drugset / Trial / NCT05245838
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers
RandomizedSequentialSingle-blindPrevention
Summary
This is a randomized, active-controlled, dose-escalation multi-center study of 2 doses (Day 1 and Week 8) of an investigational herpes zoster (HZ) vaccine (Z-1018), combining herpes zoster antigen- (gE) with a Toll-like receptor 9 (TLR9) agonist adjuvant (CpG 1018) with and without alum in approximately 150 healthy volunteers 50 to 69 years of age (inclusive).
Timeline
- Start
- 2022-01-10
- Primary completion
- 2022-10-20
- Completion
- 2022-10-20
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | VARICELLA ZOSTER VIRUS ENVELOPE GLYCOPROTEIN E | Vaccine | 50 ug | — |
| Subject | Z-1018 | Vaccine | 100 ug | — |
| Subject | Z-1018 | Vaccine | 3000 ug | — |
| Subject | Z-1018 | Vaccine | 6000 ug | — |