American Society of Hematology, Blood, 19(124), p. 2921-2929, 2014
DOI: 10.1182/blood-2014-04-573048
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Recombinant herpes zoster (HZ) vaccines may be an alternative to the live-attenuated HZ vaccine for immunocompromised individuals.This was a phase 1/2, randomized, observer-blind, placebo-controlled study in adults with multiple myeloma, non-Hodgkin lymphoma (B- or T-cell), Hodgkin lymphoma, or acute myeloid leukemia who had undergone autologous hematopoietic stem-cell transplant 50-70 days earlier. Subjects (N=121) were randomized 1:1:1:1 to receive (at months 0, 1, 3) three doses of 50 µg VZV glycoprotein E (gE) adjuvanted with AS01B, three doses of gE adjuvanted with AS01E, one dose of saline followed by two doses of gE/AS01B, or three doses of saline. One month after the last dose (6 months after transplant), frequencies of CD4(+) T cells expressing ≥2 activation markers following induction with gE and anti-gE antibody concentrations were higher with all gE/AS01 regimens than with saline. Both responses persisted up to one year in subjects vaccinated with gE/AS01. Immune responses were higher in the gE/AS01B 3-dose group than in the gE/AS01B 2-dose group but not higher than in the gE/AS01E 3-dose group. One serious adverse event (pneumonia) was considered vaccine-related. Both formulations and both schedules were immunogenic and well tolerated in this population. This study was registered at Clinicaltrials.gov as #NCT00920218.