Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over
NCT ID: NCT06569823
Last Updated: 2025-11-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1/PHASE2
764 participants
INTERVENTIONAL
2024-06-17
2031-11-30
Brief Summary
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Detailed Description
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Part 2 will enroll approximately 324 participants ≥ 70 YOA to 1 arm of Z-1018 (selected from Part 1) to be administered in a 1:1 randomization ratio with Shingrix. Part 2 only: after completing the 12-month post-vaccination visit, Part 2 participants will be followed for an additional 4 years for immunopersistence and for herpes zoster (HZ) and post herpetic neuralgia (PHN).
Conditions
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
DOUBLE
Study Groups
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Z-1018 A1 (Part 1)
Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85.
Z-1018
Formulation for injection
Z-1018 A2 (Part 1)
Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85.
Z-1018
Formulation for injection
Z-1018 B1(a) (Part 1)
Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57.
Z-1018
Formulation for injection
Z-1018 B2(a) (Part 1 and Part 2)
Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57.
Z-1018
Formulation for injection
Z-1018 B1(b) (Part 1)
Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85
Z-1018
Formulation for injection
Z-1018 B2(b) (Part 1)
Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85
Z-1018
Formulation for injection
Z-1018 Formulation C1(a) (Part 1)
Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57.
Z-1018
Formulation for injection
Z-1018 Formulation C2(a) (Part 1)
Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57.
Z-1018
Formulation for injection
Z-1018 Formulation C1(b) (Part 1)
Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85.
Z-1018
Formulation for injection
Z-1018 Formulation C2(b) (Part 1)
Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85.
Z-1018
Formulation for injection
Shingrix (Part 1 and Part 2)
Participants will receive a dose of Shingrix by intramuscular (IM) injection on Day 1 and Day 57, or Day 1 and Day 85.
Shingrix
Formulation for injection
Interventions
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Z-1018
Formulation for injection
Shingrix
Formulation for injection
Eligibility Criteria
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Inclusion Criteria
2. Male or female ≥ 50 years of age (Part 1: 50 through 69 years of age, inclusive; Part 2: ≥ 70 years of age
3. In good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
4. Able to comprehend and follow all required trial procedures and be available for all visits scheduled in the trial
5. Seronegative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) as assessed during Screening
6. If female of child-bearing potential and heterosexually active, has practiced adequate contraception for at least 28 days prior to vaccination, has negative pregnancy tests just prior to vaccination, and has agreed to continue adequate contraception through 3 months following the final study injection.
Exclusion Criteria
2. Previous vaccination against varicella (chicken pox) or HZ
3. Febrile illness within 7 days of the first trial injection (defined as at least 1 measured body temperature of ≥ 38°C, regardless of route of measurement)
4. Confirmed SARS-CoV-2/COVID-19 infection as assessed during Screening within 7 days of first trial injection.
5. If female of childbearing potential, is pregnant (known before or established at the time of screening), breastfeeding, or planning a pregnancy or to breastfeed
6. Known or suspected immunodeficiency (including but not limited to HIV/AIDS), or immunocompromised state, as assessed by medical history, past or current laboratory studies, and/or physical examination
7. History of sensitivity to any component of the trial vaccines
8. Has received the following prior to Day 1 trial injection:
a) ≤ 14 days: i) Any licensed or authorized inactivated vaccines (including vaccines containing mRNA or CpG)
b) ≤ 28 days: i) Any live vaccine ii) Systemic corticosteroids (≥ 20 mg/ day of prednisone or equivalent for more than 14 consecutive days) or other immunomodulators or immune suppressive medication, with the exception of inhaled steroids iii) Any investigational medicinal agent
c) ≤ 90 days: i) Granulocyte or granulocyte-macrophage colony-stimulating factor ii) Immunoglobulins or any blood products (receipt of certain monoclonal antibodies may on a case-by-case basis be non-exclusionary if approved via consultation with Sponsor Medical Monitor) iii) Antisense oligonucleotides iv) Drugs/investigational agents with very long half-lives (defined as ≥ 60 days) (eg, radioactive iodine-125, amiodarone, nirsevimab, and evinacumab) v) Infusion of blood products
d) ≤ 6 months before Day 1 (or likely to require during the trial period): i) chronic administration of immunosuppressants or other immune-modifying drugs
e) At any time: DNA plasmids or other genetic therapy intended to integrate permanently into host cells
9. Is undergoing chemotherapy or expected to receive chemotherapy during the trial period; and/or 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, laboratory abnormality, or other finding that might confound the results of the trial, interfere with the participant's participation for the full duration of the trial, or is not in the best interest of the participant to participate, in the opinion of the treating investigator
11. Underlying chronic medical condition requiring ongoing follow-up and monitoring by a healthcare provider that might affect the immune response to vaccine (eg, diabetes mellitus, chronic kidney disease)
12. Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
13. Current or historical autoimmune disease
14. Any skin condition and/or tattoo on both arms that may interfere with the evaluation of safety at the injection site, in the opinion of the treating investigator
15. Any other finding that the Investigator considers will make the participant unsuitable for the trial or unable to comply with the trial requirements
50 Years
ALL
Yes
Sponsors
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Dynavax Technologies Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Robert Janssen, MD
Role: STUDY_CHAIR
Dynavax Technologies Corporation
Locations
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Emeritus Research
Botany, New South Wales, Australia
Canopy Clinical Northern Beaches
Brookvale, New South Wales, Australia
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia
Sutherland Shire Clinical Research
Miranda, New South Wales, Australia
Innovate Clinical Research
Waitara, New South Wales, Australia
Canopy Clinical Wollongong
Wollongong, New South Wales, Australia
Paratus Clinical Research Brisbane
Herston, Queensland, Australia
Momentum Clinical Research Wellers Hill
Tarragindi, Queensland, Australia
Veritus Research
Bayswater, Victoria, Australia
Emeritus Research
Camberwell, Victoria, Australia
Optimal Clinical Trials Ltd - North
Auckland, , New Zealand
Optimal Clinical Trials Ltd - Central
Auckland, , New Zealand
Momentum Wellington
Wellington, , New Zealand
Countries
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Central Contacts
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Facility Contacts
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Fiona Kilkenny
Role: primary
Noris Scaglia
Role: primary
Elizabeth A Gunner
Role: primary
Melissa Nemeth
Role: primary
Rachel C Graham
Role: primary
Emily C Brine
Role: primary
Alexander R Bates
Role: backup
Steve W Turner
Role: primary
Natalie A Sullivan
Role: primary
Swati Dawar
Role: primary
Rishi Shah
Role: primary
Claudette Lionnet
Role: primary
Byju Sacheendran
Role: primary
Dean R Quinn
Role: primary
Other Identifiers
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DV2-ZOS-02
Identifier Type: -
Identifier Source: org_study_id