Clinical trial NCT05439824: A Study of SARS-CoV-2 mRNA Vaccine (SYS6006) in Chinese Healthy Participants Aged 18 Years or More
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE2
Conditions: SARS-CoV-2 Infection
Lead sponsor: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 450
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody
timeFrame: 14 days after the second dose
measure: Adverse events (AEs), including solicited AEs and unsolicited AEs
timeFrame: From the first dose through 30 days following the second dose
measure: AEs associated with the study intervention
timeFrame: From the first dose through 30 days following the second dose
Secondary outcomes:
measure: Serious adverse events (SAEs)
timeFrame: from the first dose through 12 months after the second dose.
measure: Adverse events of special interest (AESIs)
timeFrame: rom the first dose through 12 months after the second dose.
measure: Laboratory test related adverse events
timeFrame: 4 days following each dose.
measure: Geometric Mean Titer(GMT), Geometric Mean Fold Increase (GMI) and Seroconversion Rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody
timeFrame: from the first dose through 21 days
measure: GMT, GMI and SCR of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody
timeFrame: 30, 90, 180 and 360 days after the second dose.
Other outcomes:
Locations:
city: Shijia Zhuang
country: China
facility: Hebei Provincial Center For Disease Control and Prevention
state: Hebei
city: Nanjing
country: China
facility: Sir Run Run Hosipital Nanjing Medical University
state: Jiangsu
Study officials:
affiliation: Center For Disease Control and Prevention, Hebei Province
name: Yuliang Zhao
role: PRINCIPAL_INVESTIGATOR
affiliation: Jiangsu Provincial Center for Disease Control and Prevention
name: Jingxin Li
role: PRINCIPAL_INVESTIGATOR
affiliation: Nanjing Medical University
name: Xiang Lu
role: PRINCIPAL_INVESTIGATOR
References: