A Study of COVID-19 mRNA Vaccine (SYS6006) in Chinese Healthy Older Adults.
Study Details
Study Description
Brief Summary
This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalation clinical trial to evaluate the safety, tolerability and preliminary immunogenicity of COVID-19 mRNA Vaccine (SYS6006) in Chinese healthy adults aged 60 years and over.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 20 μg dose of SYS6006 20μg dose of SYS6006 vaccine IM, on day 0 and day 21. |
Biological: 20 μg dose of SYS6006
20 μg dose of SYS6006 vaccine IM on day 0 and day 21.
|
| Experimental: 30 μg dose of SYS6006 30 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.
|
| Placebo Comparator: Placebo placebo IM, on day 0 and day 21 . |
Drug: Placebo
Placebo IM on day 0 and day 21.
|
Outcome Measures
Primary Outcome Measures
- adverse events [From the first dose through 30 days following the second dose.]
- adverse events associated with the study intervention [From the first dose through 30 days following the second dose.]
Secondary Outcome Measures
- Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of anti-SARS-CoV-2 antibody (specific IgG antibody and neutralizing antibody ) [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) [from the first dose through 12 months after the second dose.]
- Adverse events of special interest (AESI) [from the first dose through 12 months after the second dose.]
- Laboratory test related adverse events [4 days following each dose.]
Eligibility Criteria
Criteria
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;
-
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;
-
Has known or suspected severe diseases by the judgement of investigators.
-
Has chronic diseases which at the discretion of investigator are inappropriate for participation;
-
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;
-
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.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Sir Run Run Hospital Nanjing Medical University | Nanjing | Jiangsu | China | |
| 2 | Shulan(hangzhou) Hospital | Hangzhou | Zhejiang | China |
Sponsors and Collaborators
- CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
- Principal Investigator: Lanjuan Li, Shulan Hospital of Hangzhou
- Principal Investigator: Guiling Chen, Shulan Hospital of Hangzhou
- Principal Investigator: Xiang Lu, Sir Run Run Hosipital Nanjing Medical University
- Principal Investigator: Yuwen Su, Sir Run Run Hosipital Nanjing Medical University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SYS6006-002