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

NCT05245838

Phase 1 Completed 150 enrolled Dynavax Technologies Corporation
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

EvaluationDrugModalityDoseRoute
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

Indications