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

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: SARS-CoV-2 Infection
• Intervention / Treatment: Biological: Placebo; Biological: SYS6006 20 μg; Biological: SYS6006 30 μg

• Study Type: Interventional
• Enrollment (Actual): 450
• Phase: Phase 2

Contacts and Locations

Study Locations

• China
  • Hebei
    • Shijia Zhuang, Hebei, China, 050024
      • Hebei Provincial Center for Disease Control and Prevention
  • Jiangsu
    • Nanjing, Jiangsu, China
      • Sir Run Run Hosipital Nanjing Medical University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 20 μg dose of SYS6006 (Aged 18~59 years or 60 years or more); 20μg dose of SYS6006 vaccine IM, on day 0 and day 21.	Biological: SYS6006 20 μg; SARS-CoV-2 mRNA Vaccine
Experimental: 30 μg dose of SYS6006 (Aged 18~59 years or 60 years or more); 30 μg dose of SYS6006 vaccine IM, on day 0 and day 21.	Biological: SYS6006 30 μg; SARS-CoV-2 mRNA Vaccine
Placebo Comparator: Placebo(Aged 18~59 years or 60 years or more); placebo IM, on day 0 and day 21 .	Biological: Placebo; Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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
Adverse events (AEs), including solicited AEs and unsolicited AEs	From the first dose through 30 days following the second dose
AEs associated with the study intervention	From the first dose through 30 days following the second dose

Secondary Outcome Measures

Outcome Measure	Time Frame
Laboratory test related adverse events	4 days following each dose.
Serious adverse events (SAEs)	from the first dose through 12 months after the second dose.
Adverse events of special interest (AESIs)	rom the first dose through 12 months after the second dose.
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
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.

Collaborators and Investigators

• Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
• Investigators: Principal Investigator: Yuliang Zhao, Center For Disease Control and Prevention, Hebei Province; Principal Investigator: Jingxin Li, Jiangsu Provincial Center for Disease Control and Prevention; Principal Investigator: Xiang Lu, Sir Run Run Hospital, Nanjing Medical University

Study record dates

Study Major Dates

• Study Start (Actual): June 28, 2022
• Primary Completion (Actual): January 12, 2023
• Study Completion (Anticipated): June 28, 2023

Study Registration Dates

• First Submitted: June 27, 2022
• First Submitted That Met QC Criteria: June 27, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): May 24, 2023
• Last Update Submitted That Met QC Criteria: May 23, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Pneumonia, Viral; Pneumonia; Lung Diseases; COVID-19
• Other Study ID Numbers: SYS6006-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No