ShinglesPhase 1/2NCT06569823
Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over
A Phase 1/2 study testing Z-1018 and Shingrix in people with Shingles and Herpes Zoster, run by Dynavax Technologies Corporation at 16 sites in 2 countries.
Trial summary
This is a randomized, active-controlled, observer-blinded, dose-escalation multi-center trial of 2 doses of an investigational HZ vaccine (Z-1018) in approximately 764 healthy adults. Read more about this study
- Who is it for?
- Ages 50 years and olderHealthy volunteers can take part
- Conditions the study is for
- Shingles, Herpes Zoster, Vaccine-Preventable Diseases
- What is being tested?
- Z-1018 and Shingrix
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 764 participants
- Where
- 16 sitesin 2 countries
- Study dates
- 17 Jun 2024to Jun 2027
- Phase
- Phase 1/2
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Willing to participate; informed consent provided for the study
- Male or female ≥ 50 years of age (Part 1: 50 through 69 years of age, inclusive; Part 2: ≥ 70 years of age
- In good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
- Able to comprehend and follow all required trial procedures and be available for all visits scheduled in the trial
- Seronegative for human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) as assessed during Screening
- 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.
Who cannot join
- History of HZ
- Previous vaccination against varicella (chicken pox) or HZ
- 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)
- Confirmed SARS-CoV-2/COVID-19 infection as assessed during Screening within 7 days of first trial injection.
- If female of childbearing potential, is pregnant (known before or established at the time of screening), breastfeeding, or planning a pregnancy or to breastfeed
- 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
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- History of sensitivity to any component of the trial vaccines
- Has received the following prior to Day 1 trial injection:
- ≤ 14 days: i) Any licensed or authorized inactivated vaccines (including vaccines containing mRNA or CpG)
- ≤ 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
- ≤ 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
- ≤ 6 months before Day 1 (or likely to require during the trial period): i) chronic administration of immunosuppressants or other immune-modifying drugs
- At any time: DNA plasmids or other genetic therapy intended to integrate permanently into host cells
- 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
- 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
- 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)
- Known psychiatric or substance abuse disorder that would interfere with cooperation with the requirements of the trial
- Current or historical autoimmune disease
- 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
- Any other finding that the Investigator considers will make the participant unsuitable for the trial or unable to comply with the trial requirements
Trial locations and contacts
16 sites in 2 countries.
16 sites in 2 countries
Australia11 sites
Veritus Research
Bayswater, Victoria, 3153
Paratus Clinical Research Western Syndney
Blacktown, New South Wales, 2148
Emeritus Research
Botany, New South Wales, 2019
Canopy Clinical Northern Beaches
Brookvale, New South Wales, 2100
Emeritus Research
Camberwell, Victoria, 3124
Doherty Clinical Trials Limited
East Melbourne, Victoria, 3002
Paratus Clinical Research Brisbane
Herston, Queensland, 4006
Paratus Clinical Research Central Coast
Kanwal, New South Wales, 2259
Sutherland Shire Clinical Research
Miranda, New South Wales, 2228
Innovate Clinical Research
Waitara, New South Wales, 2077
Canopy Clinical Wollongong
Wollongong, New South Wales, 2500
New Zealand5 sites
Optimal Clinical Trials Ltd - North
Auckland, 0632
Optimal Clinical Trials Ltd - Central
Auckland, 1010
New Zealand Clinical Research
Christchurch, 8011
Momentum Wellington
Wellington, 0621
Momentum Clinical Research Kapiti
Wellington, 5036
About this study
Official 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 Adult Participants 50 Years of Age and Over
This is a randomized, active-controlled, observer-blinded, dose-escalation multi-center trial of 2 doses of an investigational HZ vaccine (Z-1018) in approximately 764 healthy adults.
Read the detailed description
Part 1 will enroll approximately 440 participants 50 through 69 years of age (YOA) [inclusive] to 1 of 10 arms of Z-1018 or to Shingrix.
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.
