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

Primary Purpose

Shingles, Herpes Zoster, Vaccine-Preventable Diseases

Status
Completed
Phase
Phase 1
Locations
Australia
Study Type
Interventional
Intervention
Z-1018
Z-1018
Z-1018
Z-1018
Shingrix
Sponsored by
Dynavax Technologies Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Shingles

Eligibility Criteria

50 Years - 69 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Paratus Clinical Research Western Sydney
  • Northern Beaches Clinical Research
  • Paratus Clinical Research Central Coast
  • Emeritus Research Melbourne

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Active Comparator

Arm Label

Z-1018 Dose Level 1

Z-1018 Dose Level 1a

Z-1018 Dose Level 2

Z-1018 Dose Level 2a

Shingrix

Arm Description

100 mcg gE + 3000 mcg CpG 1018

100 mcg gE + 3000 mcg CpG 1018 + alum

100 mcg gE + 6000 mcg CpG 1018

100 mcg gE + 6000 mcg CpG 1018 + alum

Outcomes

Primary Outcome Measures

Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine.
Number of AEs (Adverse Events)
Number of SAEs (Serious Adverse Events)

Secondary Outcome Measures

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

Full Information

First Posted
January 27, 2022
Last Updated
November 3, 2022
Sponsor
Dynavax Technologies Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT05245838
Brief Title
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
November 2022
Overall Recruitment Status
Completed
Study Start Date
January 10, 2022 (Actual)
Primary Completion Date
October 20, 2022 (Actual)
Study Completion Date
October 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dynavax Technologies Corporation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Shingles, Herpes Zoster, Vaccine-Preventable Diseases

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
Participant
Allocation
Randomized
Enrollment
150 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Z-1018 Dose Level 1
Arm Type
Experimental
Arm Description
100 mcg gE + 3000 mcg CpG 1018
Arm Title
Z-1018 Dose Level 1a
Arm Type
Experimental
Arm Description
100 mcg gE + 3000 mcg CpG 1018 + alum
Arm Title
Z-1018 Dose Level 2
Arm Type
Experimental
Arm Description
100 mcg gE + 6000 mcg CpG 1018
Arm Title
Z-1018 Dose Level 2a
Arm Type
Experimental
Arm Description
100 mcg gE + 6000 mcg CpG 1018 + alum
Arm Title
Shingrix
Arm Type
Active Comparator
Intervention Type
Biological
Intervention Name(s)
Z-1018
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Z-1018
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Z-1018
Intervention Description
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
Intervention Type
Biological
Intervention Name(s)
Z-1018
Intervention Description
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)
Intervention Type
Biological
Intervention Name(s)
Shingrix
Intervention Description
a suspension for injection supplied as a single-dose vial of 50 mcg varicella zoster virus (VZV) glycoprotein E (gE) antigen and AS01B adjuvant
Primary Outcome Measure Information:
Title
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine
Time Frame
Day 1 to day 7
Title
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine.
Time Frame
Day 57 to day 63
Title
Number of AEs (Adverse Events)
Time Frame
Day 1 through week 20
Title
Number of SAEs (Serious Adverse Events)
Time Frame
Through week 20
Secondary Outcome Measure Information:
Title
Frequency of CD4+ T cells
Time Frame
At week 12
Title
Measure Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE)
Time Frame
At week 12
Title
Response rate of vaccine
Time Frame
At week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
50 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert Janssen, MD
Organizational Affiliation
Dynavax Technologies Corporation
Official's Role
Study Chair
Facility Information:
Facility Name
Paratus Clinical Research Western Sydney
City
Blacktown
State/Province
New South Wales
ZIP/Postal Code
2148
Country
Australia
Facility Name
Northern Beaches Clinical Research
City
Brookvale
State/Province
New South Wales
ZIP/Postal Code
2100
Country
Australia
Facility Name
Paratus Clinical Research Central Coast
City
Kanwal
State/Province
New South Wales
ZIP/Postal Code
2259
Country
Australia
Facility Name
Emeritus Research Melbourne
City
Camberwell
State/Province
Victoria
ZIP/Postal Code
3124
Country
Australia

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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