Actively Recruiting
Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over
Led by Dynavax Technologies Corporation · Updated on 2025-11-06
764
Participants Needed
13
Research Sites
384 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 764 healthy adults.
CONDITIONS
Official Title
Safety and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adults 50 Years of Age and Over
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Willing to participate and provide informed consent
- Male or female aged 50 years or older (Part 1: 50 through 69 years inclusive; Part 2: 70 years or older)
- In good health based on medical history, physical exam, and lab tests
- Able to understand and follow all study procedures and attend all scheduled visits
- Negative for HIV, hepatitis B, and hepatitis C at screening
- If female of child-bearing potential and sexually active, practicing effective contraception for at least 28 days before vaccination, has negative pregnancy tests before vaccination, and agrees to continue contraception for 3 months after the last study injection
You will not qualify if you...
- History of shingles (herpes zoster)
- Previous vaccination against chickenpox or shingles
- Fever (temperature ≥ 38°C) within 7 days before the first study injection
- Confirmed COVID-19 infection within 7 days before the first study injection
- Female participants who are pregnant, breastfeeding, or planning pregnancy or breastfeeding
- Known or suspected immune deficiency or immunocompromised state
- History of allergy to any vaccine component
- Receipt of certain vaccines, immunosuppressive drugs, or investigational agents within specified timeframes before Day 1
- Undergoing or expected to undergo chemotherapy; cancer diagnosis within last 5 years except certain skin cancers
- Any condition or treatment that could interfere with participation or immune response as judged by investigator
- Chronic medical conditions requiring ongoing monitoring that may affect vaccine response
- Psychiatric or substance abuse disorders interfering with study cooperation
- Current or past autoimmune disease
- Skin conditions or tattoos on both arms interfering with injection site safety assessment
- Any other factor making participant unsuitable or unable to comply with study requirements
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 13 locations
1
Emeritus Research
Botany, New South Wales, Australia, 2019
Actively Recruiting
2
Canopy Clinical Northern Beaches
Brookvale, New South Wales, Australia, 2100
Actively Recruiting
3
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia, 2259
Actively Recruiting
4
Sutherland Shire Clinical Research
Miranda, New South Wales, Australia, 2228
Actively Recruiting
5
Innovate Clinical Research
Waitara, New South Wales, Australia, 2077
Actively Recruiting
6
Canopy Clinical Wollongong
Wollongong, New South Wales, Australia, 2500
Actively Recruiting
7
Paratus Clinical Research Brisbane
Herston, Queensland, Australia, 4006
Actively Recruiting
8
Momentum Clinical Research Wellers Hill
Tarragindi, Queensland, Australia, 4121
Actively Recruiting
9
Veritus Research
Bayswater, Victoria, Australia, 3153
Actively Recruiting
10
Emeritus Research
Camberwell, Victoria, Australia, 3124
Actively Recruiting
11
Optimal Clinical Trials Ltd - North
Auckland, New Zealand, 0632
Not Yet Recruiting
12
Optimal Clinical Trials Ltd - Central
Auckland, New Zealand, 1010
Not Yet Recruiting
13
Momentum Wellington
Wellington, New Zealand, 0621
Not Yet Recruiting
Research Team
O
Ouzama Henry, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
11
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