Clinical trial NCT06569823: Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults
Official title: A Phase 1/2 Randomized, Observer-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 Adults
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
PHASE2
Conditions: Shingles
Herpes Zoster
Vaccine-Preventable Diseases
Lead sponsor: Dynavax Technologies Corporation
Sponsor class: INDUSTRY
First posted: 2024-08-26
Enrollment: 440
Sex: ALL
Minimum age (years): 50
Maximum age (years): 69
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.


Eligibility criteria: 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

Primary outcomes:
measure: Percentage of participants with solicited local and systemic post-injection reactions (PIRs)
timeFrame: Up to 7 days following each dose
measure: Percentage of participants with Adverse events (AEs)
timeFrame: 28 days following each dose
measure: Percentage of participants with serious adverse events (SAEs), medically-attended adverse events (MAEs), and immune-mediated adverse events of special interest (imAESIs)
timeFrame: Day 1 through 12 months after the last dose of study injection
Secondary outcomes:
measure: Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE) 4 weeks after the second study injection
timeFrame: 4 weeks after the second study injection
measure: Geometric mean ratio (GMR) of IgG antibodies to VZV antigen gE
timeFrame: 4 weeks after the second study injection
measure: Geometric mean fold increase (GMFI) of IgG antibodies to VZV antigen gE
timeFrame: 4 weeks after the second study injection
measure: Vaccine response rate (VRR) for anti-gE IgG antibodies to VZV antigen gE
timeFrame: 4 weeks after the second study injection
Other outcomes:
Locations:
city: Brookvale
country: Australia
facility: Northern Beaches Clinical Research
state: New South Wales
Study officials:
affiliation: Dynavax Technologies Corporation
name: Robert Janssen, MD
role: STUDY_CHAIR
References: