Skip to content





Visit 3: approximately 1 month after the second vaccination.
*Second dose was administered 1 to 2 months after the first dose.
Blood sampling collected from all subjects at Visit 1 and Visit 3. Additional blood samples collected from sub-cohorts at all study visits.

auHSCT, autologous haematopoietic stem cell transplant; RZV, recombinant zoster vaccine; TVC, total vaccinated cohort; YOA, years of age.




N (n)


N (n)




VE by Age          
18–49 213 (9) 212 (29) 71.8 38.8 88.3
≥50 657 (40) 639 (106) 67.3 52.6 77.9
Other HZ-related endpoints  

870 (1) 851 (9) 89.3 22.5 99.8
HZ-related hospitalisations 870 (2) 851 (13) 84.7 32.1 96.6
Other HZ complications* 870 (3) 851 (13) 77.8 19.0 95.9

*Excluding PHN: disseminated zoster: 3 (recombinant zoster vaccine group) and 13 (placebo group); meningoencephalitis: 1 (placebo group); whole study period, median follow-up time approximately 21 months.

HZ, herpes zoster; LL, lower limit; N, number of subjects included in each group; n, number of subjects having at least one confirmed HZ episode; PHN, post-herpetic neuralgia; RZV, recombinant zoster vaccine; UL, upper limit; VE, vaccine efficacy.



column-graph-showing-anti–glycoprotein-e-geometric-mean-concentrations-in-autologous-haematopoietic-stem-cell transplantation-patients-prior-to-and-after-vaccination-with-either-the-recombinant-zoster-vaccine-or-placebo.-highest-anti–glycoprotein-e-geometric-mean-concentrations-were-recorded-one-month-after-dose-two,-which-remained-above-baseline-24-months-after-completion-of-the-vaccination-schedule-

gE, glycoprotein E; GMC, geometric mean concentration; Mo, month; RZV, recombinant zoster vaccine.
Graph based on raw data from the Clinical Trial NCT01610414.23



gE, glycoprotein E; IQR, interquartile range; Mo, month; RZV, recombinant zoster vaccine.
Figure based on raw data from Bastidas A, et al. JAMA. 2019;322(2):123–133.5,23


column-graphs-depicting-local-and-general-reactions-in-autologous-haematopoietic-stem-cell transplantation-patients-who-received-either-the-recombinant-zoster-vaccine-or-placebo.-local-and-general-reactions-were-more-frequently-reported-by-those-in-the-vaccine-group-compared-with-the-placebo-group.-in-patients-who-received-the-recombinant-zoster-vaccine,-the-most-frequently-reported-local-adverse-reaction-was-pain-at-the-injection-site;-fatigue,-myalgia-and-headache-were-the-most-frequently-reported-general-reactions-

Any symptom, occurrence of the symptom regardless of intensity grade; Grade 3 pain, pain that prevented normal activity; Grade 3 redness/swelling, redness/swelling spreading beyond 100 mm of injection site; Grade 3 symptom, symptom that prevented normal activity; fever defined as a temperature (preferably oral) ≥37.5°C; Grade 3 fever >39.0°C.

GI, gastrointestinal (nausea, vomiting, diarrhoea and abdominal pain); RZV, recombinant zoster vaccine.

Figure based on raw data from Bastidas A, et al. JAMA. 2019;322(2):123-133.

最も頻度が高かった局所および全身性の有害事象 (AE) は、接種部位の疼痛、疲労、筋肉痛でした。5


An unsolicited AE covers any untoward medical occurrence in a clinical investigation subject temporally associated with the use of a medicinal product, whether or not considered related to the medicinal product and reported in addition to those solicited during the clinical study and any solicited symptom with onset outside the specified period of follow-up for solicited symptoms.
Grade 3, severe AE that prevents normal activity.

AE, adverse event; auHSCT, autologous haematopoietic stem cell transplant; pIMD, potential immune-mediated disease; RZV, recombinant zoster vaccine; SAE, serious adverse event.

Figure based on raw data from Bastidas A, et al. JAMA. 2019;322(2):123–133.



