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
1 other identifier
interventional
150
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Jan 2022
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 10, 2022
CompletedFirst Submitted
Initial submission to the registry
January 27, 2022
CompletedFirst Posted
Study publicly available on registry
February 18, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 20, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
October 20, 2022
CompletedNovember 7, 2022
November 1, 2022
9 months
January 27, 2022
November 3, 2022
Conditions
Outcome Measures
Primary Outcomes (4)
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 Outcomes (3)
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
Study Arms (5)
Z-1018 Dose Level 1
EXPERIMENTAL100 mcg gE + 3000 mcg CpG 1018
Z-1018 Dose Level 1a
EXPERIMENTAL100 mcg gE + 3000 mcg CpG 1018 + alum
Z-1018 Dose Level 2
EXPERIMENTAL100 mcg gE + 6000 mcg CpG 1018
Z-1018 Dose Level 2a
EXPERIMENTAL100 mcg gE + 6000 mcg CpG 1018 + alum
Shingrix
ACTIVE COMPARATORInterventions
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
a suspension for injection supplied as a single-dose vial of 50 mcg varicella zoster virus (VZV) glycoprotein E (gE) antigen and AS01B adjuvant
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- 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:
- days: any non-live vaccine
- 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
- +2 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, 2148, Australia
Northern Beaches Clinical Research
Brookvale, New South Wales, 2100, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, 2259, Australia
Emeritus Research Melbourne
Camberwell, Victoria, 3124, Australia
Related Publications (1)
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.
PMID: 37781954DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Robert Janssen, MD
Dynavax Technologies Corporation
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2022
First Posted
February 18, 2022
Study Start
January 10, 2022
Primary Completion
October 20, 2022
Study Completion
October 20, 2022
Last Updated
November 7, 2022
Record last verified: 2022-11
Data Sharing
- IPD Sharing
- Will not share