This is a randomized, active-controlled, dose-escalation multi-center study of 2 doses (Day 1 and Week 8) of an investigational herpes zoster (HZ) vaccine (Z-1018), combining herpes zoster antigen- (gE) with a Toll-like receptor 9 (TLR9) agonist adjuvant (CpG 1018) with and without alum in approximately 150 healthy volunteers 50 to 69 years of age (inclusive).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Enrollment
150
contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 3000 mcg
contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 3000 mcg with aluminum hydroxide (alum)
contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 6000 mcg
contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 6000 mcg, with aluminum hydroxide (alum)
a suspension for injection supplied as a single-dose vial of 50 mcg varicella zoster virus (VZV) glycoprotein E (gE) antigen and AS01B adjuvant
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia
Northern Beaches Clinical Research
Brookvale, New South Wales, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia
Emeritus Research Melbourne
Camberwell, Victoria, Australia
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine
Time frame: Day 1 to day 7
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine.
Time frame: Day 57 to day 63
Number of AEs (Adverse Events)
Time frame: Day 1 through week 20
Number of SAEs (Serious Adverse Events)
Time frame: Through week 20
Frequency of CD4+ T cells
Time frame: At week 12
Measure Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE)
Time frame: At week 12
Response rate of vaccine
Time frame: At week 12
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