AE, adverse event; ART, anti-retroviral therapy; ATP, according to protocol; BCL, B-cell lymphoma; CLL, chronic lymphocytic leukaemia; CMI, cell-mediated immunity; gE, glycoprotein E; GI, gastrointestinal; GMC, geometric mean concentration; HIV, human immunodeficiency virus; IQR, interquartile range; LL, lower limit; Mo, month; mTVC, modified total vaccinated cohort; pIMD, potential immune-mediated disease; PHN, post-herpetic neuralgia; Pre, pre-vaccination; Q, quartile; RZV, recombinant zoster virus; SAE, serious adverse event; TVC, total vaccinated cohort; UL, upper limit; VE, vaccine efficacy; VRR, vaccine response rate; YOA, years of age


  1. Chen SY, et al. Infection. 2014;42(2):325–334
  2. Zhang D, et al. Adv Ther. 2017;34(7):1610–1621.
  3. Sahoo F, et al. Biol Blood Marrow Transplant. 2017;23(3):505–511.
  4. Winston DJ, et al. Lancet. 2018;391(10135):2116–2127
  5. Bastidas A, et al. JAMA. 2019;322(2):123–133
  6. Habel LA, et al. Cancer Epidemiol Biomarkers Prev. 2013;22(1):82–90
  7. Dagnew AF, et al. Lancet Infect Dis. 2019;19(9):988–1000
  8. Koo S, et al. Transpl Infect Dis. 2014;16(1):17–25
  9. Pergam SA, et al. Transpl Infect Dis. 2011;13(1):15–23
  10. Arness T, et al. Transpl Infect Dis. 2008;10(4):260–268
  11. Mao J, et al. Medicine (Baltimore). 2017;96(48):e8746
  12. Tseng HF, et al. Clin Infect Dis. 2014;59(7):913–919
  13. Blank LJ, et al. J Acquir Immune Defic Syndr. 2012;61(2):203–207
  14. Chakravarty EF. Rheum Dis Clin North Am. 2017;43(1):111–121
  15. Veetil BM, et al. Arthritis Care Res (Hoboken). 2013;65(6):854–861
  16. Khan N, et al. Clin Gastroenterol Hepatol. 2018;16(12):1919–1927
  17. Johnson BH, et al. BMC Infect Dis. 2015;15:502
  18. Dagnew AF, et al. Hum Vaccin Immunother. 2021;17(11):4132–4143
  19. Berkowitz EM, et al. J Infect Dis. 2015;211(8):1279–1287
  20. Vink P, et al. Clin Infect Dis. 2020;70(2):181–190
  21. Vink P, et al. Cancer. 2019;125(8):1301–1312
  22. de la Serna J, et al. Efficacy and Safety of an Adjuvanted Herpes Zoster Subunit Vaccine in Autologous Hematopoietic Stem Cell Transplant Recipients 18 Years of Age or Older: First Results of the Phase 3 Randomized, Placebo-Controlled ZOE-HSCT Clinical Trial. Presented at BMT Tandem Meeting; 25th February 2018; Salt Lake City, UT, USA.
  23. NCT01610414. Available at: (accessed May 2023).
  24. Zoster-002 Clinical Study Report 115523. Available at: (accessed May 2023).
  25. Zoster-039 Clinical Study Report 116428. Available at: (accessed May 2023)
  26. NCT01798056. Available at: (accessed May 2023).
  27. Zoster-028 Clinical Study Report 116427. Available at: (accessed May 2023).
  28. Vink P. Immunogenicity and Safety of a Candidate Subunit Adjuvanted Herpes Zoster Vaccine in Adults with Solid Tumors Vaccinated Before or During Immunosuppressive Chemotherapy Treatment: A Phase II/III, Randomized Clinical Trial. Poster #1349. Presented at IDWeek; 4–8 October, 2017; San Diego, CA, USA.
  29. NCT02058589. Available at: (accessed May 2023).
  30. Vink P, et al. Open Forum Infect Dis. 2018;5(suppl 1):S744–S745
  31. Zoster-041 Clinical Study Report 116886. Available at: (accessed May 2023).
  32. Zoster-015 Clinical Study Report 112673. Available at: (accessed May 2023).

NX-JP-SGX-WCNT-230009 | October 2023