=3 adverse events;Incidence of serious adverse events; | — |
Countries
China
Contacts
Public ContactOu Yangzi
Argorna Pharmaceuticals Co., Ltd.
Outcome results
None listed