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

PHASE1CompletedINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

February 24, 2020

Primary Completion Date

December 3, 2020

Study Completion Date

December 3, 2020

Conditions
Prevention of Herpes Zoster (HZ)
Interventions
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"

Trial Locations (1)

4006,

Q-Pharm Pty Ltd (Nucleus Network), Herston

Sponsors

Lead Sponsor

All Listed Sponsors
collaborator

Novotech (Australia) Pty Limited

INDUSTRY

lead

EyeGene Inc.

OTHER

NCT04210752 - Study to Assess the Safety, Tolerability and Explore the Immunogenicity of EG-HZ in Healthy Adult Volunteers | Biotech Hunter | Biotech Hunter