Investigating a new herpes zoster vaccine in healthy adults

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 study is testing a new herpes zoster vaccine in healthy adults aged 50 to 69 to see if it is safe and works as well as the current Shingrix vaccine.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 764 (estimated)
• Ages: 50 Years and up
• Sex: All
• Sponsor: Dynavax Technologies Corporation (industry)
• Drugs / interventions: nirsevimab, evinacumab, chemotherapy, prednisone
• Locations: 13 sites (Botany, New South Wales and 12 other locations)
• Trial ID: NCT06569823 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the safety and immunogenicity of an investigational herpes zoster vaccine, Z-1018, compared to the established Shingrix vaccine. It is a randomized, active-controlled, observer-blinded, dose-escalation trial involving approximately 440 healthy adults aged 50 to 69. Participants will receive two doses of the investigational vaccine or Shingrix, and their health will be monitored to assess the vaccine's effectiveness and safety profile.

Who should consider this trial

Good fit: Ideal candidates are healthy adults aged 50 to 69 who have not previously had herpes zoster or been vaccinated against it.

Not a fit: Patients with a history of herpes zoster or previous vaccination against varicella or herpes zoster may not benefit from this study.

Why it matters

Potential benefit: If successful, this vaccine could provide a new option for preventing shingles in older adults.

How similar studies have performed: Other studies have shown success with similar vaccine approaches, indicating potential for this investigational vaccine.

Eligibility criteria

Inclusion Criteria:

1. Willing to participate; informed consent provided for the study
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:

1. History of HZ
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

Where this trial is running

Botany, New South Wales and 12 other locations

• Emeritus Research — Botany, New South Wales, Australia (RECRUITING)
• Canopy Clinical Northern Beaches — Brookvale, New South Wales, Australia (RECRUITING)
• Paratus Clinical Research Central Coast — Kanwal, New South Wales, Australia (RECRUITING)
• Sutherland Shire Clinical Research — Miranda, New South Wales, Australia (RECRUITING)
• Innovate Clinical Research — Waitara, New South Wales, Australia (RECRUITING)
• Canopy Clinical Wollongong — Wollongong, New South Wales, Australia (RECRUITING)
• Paratus Clinical Research Brisbane — Herston, Queensland, Australia (RECRUITING)
• Momentum Clinical Research Wellers Hill — Tarragindi, Queensland, Australia (RECRUITING)
• Veritus Research — Bayswater, Victoria, Australia (RECRUITING)
• Emeritus Research — Camberwell, Victoria, Australia (RECRUITING)
• Optimal Clinical Trials Ltd - North — Auckland, New Zealand (NOT_YET_RECRUITING)
• Optimal Clinical Trials Ltd - Central — Auckland, New Zealand (NOT_YET_RECRUITING)
• Momentum Wellington — Wellington, New Zealand (NOT_YET_RECRUITING)

Study contacts

• Study coordinator: Ouzama Henry, MD

Conditions: Shingles, Herpes Zoster, Vaccine-Preventable Diseases