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

• ClinicalTrials.gov Identifier: NCT05354089
• Recruitment Status: Enrolling by invitation
• First Posted: April 29, 2022
• Last Update Posted: December 21, 2022
• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Information provided by (Responsible Party): CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Tracking Information

• First Submitted Date: April 28, 2022
• First Posted Date: April 29, 2022
• Last Update Posted Date: December 21, 2022
• Actual Study Start Date: April 27, 2022
• Actual Primary Completion Date: July 9, 2022 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: December 20, 2022)

• 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. ]

Original Primary Outcome Measures (submitted: April 28, 2022)

• adverse 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. ]

Current Secondary Outcome Measures (submitted: April 28, 2022)

• 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 ]

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 18 -59 Years.
• 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.
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 1
• Study Design: Allocation: Randomized; Intervention Model: Parallel Assignment; Masking: Triple (Participant, Investigator, Outcomes Assessor); Primary Purpose: Prevention
• Condition: SARS-CoV-2

Intervention

• 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.
• Drug: Placebo
  Placebo IM on day 0 and day 21.

Study Arms

• 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.
  Intervention: Biological: 20 μg dose of SYS6006；30 μg dose of SYS6006
• Placebo Comparator: Placebo
  Placebo IM, on day 0 and day 21.
  Intervention: Drug: Placebo

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Enrolling by invitation
• Estimated Enrollment (submitted: December 20, 2022): 40
• Original Estimated Enrollment (submitted: April 28, 2022): 60
• Estimated Study Completion Date: October 1, 2023
• Actual Primary Completion Date: July 9, 2022 (Final data collection date for primary outcome measure)

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.

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years to 59 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: China

Administrative Information

• NCT Number: NCT05354089
• Other Study ID Numbers: SYS6006-001
• Has Data Monitoring Committee: Not Provided

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Original Responsible Party: Same as current
• Current Study Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• 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

• PRS Account: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Verification Date: June 2022