This is a phase 2, randomized, observer-blinded, placebo-controlled clinical study toevaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (SYS6006)in healthyparticipants aged 18 or more.
Not Provided
Biological: SYS6006 20 μg
SARS-CoV-2 mRNA Vaccine
Biological: SYS6006 30 μg
SARS-CoV-2 mRNA Vaccine
Biological: Placebo
Placebo
Inclusion Criteria:
1. Age at the time of the first dose of vaccine: 18 and above;
2. Axillary body temperature is less than 37.3 degree centigrade on the day of
enrollment;
3. Based on the medical history, physical examination and laboratory examination
results, the investigator clinically determined the qualified person.
4. Has independent judgment, and participate voluntarily and sign an informed consent
form.
Exclusion Criteria:
- Those who meet any of the following criteria must be excluded from this study:
1. Has a history of SARS or SARS-CoV-2 infection, or close contact with SARS-CoV-2
infected person( nucleic acid test positive), or living abroad within 30 days
before screening;
2. Positive for SARS-CoV-2 antibody test;
3. History of allergy to paracetamol or vaccination (such as acute allergic
reaction, urticaria, dyspnea, angioedema, or abdominal pain);
4. Has a history of vaccination with SARS-CoV-2 vaccine, or vaccination with other
inactivated or recombinant vaccine within 7 days or received live attenuated
vaccine within 14 days before the first dose;
5. Has a medical or family history of epilepsy or convulsion, neurological
disorders, mental disorders, etc.;
6. Is contraindications for intramuscular injection, such as diagnosed
thrombocytopenia, any coagulation disorder or receiving anticoagulant
treatment, etc.;
7. Has known or suspected serious disorders judged by the Investigator, including
but not limited to respiratory disorders (pulmonary failure, etc.), liver and
kidney disorders, cardiovascular disorders (cardiac failure, severe
hypertension, etc.), malignant tumors, infections or allergic skin disorders,
HIV infection, or in the acute infection or chronic disease activity period
(within 3 days before vaccination);
8. Has chronic diseases (such as Down syndrome, sickle cell anemia, neurological
disorders and Guillain-Barre syndrome, excluding chronic diseases such as
controlled stable diabetes mellitus/hypertension/hyperlipidemia) that are not
suitable for this study at the discretion of the Investigator;
9. Has known immunological impairment or immunodeficiency diagnosed by hospital
before enrollment, or functional asplenia or splenectomy caused by any
condition;
10. For women of childbearing potential: positive pregnancy test before the
enrollment, being in pregnant, breastfeeding, or have a pregnancy plan within 1
year; men: whose spouses is of childbearing potential and has a pregnancy plan
within 1 year;
11. Is participating or plan to participate in other clinical studies during the
study;
12. Has received immune enhancement or immunosuppressive therapy within 3 months
(continuous oral or instillation for more than 14 days); or received treatment
with whole blood, plasma and immunoglobulin within 1 month;
13. Is unlikely to adhere to the study procedures or keep appointments at the
discretion of the investigators;or has other conditions that are not suitable
for participating in this clinical trial.
Hebei Provincial Center For Disease Control and Prevention
Shijia Zhuang, Hebei, China
Sir Run Run Hosipital Nanjing Medical University
Nanjing, Jiangsu, China