Safety and Immunogenicity of SYS6017 in Healthy Participants Aged 40 Years or More

Launched by CSPC MEGALITH BIOPHARMACEUTICAL CO.,LTD. · Apr 24, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at the safety and effectiveness of a new mRNA vaccine designed to help prevent herpes zoster, also known as shingles, in healthy adults aged 40 and older. Shingles is caused by a virus that can reactivate in the body after a previous chickenpox infection, and it can lead to painful rashes and other complications, especially in older adults. The study will involve healthy participants who meet specific criteria, such as being in good health and not having a history of shingles or related vaccines.

Participants in this trial can expect to receive either the investigational vaccine or a placebo (a harmless substance that looks like the vaccine but doesn’t contain any active ingredients) during the study. The trial is currently not recruiting participants, but when it begins, those who qualify will need to sign a consent form and attend scheduled visits to monitor their health. This study is important because it aims to improve vaccination options for preventing shingles, which can be particularly challenging for older adults.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Healthy participants aged 40 years or more;
• • 2. Be able to understand the study procedures and comply with the requirements of the protocol for the scheduled visits, voluntarily consent to participate in the study and sign the informed consent form (ICF);
• • 3. Being in good health at the discretion of investigators based on medical history inquiry, physical examination, laboratory test and electrocardiograph examination;
• • 4. For female participants of childbearing potential: no sexual activity or used effective contraceptive methods within one menstrual cycle before enrollment; no pregnancy plans and agree to used effective contraceptive methods with 8 months after enrollment.
• Exclusion Criteria:
• • 1. History of zoster;
• • 2. History of vaccination with varicella vaccine or zoster vaccine (including investigational vaccine);
• • 3. Axillary temperature ≥ 37.1℃ on the day of enrollment or within 24 h before enrollment;
• • 4. Have abnormal test or examination result that is of Grade 1 (inclusive) or more in accordance with the Guidelines for Adverse Event Grading Standards for Clinical Trials of Preventive Vaccines (2019) issued by China National Medical Products Administration or other applicable adverse event grading standards referred in the protocol;
• • 5. History of allergy to any component of the investigational vaccine, or history of severe allergic reaction (including but not limited to anaphylaxis, allergic laryngeal edema, Henoch-Schonlein purpura, thrombocytopenia purpura or Arthus reaction) to vaccines or medicines;
• • 6. History of myocarditis, pericarditis, or idiopathic cardiomyopathy, or any condition that would increase the risk of myocarditis or pericarditis;
• • 7. History of demyelinating diseases, including but not limited to Guillain-Barré syndrome, multiple sclerosis, ophthalmoneuromyelitis, acute disseminated encephalomyelitis, etc.
• • 8. Current epilepsy or convulsion, severe neurological or psychiatric disorders;
• • 9. Have contraindications to intramuscular injection, e.g., diagnosed thrombocytopenia, any coagulation disorders, or current treatment with anticoagulants, etc;
• • 10. Active malignant tumor, malignant tumor without adequate treatment, malignant tumor with a potential risk of recurrence during the study;
• • 11. Active, unstable, severe or uncontrolled cardiovascular and cerebrovascular diseases, thrombotic diseases, blood and lymphatic system diseases, liver and kidney diseases, respiratory diseases, metabolic diseases, musculoskeletal diseases, autoimmune diseases, etc;
• • 12. Have diagnosed immunocompromise or immunosuppression, congenital or functional asplenia, or splenectomy;
• • 13. Have received immunosuppressants, immunostimulants, or other immunomodulatory medicines (e.g., corticosteroids, ≥ 20 mg/d prednisone or equivalent) for a long time (defined as 14 days or more), within 6 months before enrollment, or planning to receive the aforementioned medicines during the study; inhaled and topical steroids are allowed;
• • 14. Have received whole blood, plasma, serum, immunoglobulins, or monoclonal antibodies within 3 months before enrollment, or planning to receive these products during the study;
• • 15. Blood donation or blood loss ≥ 450 mL within 1 month before enrollment, or planning to donate blood during the study;
• • 16. Have received any other vaccine within 30 days before enrollment, or planning to receive any other vaccine within 30 days after the last dose;
• • 17. Currently participating in or planning to participate in other clinical trials during the study;
• • 18. For female participant of childbearing potential: having positive urine pregnancy test, being in pregnancy or lactation before enrollment;
• • 19. Unable to comply with the study procedures or adhere to the study requirements, or there are other conditions that make the participation in this study inappropriate, as determined by the investigators.