A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Participants Aged 18 Years or More

SARS-CoV-2 Infection Clinical Trial

Official title:

A Randomized, Observer-blinded, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Immunogenicity and Safety of a SARS-CoV-2 mRNA Vaccine (SYS6006) in Healthy Participants Aged 18 Years or More

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05439824
• Other study ID #: SYS6006-003
• Status: Active, not recruiting
• Phase: Phase 2
• Start date: June 28, 2022
• Est. completion date: June 28, 2023

Study information

• Verified date: May 2023
• Source: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is a phase 2, randomized, observer-blinded, placebo-controlled clinical study to evaluate the immunogenicity and safety of SARS-CoV-2 mRNA Vaccine (SYS6006）in healthy participants aged 18 or more.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 450
• Est. completion date: June 28, 2023
• Est. primary completion date: January 12, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Age at the time of the first dose of vaccine: 18 and above;

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

3. Based on the medical history, physical examination and laboratory examination results, the investigator clinically determined the qualified person.

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

Exclusion Criteria:

• Those who meet any of the following criteria must be excluded from this study:

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

2. Positive for SARS-CoV-2 antibody test;

3. History of allergy to paracetamol or vaccination (such as acute allergic reaction, urticaria, dyspnea, angioedema, or abdominal pain);

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

5. Has a medical or family history of epilepsy or convulsion, neurological disorders, mental disorders, etc.;

6. Is contraindications for intramuscular injection, such as diagnosed thrombocytopenia, any coagulation disorder or receiving anticoagulant treatment, etc.;

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 chronic diseases such as controlled stable diabetes mellitus/hypertension/hyperlipidemia) that are not suitable for this study at the discretion of the Investigator;

9. Has known immunological impairment or immunodeficiency diagnosed by hospital before enrollment, or functional asplenia or splenectomy caused by any condition;

10. For women of childbearing potential: positive pregnancy test before the enrollment, being in pregnant, breastfeeding, or have a pregnancy plan within 1 year; men: whose spouses is of childbearing potential and has a pregnancy plan within 1 year;

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

12. Has received immune enhancement or immunosuppressive therapy within 3 months (continuous oral or instillation for more than 14 days); or received treatment with whole blood, plasma and immunoglobulin within 1 month;

13. Is unlikely to adhere to the study procedures or keep appointments at the discretion of the investigators;or has other conditions that are not suitable for participating in this clinical trial.

Related Conditions & MeSH terms

• COVID-19
• SARS-CoV-2 Infection

Intervention

Biological:
• SYS6006 20 µg
SARS-CoV-2 mRNA Vaccine
• SYS6006 30 µg
SARS-CoV-2 mRNA Vaccine
• Placebo
Placebo

Locations

Country	Name	City	State
China	Sir Run Run Hosipital Nanjing Medical University	Nanjing	Jiangsu
China	Hebei Provincial Center For Disease Control and Prevention	Shijia Zhuang	Hebei

Sponsors (1)

Lead Sponsor	Collaborator
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody		14 days after the second dose
Primary	Adverse events (AEs), including solicited AEs and unsolicited AEs		From the first dose through 30 days following the second dose
Primary	AEs associated with the study intervention		From the first dose through 30 days following the second dose
Secondary	Serious adverse events (SAEs)		from the first dose through 12 months after the second dose.
Secondary	Adverse events of special interest (AESIs)		rom the first dose through 12 months after the second dose.
Secondary	Laboratory test related adverse events		4 days following each dose.
Secondary	Geometric Mean Titer(GMT), Geometric Mean Fold Increase (GMI) and Seroconversion Rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody		from the first dose through 21 days
Secondary	GMT, GMI and SCR of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody		30, 90, 180 and 360 days after the second dose.