Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over

NCT06569823 | Active Not Recruiting Phase 1 DMC FDA Drug

• 1 other identifier: DV2-ZOS-02
• Study Type: interventional
• Target: 764
• Locations: 2 countries
• Sites: 16

Brief 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.

Conditions

Shingles; Herpes Zoster; Vaccine-Preventable Diseases

Outcome Measures

Primary Outcomes (5)

• 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)

  Up to 7 days following each dose

• Part 1 and Part 2: Percentage of participants with Adverse events (AEs)

  Adverse events (AEs)

  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)

  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

  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

  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

  4 weeks after the second study injection

• Part 1: Geometric mean ratio (GMR) of IgG antibodies to VZV antigen gE

  4 weeks after the second study injection

• Part 1: Geometric mean fold increase (GMFI) of IgG antibodies to VZV antigen gE

  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

  4 weeks after the second study injection

• Part 2: VRR for gE-specific CD4+ T cells

  4 weeks after second study injection

Study Arms (11)

Z-1018 A1 (Part 1)

EXPERIMENTAL

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

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.

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.

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.

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

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

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.

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.

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.

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.

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.

Biological: Shingrix

Interventions

Z-1018 BIOLOGICAL

Formulation for injection

Z-1018 A1 (Part 1); Z-1018 A2 (Part 1); Z-1018 B1(a) (Part 1); Z-1018 B1(b) (Part 1); Z-1018 B2(a) (Part 1 and Part 2); Z-1018 B2(b) (Part 1); Z-1018 Formulation C1(a) (Part 1); Z-1018 Formulation C1(b) (Part 1); Z-1018 Formulation C2(a) (Part 1); Z-1018 Formulation C2(b) (Part 1)

Shingrix BIOLOGICAL

Formulation for injection

Shingrix (Part 1 and Part 2)

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• History of sensitivity to any component of the trial vaccines
• 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
• 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
• 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)

Sponsors & Collaborators

• Dynavax Technologies Corporation: lead

Study Sites (16)

Paratus Clinical Research Western Syndney

Blacktown, New South Wales, 2148, Australia

Location

Emeritus Research

Botany, New South Wales, 2019, Australia

Location

Canopy Clinical Northern Beaches

Brookvale, New South Wales, 2100, Australia

Location

Paratus Clinical Research Central Coast

Kanwal, New South Wales, 2259, Australia

Location

Sutherland Shire Clinical Research

Miranda, New South Wales, 2228, Australia

Location

Innovate Clinical Research

Waitara, New South Wales, 2077, Australia

Location

Canopy Clinical Wollongong

Wollongong, New South Wales, 2500, Australia

Location

Paratus Clinical Research Brisbane

Herston, Queensland, 4006, Australia

Location

Veritus Research

Bayswater, Victoria, 3153, Australia

Location

Emeritus Research

Camberwell, Victoria, 3124, Australia

Location

Doherty Clinical Trials Limited

East Melbourne, Victoria, 3002, Australia

Location

Optimal Clinical Trials Ltd - North

Auckland, 0632, New Zealand

Location

Optimal Clinical Trials Ltd - Central

Auckland, 1010, New Zealand

Location

New Zealand Clinical Research

Christchurch, 8011, New Zealand

Location

Momentum Wellington

Wellington, 0621, New Zealand

Location

Momentum Clinical Research Kapiti

Wellington, 5036, New Zealand

Location

MeSH Terms

Conditions

Herpes Zoster; Vaccine-Preventable Diseases

Condition Hierarchy (Ancestors)

Varicella Zoster Virus Infection; Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• Robert Janssen, MD

  Dynavax Technologies Corporation

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2024
• First Posted: August 26, 2024
• Study Start: June 17, 2024
• Primary Completion (Estimated): November 1, 2027
• Study Completion (Estimated): November 1, 2031
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (11); NZ (5)