SARS-CoV-2(COVID-19)
Conditions
Interventions
Cohort1:mRNA vaccine or placebo control
Cohort2:mRNA vaccine or placebo control
Sponsors
Chengdu Xinhua Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 100 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)Negative SARS-CoV-2 reverse transcription-polymerase chain reaction (RT-PCR) test and antibody screening was performed before immunization. (4)Subject has the ability to understand study procedures and is willing and able to comply with all study plan contents and other study requirements. (5)Willing and able to comply with clinical trial protocol requirements and be able to complete a 12-month study follow-up. (6)Completion of basic/booster immunization with COVID-19 vaccine prior to enrollment or at least 6 months after infection with COVID-19. (7)(Consultation) Female subjects and male subjects of childbearing age agree to take effective contraceptive measures within 12 months from screening visit to full vaccination.Female subjects of childbearing age had taken effective contraceptive measures 1 month before enrollment. (8)Female subjects of childbearing age in the screening period (negative result of pregnancy test) or lactation period. (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) The subject has a history of SARS-CoV-2 infection within 6 months. (2) Vital signs or physical examination during the screening period were clinically significant as determined by the investigator. (3) Fever on the day of enrollment, body temperature =37.3? (armpit body temperature). (4)(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. (5) (consultation)Subjects have contraindications to intramuscular injection, such as those who have been diagnosed with thrombocytopenia, platelet dysfunction, hereditary bleeding tendency, coagulation dysfunction, or receiving anticoagulant therapy. (6)(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, serious cerebrovascular disease, kidney disease, serious or uncontrollable diabetes, autoimmune disease, thalassemia, malignant tumor, hereditary allergic constitution, etc.) that may interfere with the conduct or completion of the study. (7) (Consults) have been diagnosed with diseases affecting the function of the immune system, including malignant tumors (other than skin basal cell carcinoma), congenital or acquired immunodeficiency or suppression (e.g., tuberculosis, human immunodeficiency virus infection (HIV)), hepatitis B, hepatitis C, syphilis infection, uncontrolled autoimmune diseases, asthenia or abnormal spleen function, etc. (8)(Consults) History of convulsions, convulsions, epilepsy, encephalopathy, meningitis, psychosis, encephalitis, myelitis, Guillain-Barre syndrome and other central nervous system diseases or family history; Or have a history of narcolepsy. (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 3 months prior to vaccination or received any organ or bone marrow transplant. (11)(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. (12)(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. (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)(Consults) Participating in or planning to participate in other clinical trials (drugs or vaccines) within 3 months prior to participating in this study. (15)(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. (16)(Physical examination) Any abnormal or permanent bod
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Solicited (local and systemic) adverse events (14 days after inoculation);all adverse events related to inoculation (within 28 days after inoculation); | — |
Secondary
| Measure | Time frame |
|---|---|
| Unsolicited Adverse Events (within 28 days after inoculation);Serious Adverse Events (SAEs) (within 12 months after inoculation);laboratory abnormalities (on Day 3 after inoculation);Neutralization antibody; IgG antibody;Cellular immunity; | — |
Countries
China
Contacts
Public ContactYong Xiaolan
Chengdu Xinhua Hospital
Outcome results
None listed