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

NCT ID: NCT05245838

Last Updated: 2022-11-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-01-10
• Study Completion Date: 2022-10-20

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).

Conditions

Shingles; Herpes Zoster; Vaccine-Preventable Diseases

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: SINGLE

Study Groups

Z-1018 Dose Level 1

100 mcg gE + 3000 mcg CpG 1018

Group Type: EXPERIMENTAL

Z-1018

Intervention Type: BIOLOGICAL

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

Z-1018 Dose Level 1a

100 mcg gE + 3000 mcg CpG 1018 + alum

Group Type: EXPERIMENTAL

Z-1018

Intervention Type: BIOLOGICAL

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)

Z-1018 Dose Level 2

100 mcg gE + 6000 mcg CpG 1018

Group Type: EXPERIMENTAL

Z-1018

Intervention Type: BIOLOGICAL

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

Z-1018 Dose Level 2a

100 mcg gE + 6000 mcg CpG 1018 + alum

Group Type: EXPERIMENTAL

Z-1018

Intervention Type: BIOLOGICAL

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)

Shingrix

Group Type: ACTIVE_COMPARATOR

Shingrix

Intervention Type: BIOLOGICAL

a suspension for injection supplied as a single-dose vial of 50 mcg varicella zoster virus (VZV) glycoprotein E (gE) antigen and AS01B adjuvant

Interventions

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

Intervention Type: 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)

Intervention Type: 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

Intervention Type: 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)

Intervention Type: 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

Intervention Type: BIOLOGICAL

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

• Minimum Eligible Age: 50 Years
• Maximum Eligible Age: 69 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Dynavax Technologies Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robert Janssen, MD

Role: STUDY_CHAIR

Dynavax Technologies Corporation

Locations

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

Countries

Australia

References

de Oliveira Gomes J, Gagliardi AM, Andriolo BN, Torloni MR, Andriolo RB, Puga MEDS, Canteiro Cruz E. Vaccines for preventing herpes zoster in older adults. Cochrane Database Syst Rev. 2023 Oct 2;10(10):CD008858. doi: 10.1002/14651858.CD008858.pub5.

Reference Type: DERIVED

PMID: 37781954 (View on PubMed)

Other Identifiers

DV2-ZOS-01

Identifier Type: -

Identifier Source: org_study_id