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
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Shingles
- Sponsor
- Dynavax Technologies Corporation
- Enrollment
- 150
- Locations
- 4
- Primary Endpoint
- Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine
- Status
- Completed
- Last Updated
- 3 years ago
Overview
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).
Investigators
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
- •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
Outcomes
Primary Outcomes
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine
Time Frame: Day 1 to day 7
Number of SAEs (Serious Adverse Events)
Time Frame: Through week 20
Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine.
Time Frame: Day 57 to day 63
Number of AEs (Adverse Events)
Time Frame: Day 1 through week 20
Secondary Outcomes
- Frequency of CD4+ T cells(At week 12)
- Measure Geometric mean concentration (GMC) of IgG antibodies to varicella-zoster virus (VZV) antigen glycoprotein E (gE)(At week 12)
- Response rate of vaccine(At week 12)