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

Herpes Zoster Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05245838
• Other study ID #: DV2-ZOS-01
• Status: Completed
• Phase: Phase 1
• Start date: January 10, 2022
• Est. completion date: October 20, 2022

Study information

• Verified date: November 2022
• Source: Dynavax Technologies Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 150
• Est. completion date: October 20, 2022
• Est. primary completion date: October 20, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 50 Years to 69 Years

Eligibility

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

Related Conditions & MeSH terms

• Herpes Simplex
• Herpes Zoster
• Shingles

Intervention

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
• 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)
• 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
• 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)
• 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

Locations

Country	Name	City	State
Australia	Paratus Clinical Research Western Sydney	Blacktown	New South Wales
Australia	Northern Beaches Clinical Research	Brookvale	New South Wales
Australia	Emeritus Research Melbourne	Camberwell	Victoria
Australia	Paratus Clinical Research Central Coast	Kanwal	New South Wales

Sponsors (1)

Lead Sponsor	Collaborator
Dynavax Technologies Corporation

Country where clinical trial is conducted

Australia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine		Day 1 to day 7
Primary	Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine.		Day 57 to day 63
Primary	Number of AEs (Adverse Events)		Day 1 through week 20
Primary	Number of SAEs (Serious Adverse Events)		Through week 20
Secondary	Frequency of CD4+ T cells		At week 12
Secondary	Measure Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE)		At week 12
Secondary	Response rate of vaccine		At week 12