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A Study of COVID-19 mRNA Vaccine (SYS6006) in Chinese Healthy Older Adults.

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: NCT05354063
Recruitment Status : Recruiting
First Posted : April 29, 2022
Last Update Posted : June 9, 2022
Sponsor:
Information provided by (Responsible Party):
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.

Brief Summary:
This is a phase I, randomized, observer-blinded, placebo-controlled and dose-escalation clinical trial to evaluate the safety, tolerability and preliminary immunogenicity of COVID-19 mRNA Vaccine (SYS6006) in Chinese healthy adults aged 60 years and over.

Condition or disease Intervention/treatment Phase
COVID-19 Biological: 20 μg dose of SYS6006 Biological: 30 μg dose of SYS6006 Drug: Placebo Phase 1

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: A Phase I, Randomized, Observer-blinded, Placebo-controlled and Dose-escalation Clinical Trial to Evaluate the Safety, Tolerability and Preliminary Immunogenicity of COVID-19 mRNA Vaccine (SYS6006) in Chinese Healthy Adults Aged 60 Years and Over.
Estimated Study Start Date : June 26, 2022
Estimated Primary Completion Date : October 1, 2022
Estimated Study Completion Date : October 1, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: 20 μg dose of SYS6006
20μg dose of SYS6006 vaccine IM, on day 0 and day 21.
Biological: 20 μg dose of SYS6006
20 μg dose of SYS6006 vaccine IM on day 0 and day 21.

Experimental: 30 μg dose of SYS6006
30 μg dose of SYS6006 vaccine IM, on day 0 and day 21.
Biological: 30 μg dose of SYS6006
30 μg dose of SYS6006 vaccine IM on day 0 and day 21.

Placebo Comparator: Placebo
placebo IM, on day 0 and day 21 .
Drug: Placebo
Placebo IM on day 0 and day 21.




Primary Outcome Measures :
  1. adverse events [ Time Frame: From the first dose through 30 days following the second dose. ]
  2. adverse events associated with the study intervention [ Time Frame: From the first dose through 30 days following the second dose. ]

Secondary Outcome Measures :
  1. Geometric mean titer (GMT), geometric mean increase (GMI) and seroconversion rate (SCR) of anti-SARS-CoV-2 antibody (specific IgG antibody and neutralizing antibody ) [ Time Frame: 14 days after the first dose; 7 days, 14 days, 30 days, 90 days, 180 days and 360 days after the second dose ]
  2. Serious adverse events (SAE) [ Time Frame: from the first dose through 12 months after the second dose. ]
  3. Adverse events of special interest (AESI) [ Time Frame: from the first dose through 12 months after the second dose. ]
  4. Laboratory test related adverse events [ Time Frame: 4 days following each dose. ]


Information from the National Library of Medicine

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Ages Eligible for Study:   60 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 to 59 years;
  2. Axillary body temperature is less than 37.3 degree centigrade on the day of enrollment;
  3. Based on the medical history and relevant physical examination and laboratory examination results (normal or abnormal but no clinical significance), the investigator clinically determined that the patient was in good health;
  4. Has independent judgment, and participate voluntarily and sign an informed consent form.

Exclusion Criteria:

  1. Has a history of SARS-CoV or SARS-CoV-2 infection, or close contact with SARS-CoV-2 infected persons (nucleic acid test positive) or living abroad within 30 days before screening;
  2. Positive SARS-CoV-2 antibody test;
  3. Previous history of allergy to acetaminophen or vaccination;
  4. Has a history of COVID-19 vaccination, or have received other inactivated or recombinant vaccines within 7 days, or received live attenuated vaccines within 14 days,before the first dose;
  5. Has a medical history or family history of epilepsy, convulsions, neurological diseases and psychiatric diseases;
  6. Is contraindicative for intramuscular injection;
  7. Has known or suspected severe diseases by the judgement of investigators.
  8. Has chronic diseases which at the discretion of investigator are inappropriate for participation;
  9. Has known immunocompromised conditions diagnosed in hospital before enrollment, or functional aspleen or splenectomy caused by any condition;
  10. For women of childbearing potential: positive pregnancy test, being in pregnancy or breastfeeding, or have a pregnancy plan within one year;
  11. Is participating in other clinical trials or plan to participate in other clinical trials during the study period;
  12. Has received immune enhancement or immunosuppressive therapy within 3 months before the first dose of vaccine (continuous oral or instillation for more than 14 days); or received whole blood, plasma and immunoglobulin therapy within one 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): NCT05354063


Contacts
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Contact: Yuanzheng Qiu +86 13691347382 qiuyuanzheng@mail.ecspc.com

Locations
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China, Jiangsu
Sir Run Run Hospital Nanjing Medical University Recruiting
Nanjing, Jiangsu, China
Contact: Xiang Lu    025 87115857    luxiang66@njmu.edu.cn   
China, Zhejiang
Shulan(hangzhou) Hospital Recruiting
Hangzhou, Zhejiang, China
Contact: Guiling Chen    +86 571 56097873    chenguiling707@126.com   
Sponsors and Collaborators
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Investigators
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Principal Investigator: Lanjuan Li Shulan (Hangzhou) Hospital
Principal Investigator: Guiling Chen Shulan (Hangzhou) Hospital
Principal Investigator: Xiang Lu Sir Run Run Hosipital Nanjing Medical University
Principal Investigator: Yuwen Su Sir Run Run Hosipital Nanjing Medical University
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Responsible Party: CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
ClinicalTrials.gov Identifier: NCT05354063    
Other Study ID Numbers: SYS6006-002
First Posted: April 29, 2022    Key Record Dates
Last Update Posted: June 9, 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