A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients Journal Article
| Authors: | Stadtmauer, E. A.; Sullivan, K. M.; Marty, F. M.; Dadwal, S. S.; Papanicolaou, G. A.; Shea, T. C.; Mossad, S. B.; Andreadis, C.; Young, J. A. H.; Buadi, F. K.; Idrissi, M. E.; Heineman, T. C.; Berkowitz, E. M. |
| Article 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 leukemiawhohad 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 mg 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 ≥ 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. |
| Keywords: | adult; controlled study; protein expression; aged; acute granulocytic leukemia; major clinical study; lenalidomide; drug tolerability; fatigue; placebo; diarrhea; drug efficacy; drug safety; side effect; cancer patient; biological marker; multiple myeloma; phase 2 clinical trial; gastrointestinal symptom; nausea; randomized controlled trial; vomiting; myalgia; herpes zoster; hodgkin disease; abdominal pain; fever; injection site reaction; pneumonia; drug induced headache; b cell lymphoma; myeloablative conditioning; nonhodgkin lymphoma; nonmyeloablative conditioning; cellular immunity; immunogenicity; cd4+ t lymphocyte; injection site pain; phase 1 clinical trial; humoral immunity; plerixafor; sodium chloride; graft recipient; autologous hematopoietic stem cell transplantation; zoledronic acid; drug formulation; virus immunity; immunization; varicella zoster vaccine; subunit vaccine; single blind procedure; adjuvant; injection site swelling; human; male; female; article; glycoprotein e |
| Journal Title: | Blood |
| Volume: | 124 |
| Issue: | 19 |
| ISSN: | 0006-4971 |
| Publisher: | American Society of Hematology |
| Date Published: | 2014-11-06 |
| Start Page: | 2921 |
| End Page: | 2929 |
| Language: | English |
| DOI: | 10.1182/blood-2014-04-573048 |
| PROVIDER: | scopus |
| PUBMED: | 25237196 |
| PMCID: | PMC4327150 |
| DOI/URL: | |
| Notes: | Export Date: 1 December 2014 -- Source: Scopus |
