Immunogenicity and Safety of SYS6017 in the Participants Aged 40 Years and Above

ConditionHerpes Zoster
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age40+
SponsorCSPC Megalith Biopharmaceutical Co.,Ltd.

About this trial

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".

Eligibility criteria

Qualifiers

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.

Disqualifiers

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);

Trial design

Treatments tested in this trial

  • A zoster mRNA vaccine SYS6017
  • Placebo
  • Active Comparator Vaccine

Treatment groups

800 Participants
are divided into 7 treatment groups

7

Treatment groups

See each treatment group below.

Locations

This trial has no locations