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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".
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dosage A of zoster mRNA vaccine SYS6017 | Experimental |
| |
| Dosage B of zoster mRNA vaccine SYS6017 | Experimental |
| |
| Dosage C of zoster mRNA vaccine SYS6017 | Experimental |
| |
| Dosage D of zoster mRNA vaccine SYS6017 | Experimental |
| |
| Dosage E of zoster mRNA vaccine SYS6017 | Experimental |
| |
| Placebo | Placebo Comparator |
| |
| Active Comparator Vaccine | Active Comparator |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| A zoster mRNA vaccine SYS6017 | Biological | SYS6017,two-dose vaccination schedule (Month 0, 2) |
|
| Measure | Description | Time Frame |
|---|---|---|
| solicited adverse events | within 14 days post each vaccination | |
| unsolicited adverse events | within 30 days post each vaccination | |
| Geometric Mean Concentration (GMC) of anti-gE antibody | On Day 14 and Day 30 after the completion of the full vaccination course | |
| Geometric Mean Fold Increase (GMFI) of anti-gE antibody | On Day 14 and Day 30 after the completion of the full vaccination course | |
| Seroconversion Rate (SCR) of anti-gE antibody | On Day 14 and Day 30 after the completion of the full vaccination course |
| Measure | Description | Time Frame |
|---|---|---|
| serious adverse events | from the first vaccination through 12 months post the second vaccination | |
| adverse events of special interest | from the first vaccination through 12 months post the second vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Information Group officer | Contact | 86-0311-69085587 | ctr-contact@cspc.cn |
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| ID | Term |
|---|---|
| D006562 | Herpes Zoster |
| ID | Term |
|---|---|
| D000073618 | Varicella Zoster Virus Infection |
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
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Randomized, placebo or active-controlled, Masking
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| Placebo | Other | 0.9% saline,two-dose vaccination schedule (Month 0, 2) |
|
| Active Comparator Vaccine | Biological | Recombinant Zoster Vaccine (CHO cell),two-dose vaccination schedule (Month 0, 2) |
|
| pregnancy events reported by the participants | from the first vaccination through 12 months post the second vaccination |
| Geometric Mean Titer (GMT) of anti-VZV antibody | On Day 14 after the completion of the full vaccination course |
| Geometric Mean Fold Increase (GMFI) of anti-VZV antibody | On Day 14 after the completion of the full vaccination course |
| Seroconversion Rate (SCR) of anti-VZV antibody | 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 | On Day 14 and Day 30 after the completion of the full vaccination course |
| D007239 | Infections |