A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 18 -59 Years.
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ClinicalTrials.gov Identifier: NCT05354089 |
Recruitment Status :
Enrolling by invitation
First Posted : April 29, 2022
Last Update Posted : December 21, 2022
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Condition or disease | Intervention/treatment | Phase |
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SARS-CoV-2 | Biological: 20 μg dose of SYS6006;30 μg dose of SYS6006 Drug: Placebo | Phase 1 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 40 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Prevention |
Official Title: | A Phase I, Randomized, Observer-blinded, Placebo-controlled and Dose-escalation Clinical Trial to Evaluate the Safety and Preliminary Immunogenicity of a SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 18 -59 Years. |
Actual Study Start Date : | April 27, 2022 |
Actual Primary Completion Date : | July 9, 2022 |
Estimated Study Completion Date : | October 1, 2023 |
Arm | Intervention/treatment |
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Experimental: Vaccine group
20 μg dose of SYS6006 vaccine IM, on day 0 and day 21. 30 μg dose of SYS6006 vaccine IM, on day 0 and day 21.
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Biological: 20 μg dose of SYS6006;30 μg dose of SYS6006
20 μg dose of SYS6006 vaccine IM on day 0 and day 21. 30 μg dose of SYS6006 vaccine IM on day 0 and day 21. |
Placebo Comparator: Placebo
Placebo IM, on day 0 and day 21.
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Drug: Placebo
Placebo IM on day 0 and day 21. |
- Adverse events, including solicited and unsolicited events [ Time Frame: From the first dose through 30 days following the second dose. ]
- adverse events associated with the study intervention [ Time Frame: From the first dose through 30 days following the second dose. ]
- Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of anti-SARS-CoV-2 antibody (specific IgG antibody and neutralizing antibody) [ Time Frame: 14 days after the first dose; 7 days, 14 days, 30 days, 90 days, 180 days and 360 days after the second dose ]
- Serious adverse events (SAE) [ Time Frame: from the first dose through 12 months after the second dose. ]
- Adverse events of special interest (AESI) [ Time Frame: from the first dose through 12 months after the second dose. ]
- Laboratory test related adverse events [ Time Frame: 4 days following each dose ]

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Ages Eligible for Study: | 18 Years to 59 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Age at the time of the first dose of vaccine: 18 to 59 years;
- Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment;
- 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;
- Has independent judgment, and participate voluntarily and sign an informed consent form.
Exclusion Criteria:
- 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;
- Positive SARS-CoV-2 antibody test;
- Previous history of allergy to acetaminophen or vaccination(eg, acute allergic reaction, urticaria, dyspnea, angioneurotic edema, or abdominal pain);
- Has a history of COVID-19 vaccination, or have received other inactivated or recombinant vaccines within 7 days, or received live attenuated vaccines within 14 days,before the first dose;
- Has a medical history or family history of epilepsy, convulsions, neurological diseases and psychiatric diseases;
- Is contraindicative for intramuscular injection,such as: diagnosed thrombocytopenia, any coagulation disorders, or receiving anticoagulant therapy;
- 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);
- Has chronic diseases (such as Down syndrome, sickle cell anemia, neurological disorders and Guillain-Barre syndrome, excluding stably controlled diabetes/hypertension) that are not suitable for this study at the discretion of the Investigator;
- Has known immunocompromised conditions diagnosed in hospital before enrollment, or functional aspleen or splenectomy caused by any condition;
- For women of childbearing potential: positive pregnancy test, being in pregnancy or breastfeeding, or have a pregnancy plan within one year;men: whose spouses is of childbearing potential and has a pregnancy plan within 1 year;
- Is participating in other clinical trials or plan to participate in other clinical trials during the study period;
- 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;
- 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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05354089
China, Jiangsu | |
Sir Run Run Hosipital Nanjing Medical University | |
Nanjing, Jiangsu, China | |
China, Zhejiang | |
Shulan(hangzhou) Hospital | |
Hangzhou, Zhejiang, China |
Principal Investigator: | Lanjuan Li | Shulan (Hangzhou) Hospital | |
Principal Investigator: | Guiling Chen | Shulan (Hangzhou) Hospital | |
Principal Investigator: | Xiang Lu | Sir Run Run Hosipital Nanjing Medical University | |
Principal Investigator: | Yuwen Su | Sir Run Run Hosipital Nanjing Medical University |
Responsible Party: | CSPC ZhongQi Pharmaceutical Technology Co., Ltd. |
ClinicalTrials.gov Identifier: | NCT05354089 |
Other Study ID Numbers: |
SYS6006-001 |
First Posted: | April 29, 2022 Key Record Dates |
Last Update Posted: | December 21, 2022 |
Last Verified: | June 2022 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |