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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05439824
Recruitment Status : Recruiting
First Posted : June 30, 2022
Last Update Posted : July 7, 2022
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

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.

Condition or disease Intervention/treatment Phase
SARS-CoV-2 Infection Biological: SYS6006 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
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
Actual Study Start Date : June 28, 2022
Estimated Primary Completion Date : December 28, 2022
Estimated Study Completion Date : June 28, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Vaccines

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
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
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: SYS6006
SARS-CoV-2 mRNA Vaccine




Primary Outcome Measures :
  1. 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 ]
  2. Adverse events (AEs), including solicited AEs and unsolicited AEs [ Time Frame: From the first dose through 30 days following the second dose ]
  3. AEs associated with the study intervention [ Time Frame: From the first dose through 30 days following the second dose ]

Secondary Outcome Measures :
  1. Serious adverse events (SAEs) [ Time Frame: from the first dose through 12 months after the second dose. ]
  2. Adverse events of special interest (AESIs) [ Time Frame: rom the first dose through 12 months after the second dose. ]
  3. Laboratory test related adverse events [ Time Frame: 4 days following each dose. ]
  4. Geometric Mean Titer(GMT), Geometric Mean Fold Increase (GMI) and Seroconversion Rate (SCR) of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody [ Time Frame: from the first dose through 21 days ]
  5. GMT, GMI and SCR of serum anti-SARS-CoV-2 neutralizing antibody and IgG antibody [ Time Frame: 30, 90, 180 and 360 days after the second dose. ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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 medical history, physical examination and laboratory test results, the Investigator will clinically determine the physically qualified participants.
  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 stably controlled diabetes/hypertension) 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 plan to permanently relocate before the end of study; or plan to leave the resident location for a long time at the scheduled visit; or has any other conditions that are inappropriate for participation for this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05439824


Contacts
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Contact: Yuanzheng Qiu 13691347382 qiuyuanzheng@mail.ecspc.com

Locations
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China, Hebei
Hebei Provincial Center For Disease Control and Prevention Recruiting
Shijia Zhuang, Hebei, China, 050024
Contact: Yuliang Zhao    86 0311 86573395    yuliang_zh@163.com   
Principal Investigator: Yuliang Zhao         
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Principal Investigator: Yuliang Zhao Center For Disease Control and Prevention, Hebei Province
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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT05439824    
Other Study ID Numbers: SYS6006-003
First Posted: June 30, 2022    Key Record Dates
Last Update Posted: July 7, 2022
Last Verified: June 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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COVID-19
Respiratory Tract Infections
Infections
Pneumonia, Viral
Pneumonia
Virus Diseases
Coronavirus Infections
Coronaviridae Infections
Nidovirales Infections
RNA Virus Infections
Lung Diseases
Respiratory Tract Diseases