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

NCT05245838
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Participants
150
clinicaltrials.gov
Lead sponsor
Dynavax Technologies Corporation
clinicaltrials.gov
Start date
2022-01-10
clinicaltrials.gov
Number of sites
4
clinicaltrials.gov

Summary
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).
clinicaltrials.gov
Short title
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers
clinicaltrials.gov
Official 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
clinicaltrials.gov

Control arm
Active comparator
clinicaltrials.gov
Registry reports results
No
clinicaltrials.gov
Listing at source
Listed
clinicaltrials.gov
Recruitment status
Completed
clinicaltrials.gov
Phase
Phase 1
clinicaltrials.gov
Study type
Interventional
clinicaltrials.gov

Completion date
2022-10-20
clinicaltrials.gov
First posted
2022-02-18
clinicaltrials.gov
Registry last updated
2022-11-07
clinicaltrials.gov
Primary completion date
2022-10-20
clinicaltrials.gov
Start date
2022-01-10
clinicaltrials.gov

Actual participants
150
clinicaltrials.gov
Participants
150
clinicaltrials.gov
Participant count basis
Actual
clinicaltrials.gov
Protocol amendments
1
clinicaltrials.gov
Number of sites
4
clinicaltrials.gov

Data monitoring committee
Yes
clinicaltrials.gov
Registry sponsor category
Industry
clinicaltrials.gov
Lead sponsor
Dynavax Technologies Corporation
clinicaltrials.gov
Source registry
ClinicalTrials.gov
clinicaltrials.gov

Registry ID
NCT05245838
clinicaltrials.gov
ClinicalTrials.gov ID
NCT05245838
clinicaltrials.gov
Registry record
Open registry record
clinicaltrials.gov

Allocation
Randomised
Model
Sequential
Purpose
Prevention
Masking
Single masking
Masked roles
Participants
Sources for study design
clinicaltrials.gov

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

    Timeframe: Day 1 to day 7

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

    Timeframe: Day 57 to day 63

  3. Number of AEs (Adverse Events)

    Timeframe: Day 1 through week 20

  4. Number of SAEs (Serious Adverse Events)

    Timeframe: Through week 20

  1. Frequency of CD4+ T cells

    Timeframe: At week 12

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

    Timeframe: At week 12

  3. Response rate of vaccine

    Timeframe: At week 12

Sources for outcomes
clinicaltrials.gov

Sex
All
Age groups
Adults, Older adults
Minimum age
50 Years
Maximum age
69 Years
Healthy volunteers
Yes

  • 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)

  • 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

Sources for eligibility
clinicaltrials.gov

  • Paratus Clinical Research Western SydneyBlacktown, Australia
  • Northern Beaches Clinical ResearchBrookvale, Australia
  • Paratus Clinical Research Central CoastKanwal, Australia
  • Emeritus Research MelbourneCamberwell, Australia
Sources for sites
clinicaltrials.gov

Sources for references
clinicaltrials.gov

Related records

Drugs (1)

Lead sponsors (1)

Conditions (1)