Herpes zoster is caused by the reactivation of latent varicella-zoster virus (VZV) which stays in latency after its primary infection. Immunosenescence contributes significantly to elevating morbidity associated with aging. Vaccination plays a key role in reducing the disease burden of zoster and the associated complications. We are conducting a study entitled "A Randomized, Blinded, Placebo- and Active-Controlled, Adaptive Phase 2 Clinical Trial to Evaluate the Immunogenicity and Safety of SYS6017 (a Herpes Zoster mRNA Vaccine) in Healthy Participants Aged 40 Years and Above".
1. Individuals aged 40 years or older;
2. Able to understand the study procedures, comply with the protocol requirements to attend all the scheduled visits, voluntarily consent to participate in the study, and sign the informed consent form;
3. Is physically eligible at the discretion of investigators based on medical history inquiry and physical examination; For participants with chronic underlying diseases (e.g., diabetes mellitus, hypertension, hyperlipidemia and other chronic conditions), they may be enrolled if their conditions have been well controlled within 3 months prior to enrollment in this study (i.e., additional medical interventions or major adjustments to treatments are not required);
4. For female participants of childbearing potential: No sexual activity or effective contraceptive methods were used within one menstrual cycle before enrollment; No pregnancy plans and agree to adopt effective contraceptive methods within 8 months after enrollment.
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. History of allergy to any component of the investigational vaccine; or history of severe allergic reactions to vaccines or medications (including but not limited to anaphylaxis, allergic laryngeal edema, Henoch-Schönlein purpura, thrombocytopenic purpura, or Arthus reaction);
Parallel
A zoster mRNA vaccine SYS6017
Biological/VaccineSYS6017，two-dose vaccination schedule (Month 0, 2)
Placebo
Other intervention0.9% saline，two-dose vaccination schedule (Month 0, 2)
Active Comparator Vaccine
Biological/VaccineRecombinant Zoster Vaccine (CHO cell)，two-dose vaccination schedule (Month 0, 2)
7
Treatment groupsSee each treatment group below.
solicited adverse events
unsolicited adverse events
Geometric Mean Concentration (GMC) of anti-gE antibody
Geometric Mean Fold Increase (GMFI) of anti-gE antibody
serious adverse events
adverse events of special interest
pregnancy events reported by the participants
Geometric Mean Titer (GMT) of anti-VZV antibody
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This trial is not recruiting at the moment. You can still explore other options:
