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血液悪性腫瘍

免疫抑制・化学療法施行中または施行後の患者7

造血器腫瘍を有する18歳以上の成人を対象に、組換え帯状疱疹ワクチン(RZV)を筋肉内に2回接種し、安全性と免疫原性を評価した第Ⅲ相無作為化観察者盲検プラセボ対照多施設共同試験。7,25

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Timing of vaccination:

Ongoing/starting cancer therapy: ≥10 days before or after cancer treatment.
Completed cancer therapy course: ≥10 days to 6 months after full course.

*The second dose of vaccine/placebo administered 1 to 2 months after the first dose; **Visit 3 Month 2, contact Month 7, Visit 4 Month 13 are respectively 1, 6, 12 months post-Visit 2; †contact Month 7.

RZV, recombinant zoster vaccine; YOA, years of age.

帯状疱疹に対するワクチンの有効性：事後解析の結果より7

RZV Placebo VE*
95% CI
N

n

 Incidence per 1000 person years N

n

 Incidence per 1000 person years % LL UL

P

value
259 2 8.5 256 14 66.2 87.2 44.3 98.6 0.0021

*Includes all haematological malignancy subgroups.

mTVC: from 1 month post dose 2 until study end; subjects having received 2 doses of RZV.

CI, confidence interval; LL, lower limit; mTVC, modified total vaccine cohort; N, number of subjects included in each group; n, number of subjects reporting at least one event in each group; RZV, recombinant zoster vaccine; UL, upper limit; VE, vaccine efficacy.

事後解析の結果、18歳以上の免疫不全・低下患者集団における帯状疱疹に対するワクチンの有効性は87.2％であると示されました。7

液性免疫応答7

column-graph-depicting-the-anti-glycoprotein-e-antibody-geometric-mean-concentration-in-patients-with-haematological-malignancies-pre-and-post-vaccination-with-the-recombinant-zoster-vaccine-or-placebo.-one-month-post-vaccine-dose-2,-the-geometric-mean-concentration-was-13445.6-milli-international-units-per-millilitre-in-the-recombinant-zoster-vaccine-group-and-832.0-milli-international-units-per-millilitre-in-the-placebo-group.-across-all-timepoints-up-to-month-13-post-vaccination-the-proportion-of-participants-with-anti-glycoprotein-e-antibody-geometric-mean-concentration-point-estimates-was-higher-in-the-vaccine-group-than-in-the-placebo-group-

All participants, including subjects with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia.
GMC, geometric mean concentration; Mo, month; Pre, pre-vaccination; RZV, recombinant zoster vaccine.

細胞性免疫応答7

column-graph-depicting-the-c-d-4-plus-t-cell-frequency-of-glycoprotein-e-specific-c-d-4-plus-t-cells-in-patients-with-haematological-malignancies-pre-and-post-vaccination-with-the-recombinant-zoster-vaccine-or-placebo.-1-month-post-dose-2,-the-median-c-d-4-plus-t-cell-frequency-was-3081.9-in-the-vaccine-group-and-99.0-in-the-placebo-group.-up-to-13-months-post-completion-of-the-two-dose-vaccination-schedule-c-d-4-plus-t-cell-frequency-in-the-recombinant-zoster-vaccine-group-remained-more-than-15-fold-higher-compared-with-the-placebo-group-

All participants, including subjects with non-Hodgkin B-cell lymphoma and chronic lymphocytic leukaemia.
BCL, B-cell lymphoma; CLL, chronic lymphocytic leukaemia; IQR, interquartile range; Mo, month; RZV, recombinant zoster vaccine.

RZVワクチン接種後の免疫原性（液性および細胞性免疫応答）は、接種後13ヵ月目までベースラインを上回って持続した。7
細胞性免疫応答は年齢（18～49歳および50歳以上）に影響されなかったが、液性免疫応答は50歳以上と比較して若年層でわずかに強い傾向が観察された。7,18

Reactogenicity of RZV compared with placebo7

  RZV N=278 Placebo N=274
  n % n %
局所性特定有害事象
（　）内はグレード3a
  
注射部位疼痛
 221 (29) 79.5 (10.4) 45 (0) 16.4 (0.0)
注射部位発赤
 115 (12) 41.4 (4.3) 5 (0) 1.8 (0.0)
注射部位腫脹
 63 (5) 22.7 (1.8) 2 (0) 0.7 (0.0)
全身性特定有害事象
（　）内はグレード3		  
疲労
 162 (23) 58.3 (8.3) 102 (10) 37.2 (3.6)
胃腸症状 76 (9)
 27.3 (3.2) 29 (3) 10.6 (1.1)
頭痛 115 (12) 41.4 (4.3) 64 (6) 23.4 (2.2)
筋肉痛 122 (22) 43.9 (7.9) 48 (5) 17.5 (1.8)
悪寒 69 (11) 24.8 (4.0) 18 (0) 6.6 (0.0)
発熱 68 (3) 24.5 (1.1) 21 (1) 7.7 (0.4)

aグレード3の有害事象は、日常生活に支障をきたすもの（頭痛、疲労、胃腸症状、筋肉痛、悪寒）、安静時にかなりの痛みがあり日常生活に支障をきたすもの（注射部位の疼痛）、表面直径が100mmを超えるもの（注射部位の発赤および腫脹）、または体温が39.0℃を超える発熱と定義された。

安全性7

 

 RZV N=283 Placebo N=279
  n % n %
重篤な有害事象（SAE）
 66 23.3 82 29.4
ワクチン接種と関連ありのSAE（Related SAE）
 1 0.4 1 0.4
死亡に至るSAE（Fatal SAE）
 29 10.2 37 13.3
ワクチン接種と関連ありの死亡に至るSAE （Related fatal SAE）
 1* 0.4 0.0 0.0
Disease-related event† 45 15.9 58 20.8
免疫の関与が疑われる疾患（pIMDs）:
 3 1.1 2 0.7

自己免疫性溶血性貧血

 0 - 1 -

自己免疫性汎血球減少症

 1 - 0 -

痛風

 1 - 0 -

ギラン・バレー症候群

 0 - 1 -

結節性紅斑

 1 - 0 -

*Related SAEのうち1件は、さらにFatal SAEに分類され、治験責任医師によって、ワクチン接種と関連ありと判断された。この事象は、妊娠判明前にワクチン接種を受けた被験者の子供の新生児死亡であった。

†原疾患の造血器腫瘍の再発または進行。

自家造血幹細胞移植（auHSCT）患者におけるワクチンの試験概要・結果

血液悪性腫瘍患者におけるワクチンの試験概要・結果

固形腫瘍患者におけるワクチンの試験概要・結果

腎移植患者におけるワクチンの試験概要・結果

HIV感染症患者におけるワクチンの試験概要・結果

Abbreviations

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, recombinat zoster vaccine; SAE, serious adverse event; TVC, total vaccinated cohort; UL, upper limit; VE, vaccine efficacy; VRR, vaccine response rate; YOA, years of age

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, recombinat zoster vaccine; SAE, serious adverse event; TVC, total vaccinated cohort; UL, upper limit; VE, vaccine efficacy; VRR, vaccine response rate; YOA, years of age

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NX-JP-SGX-WCNT-230011 | November 2023