NCT04210752

Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-HZ in Healthy Adult Volunteers

A Phase 1, Randomised, Activator-Controlled, Double-Blind, Parallel Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-HZ in Healthy Adult Volunteers

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: EyeGene Inc. · Academic / Other
• Sex: All
• Age: 50 Years – 70 Years
• Healthy volunteers: Accepted

Summary

This is a Phase 1, first in human (FIH), randomised, active-controlled, double-blind study designed to assess the safety and tolerability and explore preliminary efficacy of the EG-HZ vaccine. Oversight will be provided by a Safety Review Committee (SRC).

Detailed description

Subjects will undergo a Screening period beginning up to 28 days prior to randomisation, the first of two vaccinations administered 2 months apart, pre- and post-dose assessment, follow-up visits, and an end of study (EOS) or early termination (ET) visit (as applicable). Subjects will be randomised prior to vaccination on Day 1, to one (1) of five (5) treatment groups.

Conditions

• Prevention of Herpes Zoster (HZ)

Interventions

Type	Name	Description
DRUG	Treatment 1 (EG-HZ-001)	Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment) Route of Administration: IM injection
DRUG	Treatment 2 (EG-HZ-002)	Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment) Route of Administration: IM injection
DRUG	Treatment 3 (EG-HZ-003)	Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment) Route of Administration: IM injection
DRUG	Treatment 4 (EG-HZ-004)	Subjects will receive two single IM vaccinations, 2 months apart, the first on Day 1 and the second on Day 60 (±5 days). Subjects will be randomised to treatment at a ratio of 1:1:1:1:1 (n=8 per treatment) Route of Administration: IM injection
DRUG	Treatment 5	Shingrix Suspension for injection supplied as a single dose vial of lyophilised VZVgE antigen component to be reconstituted with the accompanying vial of AS01B adjuvant suspension component. After reconstitution, a single dose of ShingrixTM is 0.5 mL. Route of Administration: IM injection

Timeline

• Start date: 2020-02-24
• Primary completion: 2020-12-03
• Completion: 2020-12-03
• First posted: 2019-12-26
• Last updated: 2021-02-08

Locations

1 site across 1 country: Australia