A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 18 -59 Years.

NCT ID: NCT05354089

Last Updated: 2023-05-24

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-27
• Study Completion Date: 2023-10-01

Brief Summary

This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalation clinical trial to evaluate the safety, tolerability, immunogenicity and immune persistence of SYS6006 (SARS-CoV-2 mRNA Vaccine) in 18-59 year old healthy population.

Conditions

SARS-CoV-2

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: TRIPLE

Study Groups

Vaccine group 1

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

Group Type: EXPERIMENTAL

20 μg dose of SYS6006

Intervention Type: BIOLOGICAL

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

Vaccine group 2

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

Group Type: EXPERIMENTAL

30 μg dose of SYS6006

Intervention Type: BIOLOGICAL

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

Placebo

Placebo IM, on day 0 and day 21.

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo IM on day 0 and day 21.

Interventions

20 μg dose of SYS6006

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

Intervention Type: BIOLOGICAL

30 μg dose of SYS6006

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

Intervention Type: BIOLOGICAL

Placebo

Placebo IM on day 0 and day 21.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

1. Age at the time of the first dose of vaccine: 18 to 59 years;

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 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;

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

6. Is contraindicative for intramuscular injection，such as: diagnosed thrombocytopenia, any coagulation disorders, or receiving anticoagulant therapy;

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 stably controlled diabetes/hypertension) that are not suitable for this study at the discretion of the Investigator;

9. Has known immunocompromised conditions diagnosed in hospital before enrollment, or functional aspleen or splenectomy caused by any condition;

10. 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;

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 59 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lanjuan Li

Role: PRINCIPAL_INVESTIGATOR

Shulan (Hangzhou) Hospital

Guiling Chen

Role: PRINCIPAL_INVESTIGATOR

Shulan (Hangzhou) Hospital

Xiang Lu

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Hosipital Nanjing Medical University

Yuwen Su

Role: PRINCIPAL_INVESTIGATOR

Sir Run Run Hosipital Nanjing Medical University

Locations

Sir Run Run Hosipital Nanjing Medical University

Nanjing, Jiangsu, China

Shulan(hangzhou) Hospital

Hangzhou, Zhejiang, China

Countries

China

Other Identifiers

SYS6006-001

Identifier Type: -

Identifier Source: org_study_id