title: A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients.
abstract: 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 to 70 days earlier. Subjects (N = 121) were randomized 1:1:1:1 to receive (at months 0, 1, 3) three doses of 50 μg varicella-zoster virus glycoprotein E (gE) adjuvanted with AS01B, 3 doses of gE adjuvanted with AS01E, 1 dose of saline followed by 2 doses of gE/AS01B, or 3 doses of saline. One month after the last dose (6 months after transplant), frequencies of CD4(+) T cells expressing ≥2 activation markers after induction with gE and anti-gE antibody concentrations were higher with all gE/AS01 regimens than with saline. Both responses persisted up to 1 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 www.clinicaltrials.gov as #NCT00920218.
authors.affiliation: University of Pennsylvania, Perelman School of Medicine, Philadelphia, PA;
authors.forename: Edward A
authors.initials: EA
authors.lastname: Stadtmauer
authors.affiliation: Duke University Medical Center, Durham, NC;
authors.forename: Keith M
authors.initials: KM
authors.lastname: Sullivan
authors.affiliation: Dana-Farber Cancer Institute and Brigham & Women's Hospital, Boston, MA;
authors.forename: Francisco M
authors.initials: FM
authors.lastname: Marty
authors.affiliation: City of Hope, Duarte, CA;
authors.forename: Sanjeet S
authors.initials: SS
authors.lastname: Dadwal
authors.affiliation: Memorial Sloan-Kettering Cancer Center, New York, NY;
authors.forename: Genovefa A
authors.initials: GA
authors.lastname: Papanicolaou
authors.affiliation: University of North Carolina Hospital, Chapel Hill, NC;
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Shea
authors.affiliation: Cleveland Clinic Foundation, Cleveland, OH;
authors.forename: Sherif B
authors.initials: SB
authors.lastname: Mossad
authors.affiliation: University of California Medical Center, San Francisco, CA;
authors.forename: Charalambos
authors.initials: C
authors.lastname: Andreadis
authors.affiliation: University of Minnesota, Minneapolis, MN;
authors.forename: Jo-Anne H
authors.initials: JA
authors.lastname: Young
authors.affiliation: Mayo Clinic, Rochester, MN;
authors.forename: Francis K
authors.initials: FK
authors.lastname: Buadi
authors.affiliation: GlaxoSmithKline Vaccines, Wavre, Belgium; and.
authors.forename: Mohamed
authors.initials: M
authors.lastname: El Idrissi
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, PA.
authors.forename: Thomas C
authors.initials: TC
authors.lastname: Heineman
authors.affiliation: GlaxoSmithKline Vaccines, King of Prussia, PA.
authors.forename: Elchonon M
authors.initials: EM
authors.lastname: Berkowitz
mesh_terms: D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D019337:Hematologic Neoplasms / Q000276:immunology / Q000628:therapy*; D018380:Hematopoietic Stem Cell Transplantation / Q000379:methods*; D053061:Herpes Zoster Vaccine / Q000276:immunology / Q000627:therapeutic use*; D014645:Herpesvirus 3, Human / Q000276:immunology*; D006689:Hodgkin Disease / Q000276:immunology / Q000628:therapy; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000276:immunology / Q000628:therapy; D008228:Lymphoma, Non-Hodgkin / Q000276:immunology / Q000628:therapy; D008297:Male; D008875:Middle Aged; D009101:Multiple Myeloma / Q000276:immunology / Q000628:therapy; D014182:Transplantation, Autologous; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D053061:Herpes Zoster Vaccine