Clinical trial NCT04210752: Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-HZ in Healthy Adult Volunteers
Official title: 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
Conditions: Prevention of Herpes Zoster (HZ)
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).
Interventions:
description: 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)<br/>Route of Administration: IM injection
name: Treatment 1 (EG-HZ-001)
other_name: EG-HZ
type: Drug
description: 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)<br/>Route of Administration: IM injection
name: Treatment 2 (EG-HZ-002)
other_name: EG-HZ
type: Drug
description: 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)<br/>Route of Administration: IM injection
name: Treatment 3 (EG-HZ-003)
other_name: EG-HZ
type: Drug
description: 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)<br/>Route of Administration: IM injection
name: Treatment 4 (EG-HZ-004)
other_name: EG-HZ
type: Drug
description: Shingrix<br/>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.<br/>Route of Administration: IM injection
name: Treatment 5
other_name: Comparator
type: Drug
Study arms:
design_group_description: 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)<br/>Route of administration: Intramuscular injection
design_group_title: Treatment 1 (EG-HZ-001)
design_group_type: Experimental
design_group_description: 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)<br/>Route of administration: Intramuscular injection
design_group_title: Treatment 2 (EG-HZ-002)
design_group_type: Experimental
design_group_description: 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)<br/>Route of administration: Intramuscular injection
design_group_title: Treatment 3 (EG-HZ-003)
design_group_type: Experimental
design_group_description: 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)<br/>Route of administration: Intramuscular injection
design_group_title: Treatment 4 (EG-HZ-004)
design_group_type: Experimental
design_group_description: Shingrix<br/>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.<br/>Route of Administration: Intramuscular injection
design_group_title: Treatment 5 (Shingrix)
design_group_type: Experimental
Sponsor: EyeGene, Inc.
Collaborators: Novotech (Australia) Pty Ltd.
Drug name mappings:
name: Herpes zoster vaccine(EyeGene, Inc.)
lang: EN