Status:
COMPLETED
Trial to Evaluate the Safety, Tolerability, and Immunogenicity of an Investigational Herpes Zoster Vaccine (Z-1018) Compared to Shingrix® in Healthy Adult Volunteers
Lead Sponsor:
Dynavax Technologies Corporation
Conditions:
Shingles
Herpes Zoster
Eligibility:
All Genders
50-69 years
Phase:
PHASE1
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- (g...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
January 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 20 2022
Estimated Enrollment :
150 Patients enrolled
Trial Details
Trial ID
NCT05245838
Start Date
January 10 2022
End Date
October 20 2022
Last Update
November 7 2022
Active Locations (4)
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1
Paratus Clinical Research Western Sydney
Blacktown, New South Wales, Australia, 2148
2
Northern Beaches Clinical Research
Brookvale, New South Wales, Australia, 2100
3
Paratus Clinical Research Central Coast
Kanwal, New South Wales, Australia, 2259
4
Emeritus Research Melbourne
Camberwell, Victoria, Australia, 3124