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".
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
TRIPLE
Enrollment
800
SYS6017,two-dose vaccination schedule (Month 0, 2)
0.9% saline,two-dose vaccination schedule (Month 0, 2)
Recombinant Zoster Vaccine (CHO cell),two-dose vaccination schedule (Month 0, 2)
solicited adverse events
Time frame: within 14 days post each vaccination
unsolicited adverse events
Time frame: within 30 days post each vaccination
Geometric Mean Concentration (GMC) of anti-gE antibody
Time frame: On Day 14 and Day 30 after the completion of the full vaccination course
Geometric Mean Fold Increase (GMFI) of anti-gE antibody
Time frame: On Day 14 and Day 30 after the completion of the full vaccination course
Seroconversion Rate (SCR) of anti-gE antibody
Time frame: On Day 14 and Day 30 after the completion of the full vaccination course
serious adverse events
Time frame: from the first vaccination through 12 months post the second vaccination
adverse events of special interest
Time frame: from the first vaccination through 12 months post the second vaccination
pregnancy events reported by the participants
Time frame: from the first vaccination through 12 months post the second vaccination
Geometric Mean Titer (GMT) of anti-VZV antibody
Time frame: On Day 14 after the completion of the full vaccination course
Geometric Mean Fold Increase (GMFI) of anti-VZV antibody
Time frame: On Day 14 after the completion of the full vaccination course
Seroconversion Rate (SCR) of anti-VZV antibody
Time frame: On Day 14 after the completion of the full vaccination course
cellular immune response
the frequency of peripheral blood mononuclear cell (PBMC) secreting gE-specific cytokines
Time frame: On Day 14 and Day 30 after the completion of the full vaccination course
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.