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A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients.

Publication ,  Journal Article
Stadtmauer, EA; Sullivan, KM; Marty, FM; Dadwal, SS; Papanicolaou, GA; Shea, TC; Mossad, SB; Andreadis, C; Young, J-AH; Buadi, FK; Heineman, TC ...
Published in: Blood
November 6, 2014

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.

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Published In

Blood

DOI

EISSN

1528-0020

Publication Date

November 6, 2014

Volume

124

Issue

19

Start / End Page

2921 / 2929

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Transplantation, Autologous
  • Multiple Myeloma
  • Middle Aged
  • Male
  • Lymphoma, Non-Hodgkin
  • Leukemia, Myeloid, Acute
  • Immunology
  • Humans
 

Citation

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Stadtmauer, E. A., Sullivan, K. M., Marty, F. M., Dadwal, S. S., Papanicolaou, G. A., Shea, T. C., … Berkowitz, E. M. (2014). A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. Blood, 124(19), 2921–2929. https://doi.org/10.1182/blood-2014-04-573048
Stadtmauer, Edward A., Keith M. Sullivan, Francisco M. Marty, Sanjeet S. Dadwal, Genovefa A. Papanicolaou, Thomas C. Shea, Sherif B. Mossad, et al. “A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients.Blood 124, no. 19 (November 6, 2014): 2921–29. https://doi.org/10.1182/blood-2014-04-573048.
Stadtmauer EA, Sullivan KM, Marty FM, Dadwal SS, Papanicolaou GA, Shea TC, et al. A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. Blood. 2014 Nov 6;124(19):2921–9.
Stadtmauer, Edward A., et al. “A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients.Blood, vol. 124, no. 19, Nov. 2014, pp. 2921–29. Pubmed, doi:10.1182/blood-2014-04-573048.
Stadtmauer EA, Sullivan KM, Marty FM, Dadwal SS, Papanicolaou GA, Shea TC, Mossad SB, Andreadis C, Young J-AH, Buadi FK, El Idrissi M, Heineman TC, Berkowitz EM. A phase 1/2 study of an adjuvanted varicella-zoster virus subunit vaccine in autologous hematopoietic cell transplant recipients. Blood. 2014 Nov 6;124(19):2921–2929.

Published In

Blood

DOI

EISSN

1528-0020

Publication Date

November 6, 2014

Volume

124

Issue

19

Start / End Page

2921 / 2929

Location

United States

Related Subject Headings

  • Young Adult
  • Treatment Outcome
  • Transplantation, Autologous
  • Multiple Myeloma
  • Middle Aged
  • Male
  • Lymphoma, Non-Hodgkin
  • Leukemia, Myeloid, Acute
  • Immunology
  • Humans