Official Title
A Phase I, Randomized, Observer-blinded, Placebo-controlled and Dose-escalation Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 60 Years and Over.
Brief Summary

This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalationclinical trial to evaluate the safety and preliminary immunogenicity of SARS-CoV-2 mRNAVaccine (SYS6006) in Chinese healthy adults aged 60 years and over.

Detailed Description

Not Provided

Active, not recruiting
SARS-CoV-2

Biological: 20 μg dose of SYS6006

20 μg dose of SYS6006 vaccine IM on day 0 and day 21.

Biological: 30 μg dose of SYS6006

30 μg dose of SYS6006 vaccine IM on day 0 and day 21.

Drug: Placebo

Placebo IM on day 0 and day 21.

Eligibility Criteria

Inclusion Criteria:

1. Age 60 years or older;

2. Axillary body temperature is less than 37.3 degree centigrade on the day of
enrollment;

3. Based on the medical history and relevant physical examination and laboratory
examination results (normal or abnormal but no clinical significance), the
investigator clinically determined that the patient was in good health;

4. Has independent judgment, and participate voluntarily and sign an informed consent
form.

Exclusion Criteria:

1. Has a history of SARS-CoV or SARS-CoV-2 infection, or close contact with SARS-CoV-2
infected persons (nucleic acid test positive) or living abroad within 30 days before
screening;

2. Positive SARS-CoV-2 antibody test;

3. Previous history of allergy to acetaminophen or vaccination(eg, acute allergic
reaction, urticaria, dyspnea, angioneurotic edema, or abdominal pain);

4. Has a history of SARS-CoV-2 vaccination, or have received other inactivated or
recombinant vaccines within 7 days, or received live attenuated vaccines within 14
days,before the first dose;

5. Has a medical history or family history of epilepsy, convulsions, neurological
diseases and psychiatric diseases;

6. Is contraindicative for intramuscular injection, such as having been diagnosed with
thrombocytopenia, any coagulation disorder, or receiving anticoagulant therapy;

7. Has known or suspected severe diseases by the judgement of investigators, including
but not limited to: respiratory diseases (lung failure, etc.), liver and kidney
diseases, cardiovascular diseases (heart failure, severe hypertension, etc.),
malignant tumors, infections or allergic skin diseases, HIV infection, or during the
acute infection or chronic disease activity period (within 3 days before
vaccination).

8. Has chronic diseases which at the discretion of investigator are inappropriate for
participation(such as Down 's syndrome, sickle cell anemia or neurological
disorders, Guillain-Barre syndrome, etc., not including stable diabetes
mellitus/hypertension);

9. Known immunological impairment or dysfunction diagnosed by the hospital before
enrollment, or functional asplenia or splenectomy due to any condition;

10. For women of childbearing potential: positive pregnancy test, being in pregnancy or
breastfeeding, or have a pregnancy plan within one year;male: their spouse of
childbearing age has plans to become pregnant within 1 year;

11. Is participating in other clinical trials or plan to participate in other clinical
trials during the study period;

12. Has received immune enhancement or immunosuppressive therapy within 3 months before
the first dose of vaccine (continuous oral or instillation for more than 14 days);
or received whole blood, plasma and immunoglobulin therapy within one month;

13. Is unlikely to adhere to the study procedures or keep appointments at the discretion
of the investigators;or plan to permanently relocate before the end of study; or
plan to leave the resident location for a long time at the scheduled visit; or has
any other conditions that are inappropriate for participation for this study.

Eligibility Gender
All
Eligibility Age
Minimum: 60 Years ~ Maximum: N/A
Countries
China
Locations

Sir Run Run Hospital Nanjing Medical University
Nanjing, Jiangsu, China

Shulan(hangzhou) Hospital
Hangzhou, Zhejiang, China

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
NCT Number