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

Phase 1

Recruiting

• Conditions: Shingles; Vaccine-Preventable Diseases; Herpes Zoster
• Interventions: Biological: Z-1018; Biological: Shingrix

• Registration Number: NCT06569823
• Lead Sponsor: Dynavax Technologies Corporation

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 440 healthy adults.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-17
• Study First Submitted: 2024-07-08
• Status Verified: 2024-08
• Study First Submitted QC: 2024-08-22
• Last Update Submitted: 2024-08-22
• Study First Posted: 2024-08-26
• Last Update Posted: 2024-08-26
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 440

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)

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Z-1018 Formulation C1(b)	Z-1018	Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85.
Z-1018 A1	Z-1018	Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85.
Z-1018 A2	Z-1018	Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85.
Z-1018 B1(a)	Z-1018	Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57.
Z-1018 B2(a)	Z-1018	Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57.
Z-1018 B1(b)	Z-1018	Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85
Z-1018 B2(b)	Z-1018	Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85
Z-1018 Formulation C2(a)	Z-1018	Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57.
Z-1018 Formulation C1(a)	Z-1018	Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 57.
Z-1018 Formulation C2(b)	Z-1018	Participants will receive a dose of Z-1018 by intramuscular (IM) injection on Day 1 and Day 85.
Shingrix	Shingrix	Participants will receive a dose of Shingrix by intramuscular (IM) injection on Day 1 and Day 57, or Day 1 and Day 85.

Primary Outcome Measures

Name	Time	Method
Percentage of participants with solicited local and systemic post-injection reactions (PIRs)	Up to 7 days following each dose	Solicited local and systemic post-injection reactions (PIRs)
Percentage of participants with Adverse events (AEs)	28 days following each dose	Adverse events (AEs)
Percentage of participants with serious adverse events (SAEs), medically-attended adverse events (MAEs), and immune-mediated adverse events of special interest (imAESIs)	Day 1 through 12 months after the last dose of study injection	Serious adverse events (SAEs) Medically-attended adverse events (MAEs) Immune-mediated adverse events of special interest (imAESIs)

Secondary Outcome Measures

Name	Time	Method
Geometric mean fold increase (GMFI) of IgG antibodies to VZV antigen gE	4 weeks after the second study injection	Geometric mean fold increase (GMFI) of IgG antibodies to VZV antigen gE in the Per Protocol (PP) population
Vaccine response rate (VRR) for anti-gE IgG antibodies to VZV antigen gE	4 weeks after the second study injection	Vaccine response rate (VRR) for anti-gE IgG antibodies to VZV antigen gE in the Per Protocol (PP) population
Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE) 4 weeks after the second study injection	4 weeks after the second study injection	Geometric mean concentration (GMC) to varicella-zoster virus (VZV) gE in the Per Protocol (PP) population
Geometric mean ratio (GMR) of IgG antibodies to VZV antigen gE	4 weeks after the second study injection	Geometric mean ratio (GMR) of IgG antibodies to VZV antigen gE in the Per Protocol (PP) population

Trial Locations

Locations (1)

Northern Beaches Clinical Research; 🇦🇺 Brookvale, New South Wales, Australia