A Phase 1 interventional study of Z-1018 and Z-1018 in Shingles, Herpes Zoster and Vaccine-Preventable Diseases, sponsored by Dynavax Technologies Corporation. Completed at 4 sites in Australia. Open to participants aged 50 Years to 69 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2022-11-07.
Sponsored by Dynavax Technologies Corporation · Phase 1, Interventional, and Prevention
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).
305 studies on the registry are indexed under Herpes Simplex; 31 are open to participants now.
This study's enrollment of 150 is above the median of 101 across 227 interventional studies indexed under Herpes Simplex.
Browse Herpes Simplex studies →Dynavax Technologies Corporation is the lead sponsor of 25 studies on the registry; none are open to participants now.
Of its 7 completed or terminated interventional studies of FDA-regulated products, 6 (86%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Has received the following prior to the first injection:
100 mcg gE + 3000 mcg CpG 1018
Biological: Z-1018
100 mcg gE + 3000 mcg CpG 1018 + alum
Biological: Z-1018
100 mcg gE + 6000 mcg CpG 1018
Biological: Z-1018
100 mcg gE + 6000 mcg CpG 1018 + alum
Biological: Z-1018
Biological: Shingrix
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
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
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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Dynavax Technologies Corporation