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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06569823




Registration number
NCT06569823
Ethics application status
Date submitted
8/07/2024
Date registered
26/08/2024

Titles & IDs
Public title
Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults
Scientific title
A Phase 1/2 Randomized, Observer-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 Adults
Secondary ID [1] 0 0
DV2-ZOS-02
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
Treatment: Other - Z-1018
Treatment: Other - Shingrix

Experimental: Z-1018 A1 - Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85.

Experimental: Z-1018 A2 - Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85.

Experimental: Z-1018 B1(a) - Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57.

Experimental: Z-1018 B2(a) - Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57.

Experimental: Z-1018 B1(b) - Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85

Experimental: Z-1018 B2(b) - Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85

Experimental: Z-1018 Formulation C1(a) - Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57.

Experimental: Z-1018 Formulation C2(a) - Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57.

Experimental: Z-1018 Formulation C1(b) - Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85.

Experimental: Z-1018 Formulation C2(b) - Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85.

Experimental: Shingrix - Participants will receive a dose of Shingrix by intramuscular (IM) injection on Day 1 and Day 57, or Day 1 and Day 85.


Treatment: Other: Z-1018
Formulation for injection

Treatment: Other: Shingrix
Formulation for injection
Intervention code [1] 0 0
Treatment: Other
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of participants with solicited local and systemic post-injection reactions (PIRs)
Timepoint [1] 0 0
Up to 7 days following each dose
Primary outcome [2] 0 0
Percentage of participants with Adverse events (AEs)
Timepoint [2] 0 0
28 days following each dose
Primary outcome [3] 0 0
Percentage of participants with serious adverse events (SAEs), medically-attended adverse events (MAEs), and immune-mediated adverse events of special interest (imAESIs)
Timepoint [3] 0 0
Day 1 through 12 months after the last dose of study injection
Secondary outcome [1] 0 0
Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE) 4 weeks after the second study injection
Timepoint [1] 0 0
4 weeks after the second study injection
Secondary outcome [2] 0 0
Geometric mean ratio (GMR) of IgG antibodies to VZV antigen gE
Timepoint [2] 0 0
4 weeks after the second study injection
Secondary outcome [3] 0 0
Geometric mean fold increase (GMFI) of IgG antibodies to VZV antigen gE
Timepoint [3] 0 0
4 weeks after the second study injection
Secondary outcome [4] 0 0
Vaccine response rate (VRR) for anti-gE IgG antibodies to VZV antigen gE
Timepoint [4] 0 0
4 weeks after the second study injection

Eligibility
Key inclusion criteria
A subject must meet all of the following criteria to be eligible for enrollment (defined as receiving any study vaccine) in the study:

1. Male or female, 50 to 69 years of age
2. Be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
3. Must be able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
4. 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
A subject with any 1 of the following criteria is not eligible for enrollment (defined as receiving any study vaccine) in the study:

1. History of HZ
2. Previous vaccination against varicella or HZ
3. If female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
4. Known history of HIV (HIV 1/2 antibodies)
5. Has a history of sensitivity to any component of study vaccines
6. 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
7. 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
8. Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose
9. 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
10. 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
11. 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


The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
17/06/2024
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2026
Actual
Sample size
Target
440
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW
Recruitment hospital [1] 0 0
Northern Beaches Clinical Research - Brookvale
Recruitment postcode(s) [1] 0 0
2100 - Brookvale

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

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
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
Ouzama Henry, MD
Address 0 0
Country 0 0
Phone 0 0
+1 617 686 4796
Fax 0 0
Email 0 0
ohenry@dynavax.com
Contact person for scientific queries

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT06569823