Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers

A Phase 1 Randomized, Subject-Blinded, Active-Controlled, Dose Escalation, Multicenter Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers Between the Ages of 50 and 69 Years

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 Overview

• Status: Completed
• Conditions: Herpes Zoster; Vaccine-Preventable Diseases; Shingles
• Intervention / Treatment: Biological: Z-1018; Biological: Z-1018; Biological: Z-1018; Biological: Z-1018; Biological: Shingrix

• Study Type: Interventional
• Enrollment (Actual): 150
• Phase: Phase 1

Contacts and Locations

Study Locations

• Australia
  • New South Wales
    • Blacktown, New South Wales, Australia, 2148
      • Paratus Clinical Research Western Sydney
    • Brookvale, New South Wales, Australia, 2100
      • Northern Beaches Clinical Research
    • Kanwal, New South Wales, Australia, 2259
      • Paratus Clinical Research Central Coast
  • Victoria
    • Camberwell, Victoria, Australia, 3124
      • Emeritus Research Melbourne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 48 years to 67 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Male or female, 50 to 69 years of age
• Be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
• Must be able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
• Seronegative for human immunodeficiency virus (HIV)

Exclusion Criteria:

• History of HZ
• Previous vaccination against varicella or HZ
• If female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
• Known history of HIV (HIV 1/2 antibodies)
• Has a history of sensitivity to any component of study vaccines
• Has received any blood products or immunoglobulin within 90 days prior to study injection, or is likely to require infusion of blood products during the study period

• Has received the following prior to the first injection:

  • 14 days: any non-live vaccine
  • 28 days:
  • Any live vaccine, including a COVID-19 vaccine
  • Systemic corticosteroids (more than 3 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids
  • Granulocyte or granulocyte-macrophage colony-stimulating factor
  • Any other investigational medicinal agent, including a COVID-19 vaccine
• Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose
• Is undergoing chemotherapy or expected to receive chemotherapy during the study period; has a diagnosis of cancer within the last 5 years other than squamous cell or basal cell carcinoma of the skin
• History or current evidence of any condition, therapy, or laboratory abnormality that might confound the results of the study, interfere with the subject's participation for the full duration of the study, or is not in the best interest of the subject to participate, in the opinion of the treating investigator
• History of autoimmune disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Prevention
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Z-1018 Dose Level 1; 100 mcg gE + 3000 mcg CpG 1018	Biological: Z-1018; 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; Biological: Z-1018; 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); Biological: Z-1018; 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; Biological: Z-1018; 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)
Experimental: Z-1018 Dose Level 1a; 100 mcg gE + 3000 mcg CpG 1018 + alum	Biological: Z-1018; 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; Biological: Z-1018; 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); Biological: Z-1018; 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; Biological: Z-1018; 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)
Experimental: Z-1018 Dose Level 2; 100 mcg gE + 6000 mcg CpG 1018	Biological: Z-1018; 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; Biological: Z-1018; 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); Biological: Z-1018; 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; Biological: Z-1018; 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)
Experimental: Z-1018 Dose Level 2a; 100 mcg gE + 6000 mcg CpG 1018 + alum	Biological: Z-1018; 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; Biological: Z-1018; 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); Biological: Z-1018; 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; Biological: Z-1018; 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)
Active Comparator: Shingrix	Biological: Shingrix; a suspension for injection supplied as a single-dose vial of 50 mcg varicella zoster virus (VZV) glycoprotein E (gE) antigen and AS01B adjuvant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine	Day 1 to day 7
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine.	Day 57 to day 63
Number of AEs (Adverse Events)	Day 1 through week 20
Number of SAEs (Serious Adverse Events)	Through week 20

Secondary Outcome Measures

Outcome Measure	Time Frame
Frequency of CD4+ T cells	At week 12
Measure Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE)	At week 12
Response rate of vaccine	At week 12

Collaborators and Investigators

• Sponsor: Dynavax Technologies Corporation
• Investigators: Study Chair: Robert Janssen, MD, Dynavax Technologies Corporation

Study record dates

Study Major Dates

• Study Start (Actual): January 10, 2022
• Primary Completion (Actual): October 20, 2022
• Study Completion (Actual): October 20, 2022

Study Registration Dates

• First Submitted: January 27, 2022
• First Submitted That Met QC Criteria: February 8, 2022
• First Posted (Actual): February 18, 2022

Study Record Updates

• Last Update Posted (Actual): November 7, 2022
• Last Update Submitted That Met QC Criteria: November 3, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Virus Diseases; Infections; DNA Virus Infections; Skin Diseases, Infectious; Skin Diseases, Viral; Herpesviridae Infections; Varicella Zoster Virus Infection; Herpes Zoster; Herpes Simplex; Vaccine-Preventable Diseases
• Other Study ID Numbers: DV2-ZOS-01

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No