Herpes Zoster, Shingles, Vaccine-Preventable Diseases
Conditions
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).
Interventions
BIOLOGICALZ-1018
contains gE at a dose of 100 mcg to be combined with a Toll-like receptor 9 agonist adjuvant, CpG 1018 at dose of 3000 mcg
BIOLOGICALShingrix
a suspension for injection supplied as a single-dose vial of 50 mcg varicella zoster virus (VZV) glycoprotein E (gE) antigen and AS01B adjuvant
Sponsors
Dynavax Technologies Corporation
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
PREVENTION
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
50 Years to 69 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine | Day 1 to day 7 |
| Frequency of solicited local and systemic post-injection reactions (PIRs) 7 days after administration of study vaccine. | Day 57 to day 63 |
| Number of AEs (Adverse Events) | Day 1 through week 20 |
| Number of SAEs (Serious Adverse Events) | Through week 20 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Frequency of CD4+ T cells | At week 12 |
Countries
Australia
Outcome results
None listed