Download A phase 1/2 study of an adjuvanted varicella-zoster virus - E

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Phase 1/2a
Study Design I
Edward A. Stadtmauer et al. Blood 2014;124:2921-2929
 Observer blind – Randomized – Placebo controlled
N = 121 pts
 121 pts were randomized - 1:1:1:1 – 1 pt not vaccinated
 Taking into account underlying disease
Patient Characteristics
MM or B/T cell NHL or HL or AML
Autologous HCT in the previous 50-70 days
Women of non-child-bearing potential
Exclusion Criteria
Previous VZV/HZ vaccination
Hx of VZV infection within the previous 12 months
Exposure to VZV post HCTx
Immunoglobulin Rx or vaccination post HCTx
Acute infection upon enrollment
Contraindication to vaccination (ie allergies)
Receiving any investigational product 30 days ago – throughout the whole study