Clinical trial NCT05245838: Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Shingles
Herpes Zoster
Vaccine-Preventable Diseases
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2022-02-18
Enrollment: 150
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: PREVENTION

Brief 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).


Eligibility criteria: 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

Primary outcomes:
measure: Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine
timeFrame: Day 1 to day 7
measure: Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine.
timeFrame: Day 57 to day 63
measure: Number of AEs (Adverse Events)
timeFrame: Day 1 through week 20
measure: Number of SAEs (Serious Adverse Events)
timeFrame: Through week 20
Secondary outcomes:
measure: Frequency of CD4+ T cells
timeFrame: At week 12
measure: Measure Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE)
timeFrame: At week 12
measure: Response rate of vaccine
timeFrame: At week 12
Other outcomes:
Locations:
city: Blacktown
country: Australia
facility: Paratus Clinical Research Western Sydney
state: New South Wales
city: Brookvale
country: Australia
facility: Northern Beaches Clinical Research
state: New South Wales
city: Kanwal
country: Australia
facility: Paratus Clinical Research Central Coast
state: New South Wales
city: Camberwell
country: Australia
facility: Emeritus Research Melbourne
state: Victoria
Study officials:
affiliation: Dynavax Technologies Corporation
name: Robert Janssen, MD
role: STUDY_CHAIR
References: