NCT06569823

Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over

A Phase 1/2 Randomized, Observer-Blinded, Active-Controlled, Dose, Escalation Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Participants 50 Years of Age and Over

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 764 (estimated)
• Sponsor: Dynavax Technologies Corporation · Industry
• Sex: All
• Age: 50 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, active-controlled, observer-blinded, dose-escalation multi-center trial of 2 doses of an investigational HZ vaccine (Z-1018) in approximately 764 healthy adults.

Detailed description

Part 1 will enroll approximately 440 participants 50 through 69 years of age (YOA) \[inclusive\] to 1 of 10 arms of Z-1018 or to Shingrix. Part 2 will enroll approximately 324 participants ≥ 70 YOA to 1 arm of Z-1018 (selected from Part 1) to be administered in a 1:1 randomization ratio with Shingrix. Part 2 only: after completing the 12-month post-vaccination visit, Part 2 participants will be followed for an additional 4 years for immunopersistence and for herpes zoster (HZ) and post herpetic neuralgia (PHN).

Conditions

• Shingles
• Herpes Zoster
• Vaccine-Preventable Diseases

Interventions

Type	Name	Description
BIOLOGICAL	Z-1018	Formulation for injection
BIOLOGICAL	Shingrix	Formulation for injection

Timeline

• Start date: 2024-06-17
• Primary completion: 2027-11-01
• Completion: 2031-11-01
• First posted: 2024-08-26
• Last updated: 2025-11-06

Locations

13 sites across 2 countries: Australia, New Zealand

Regulatory

• FDA-regulated drug study