Skip to main content
OpenTrials
Completed

NCT Number: NCT05245838

Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers

This is a randomized, active-controlled, dose-escalation multi-center study of 2 doses (Day 1 and Week 8) of an investigational herpes zoster (HZ) vaccine (Z-1018), combining herpes zoster antigen- (gE) with a Toll-like receptor 9 (TLR9) agonist adjuvant (CpG 1018) with and without alum in approximately 150 healthy volunteers 50 to 69 years of age (inclusive).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Shingles DNA Virus Infections Herpes Zoster Herpesviridae Infections Infections Vaccine-Preventable Diseases Varicella Zoster Virus Infection Virus Diseases

Age range

50 year–69 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Paratus Clinical Research Western Sydney, Blacktown, New South Wales, Australia

Loading trial locations.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Male or female, 50 to 69 years of age
  • Be in good health in the opinion of the investigator, based upon medical history, physical examination, and laboratory evaluation
  • Must be able to comprehend and follow all required study procedures and be available for all visits scheduled in the study
  • Seronegative for human immunodeficiency virus (HIV)

Exclusion criteria

  • History of HZ
  • Previous vaccination against varicella or HZ
  • If female of childbearing potential, is pregnant, breastfeeding, or planning a pregnancy
  • Known history of HIV (HIV 1/2 antibodies)
  • Has a history of sensitivity to any component of study vaccines
  • 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
  • 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
  • Chronic administration of immunosuppressants or other immune-modifying drugs within 6 months prior to the first vaccine dose
  • 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
  • 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
  • History of autoimmune disease

Treatment and study plan

Z-1018

Biological

contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 3000 mcg

Shingrix

Biological

a suspension for injection supplied as a single-dose vial of 50 mcg varicella zoster virus (VZV) glycoprotein E (gE) antigen and AS01B adjuvant

Primary outcomes

  1. Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine

    Time frame: Day 1 to day 7

  2. Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine.

    Time frame: Day 57 to day 63

  3. Number of AEs (Adverse Events)

    Time frame: Day 1 through week 20

  4. Number of SAEs (Serious Adverse Events)

    Time frame: Through week 20

Secondary outcomes

  1. Frequency of CD4+ T cells

    Time frame: At week 12

  2. Measure Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE)

    Time frame: At week 12

  3. Response rate of vaccine

    Time frame: At week 12

Sponsors and collaborators

Lead sponsor

Dynavax Technologies Corporation

Industry

Registry information

Official study title

A Phase 1 Randomized, Subject-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 Volunteers Between the Ages of 50 and 69 Years

Important dates

Study start
2022
Primary completion
2022
Study completion
2022
First posted
Feb 18, 2022
Registry last updated
Nov 7, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.