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.
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).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Enrollment
764
Emeritus Research
Botany, New South Wales, Australia
RECRUITINGCanopy Clinical Northern Beaches
Brookvale, New South Wales, Australia
Part 1 and Part 2: Percentage of participants with solicited local and systemic post-injection reactions (PIRs)
Solicited local and systemic post-injection reactions (PIRs)
Time frame: Up to 7 days following each dose
Part 1 and Part 2: Percentage of participants with Adverse events (AEs)
Adverse events (AEs)
Time frame: 28 days following each dose
Part 1 and Part 2: Percentage of participants with serious adverse events (SAEs), medically-attended adverse events (MAEs), and immune-mediated adverse events of special interest (imAESIs)
Serious adverse events (SAEs) Medically-attended adverse events (MAEs) Immune-mediated adverse events of special interest (imAESIs)
Time frame: Day 1 through 12 months after the last dose of study injection
Part 2: Vaccine response
Composite vaccine response rate in glycoprotein E (gE) -specific CD4+ T cells and anti-gE IgG antibodies in the Per Protocol (PP) population
Time frame: 4 weeks after the second study injection
Part 2: Anti-gE IgG antibody concentration
Geometric mean concentration (GMC) and geometric mean ratio of IgG antibodies to varicella-zoster virus (VZV) antigen-gE in the Per Protocol (PP) population
Time frame: 4 weeks after the second study injection
Part 1: GMC of IgG antibodies to VZV antigen-gE 4 weeks after the second study injection
GMC to VZV gE in the Per Protocol (PP) population
Time frame: 4 weeks after the second study injection
Part 1: Geometric mean ratio (GMR) of IgG antibodies to VZV antigen gE
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Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia
RECRUITINGSutherland Shire Clinical Research
Miranda, New South Wales, Australia
RECRUITINGInnovate Clinical Research
Waitara, New South Wales, Australia
RECRUITINGCanopy Clinical Wollongong
Wollongong, New South Wales, Australia
RECRUITINGParatus Clinical Research Brisbane
Herston, Queensland, Australia
RECRUITINGMomentum Clinical Research Wellers Hill
Tarragindi, Queensland, Australia
RECRUITINGVeritus Research
Bayswater, Victoria, Australia
RECRUITINGEmeritus Research
Camberwell, Victoria, Australia
RECRUITING...and 3 more locations
Geometric mean ratio (GMR) of IgG antibodies to VZV antigen gE in the Per Protocol (PP) population
Time frame: 4 weeks after the second study injection
Part 1: Geometric mean fold increase (GMFI) of IgG antibodies to VZV antigen gE
Geometric mean fold increase (GMFI) of IgG antibodies to VZV antigen gE in the Per Protocol (PP) population
Time frame: 4 weeks after the second study injection
Part 1 and Part 2: Vaccine response rate (VRR) for anti-gE IgG antibodies to VZV antigen gE
Vaccine response rate (VRR) for anti-gE IgG antibodies to VZV antigen gE in the Per Protocol (PP) population
Time frame: 4 weeks after the second study injection
Part 2: VRR for gE-specific CD4+ T cells
VRR for gE-specific CD4+ T cells in the Per Protocol (PP) population
Time frame: 4 weeks after second study injection