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

Edward A. Stadtmauer, Keith M. Sullivan, Francisco M. Marty, Sanjeet S. Dadwal, Genovefa A. Papanicoleau, Thomas C. Shea, Sherif B. Mossad, Charalambos Andreadis, Jo-Anne H. Young, Francis K. Buadi, Mohamed El Idrissi, Thomas C. Heineman and Elchonon M. Berkowitz

Key points

  • HCT recipients have increased susceptibility to herpes zoster but live-attenuated vaccines are not appropriate for highly immunocompromised people.

  • An adjuvanted subunit vaccine against herpes zoster elicits strong immune response and acceptable safety profile in autologous HCT recipients.


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 as #NCT00920218.

  • Submitted April 30, 2014.
  • Accepted September 1, 2014.