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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05245838




Registration number
NCT05245838
Ethics application status
Date submitted
27/01/2022
Date registered
18/02/2022
Date last updated
7/11/2022

Titles & IDs
Public title
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers
Scientific 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
Secondary ID [1] 0 0
DV2-ZOS-01
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Shingles 0 0
Herpes Zoster 0 0
Vaccine-Preventable Diseases 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Skin 0 0 0 0
Other skin conditions
Inflammatory and Immune System 0 0 0 0
Normal development and function of the immune system
Infection 0 0 0 0
Studies of infection and infectious agents

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Other interventions - Z-1018
Other interventions - Z-1018
Other interventions - Z-1018
Other interventions - Z-1018
Other interventions - Shingrix

Experimental: Z-1018 Dose Level 1 - 100 mcg gE + 3000 mcg CpG 1018

Experimental: Z-1018 Dose Level 1a - 100 mcg gE + 3000 mcg CpG 1018 + alum

Experimental: Z-1018 Dose Level 2 - 100 mcg gE + 6000 mcg CpG 1018

Experimental: Z-1018 Dose Level 2a - 100 mcg gE + 6000 mcg CpG 1018 + alum

Active Comparator: Shingrix -


Other 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

Other 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 with aluminum hydroxide (alum)

Other 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 6000 mcg

Other 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 6000 mcg, with aluminum hydroxide (alum)

Other interventions: 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 code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine
Timepoint [1] 0 0
Day 1 to day 7
Primary outcome [2] 0 0
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine.
Timepoint [2] 0 0
Day 57 to day 63
Primary outcome [3] 0 0
Number of AEs (Adverse Events)
Timepoint [3] 0 0
Day 1 through week 20
Primary outcome [4] 0 0
Number of SAEs (Serious Adverse Events)
Timepoint [4] 0 0
Through week 20
Secondary outcome [1] 0 0
Frequency of CD4+ T cells
Timepoint [1] 0 0
At week 12
Secondary outcome [2] 0 0
Measure Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE)
Timepoint [2] 0 0
At week 12
Secondary outcome [3] 0 0
Response rate of vaccine
Timepoint [3] 0 0
At week 12

Eligibility
Key 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)
Minimum age
50 Years
Maximum age
69 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key 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 design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Other
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
10/01/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
20/10/2022
Sample size
Target
Accrual to date
Final
150
Recruitment in Australia
Recruitment state(s)
NSW,VIC
Recruitment hospital [1] 0 0
Paratus Clinical Research Western Sydney - Blacktown
Recruitment hospital [2] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment hospital [3] 0 0
Paratus Clinical Research Central Coast - Kanwal
Recruitment hospital [4] 0 0
Emeritus Research Melbourne - Camberwell
Recruitment postcode(s) [1] 0 0
2148 - Blacktown
Recruitment postcode(s) [2] 0 0
2100 - Brookvale
Recruitment postcode(s) [3] 0 0
2259 - Kanwal
Recruitment postcode(s) [4] 0 0
3124 - Camberwell

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Dynavax Technologies Corporation
Address
Country

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT05245838
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Robert Janssen, MD
Address 0 0
Dynavax Technologies Corporation
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries