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

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.2 sites in 1 country450 target enrollmentJune 28, 2022

ConditionsSARS-CoV-2 Infection

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: SARS-CoV-2 Infection
Sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Enrollment: 450
Locations: 2
Primary Endpoint: Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody
Status: Active, Not Recruiting
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief 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.

Registry

clinicaltrials.gov

Start Date

June 28, 2022

End Date

June 28, 2023

Last Updated

2 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age at the time of the first dose of vaccine: 18 and above;
•Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment;
•Based on the medical history, physical examination and laboratory examination results, the investigator clinically determined the qualified person.
•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:
•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;
•Positive for SARS-CoV-2 antibody test;
•History of allergy to paracetamol or vaccination (such as acute allergic reaction, urticaria, dyspnea, angioedema, or abdominal pain);
•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;
•Has a medical or family history of epilepsy or convulsion, neurological disorders, mental disorders, etc.;
•Is contraindications for intramuscular injection, such as diagnosed thrombocytopenia, any coagulation disorder or receiving anticoagulant treatment, etc.;
•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);
•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;
•Has known immunological impairment or immunodeficiency diagnosed by hospital before enrollment, or functional asplenia or splenectomy caused by any condition;

Outcomes

Primary Outcomes

Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody

Time Frame: 14 days after the second dose

Adverse events (AEs), including solicited AEs and unsolicited AEs

Time Frame: From the first dose through 30 days following the second dose

AEs associated with the study intervention

Time Frame: From the first dose through 30 days following the second dose

Secondary Outcomes

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.)
Laboratory test related adverse events(4 days following each dose.)
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.)
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)