NCT05439824Active, not recruitingPhase 2
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 enrollmentStarted: June 28, 2022Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 2
- Status
- Active, not recruiting
- Sponsor
- 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
Study 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Prevention
- Masking
- Triple (Participant, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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;
- •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;
- •Is participating or plan to participate in other clinical studies during the study;
- •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;
- •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.
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)
Investigators
Study Sites (2)
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