- Conditions
- Shingles, Herpes Zoster, Vaccine-Preventable Diseases
- Being tested
- Z-1018, Shingrix
- Medical subject headings
- Herpes Zoster, Vaccine-Preventable Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Z-1018Biological
Formulation for injection
ShingrixBiological
Formulation for injection
| Study group | Role | What they receive |
|---|---|---|
| Z-1018 A1 (Part 1) | Experimental | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85. Receives: Biological: Z-1018 |
| Z-1018 A2 (Part 1) | Experimental | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85. Receives: Biological: Z-1018 |
| Z-1018 B1(a) (Part 1) | Experimental | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57. Receives: Biological: Z-1018 |
| Z-1018 B2(a) (Part 1 and Part 2) | Experimental | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57. Receives: Biological: Z-1018 |
| Z-1018 B1(b) (Part 1) | Experimental | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85 Receives: Biological: Z-1018 |
| Z-1018 B2(b) (Part 1) | Experimental | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85 Receives: Biological: Z-1018 |
| Z-1018 Formulation C1(a) (Part 1) | Experimental | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57. Receives: Biological: Z-1018 |
| Z-1018 Formulation C2(a) (Part 1) | Experimental | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57. Receives: Biological: Z-1018 |
| Z-1018 Formulation C1(b) (Part 1) | Experimental | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85. Receives: Biological: Z-1018 |
| Z-1018 Formulation C2(b) (Part 1) | Experimental | Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85. Receives: Biological: Z-1018 |
| Shingrix (Part 1 and Part 2) | Experimental | Participants will receive a dose of Shingrix by intramuscular (IM) injection on Day 1 and Day 57, or Day 1 and Day 85. Receives: Biological: Shingrix |
What is being measured
The primary outcome is the main question the study is designed to answer.
Part 1 and Part 2: Percentage of participants with solicited local and systemic post-injection reactions (PIRs)
Solicited local and systemic post-injection reactions (PIRs)
Measured: Up to 7 days following each dose
Part 1 and Part 2: Percentage of participants with Adverse events (AEs)
Adverse events (AEs)
Measured: 28 days following each dose
Part 1 and Part 2: Percentage of participants with serious adverse events (SAEs), medically-attended adverse events (MAEs), and immune-mediated adverse events of special interest (imAESIs)
Serious adverse events (SAEs) Medically-attended adverse events (MAEs) Immune-mediated adverse events of special interest (imAESIs)
Measured: Day 1 through 12 months after the last dose of study injection
Part 2: Vaccine response
Composite vaccine response rate in glycoprotein E (gE) -specific CD4+ T cells and anti-gE IgG antibodies in the Per Protocol (PP) population
Measured: 4 weeks after the second study injection
Part 2: Anti-gE IgG antibody concentration
Geometric mean concentration (GMC) and geometric mean ratio of IgG antibodies to varicella-zoster virus (VZV) antigen-gE in the Per Protocol (PP) population
Measured: 4 weeks after the second study injection
Secondary outcomes (5)
Part 1: GMC of IgG antibodies to VZV antigen-gE 4 weeks after the second study injection
GMC to VZV gE in the Per Protocol (PP) population
Measured: 4 weeks after the second study injection
Part 1: Geometric mean ratio (GMR) of IgG antibodies to VZV antigen gE
Geometric mean ratio (GMR) of IgG antibodies to VZV antigen gE in the Per Protocol (PP) population
Measured: 4 weeks after the second study injection
Part 1: Geometric mean fold increase (GMFI) of IgG antibodies to VZV antigen gE
Geometric mean fold increase (GMFI) of IgG antibodies to VZV antigen gE in the Per Protocol (PP) population
Measured: 4 weeks after the second study injection
Part 1 and Part 2: Vaccine response rate (VRR) for anti-gE IgG antibodies to VZV antigen gE
Vaccine response rate (VRR) for anti-gE IgG antibodies to VZV antigen gE in the Per Protocol (PP) population
Measured: 4 weeks after the second study injection
Part 2: VRR for gE-specific CD4+ T cells
VRR for gE-specific CD4+ T cells in the Per Protocol (PP) population
Measured: 4 weeks after second study injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2024
- Study start17 Jun 2024
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ShinglesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 764 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dynavax Technologies Corporation
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06569823
- Sponsor's protocol ID
- DV2-ZOS-02
- Other IDs
- VCF26328
- Status last verified
- Oct 2026
- First submitted
- 8 Jul 2024
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No