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腎移植患者

腎移植後の患者20

腎移植を受けた18歳以上の成人を対象に、組換え帯状疱疹ワクチン(RZV)を1～2ヶ月間隔で2回筋肉内投与し、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。20,29-31

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試験デザイン20,31

study-design-to-assess-the-immunogenicity-and-safety-of-the-recombinant-zoster-vaccine-when-administered-intramuscularly-on-a-0-and-1-to-two-month-schedule-to-adults-18-years-of-age-and-older-with-renal-transplants.-participants-were-randomised-one-to-one-to-receive-two-doses-of-either-the-recombinant-zoster-vaccine-or-placebo-one-to-two-months-apart.-visits-were-carried-out-at-months-0,-1,-2,-7-and-13.-participants-were-contacted-by-telephone-between-the-last-two-visits.-blood-sampling-occurred-at-all-visits-

*The second dose of vaccine/placebo will be administered 1 to 2 months after the first dose.
†Month 2 (Visit 3), Month 7 (Visit 4) and Month 13 (Visit 5) occurred within 1, 6 and 12 months of the second vaccination, respectively. RZV, recombinant zoster vaccine; YOA, years of age.

年齢層別の液性免疫応答率20

column-graph-depicting-the-humoral-vaccine-response-rate-in-renal-transplant-patients-stratified-by-age,-specifically-18-to-49-years-of-age-and-those-aged-50-years-and-older.-The-humoral-vaccine-response-rate-in-the-vaccine-group-was-approximately-70-to-80-percent-at-month-2-in-both-age-groups.-at-each-time-point-up-to-the-13-month-of-follow-up,-humoral-vaccine-immune-responses-appeared-higher-in-the-18-to-49-years-of-age-cohort-than-in-the-50-years-and-older-cohort.-post-vaccination,-the-vaccine-response-rate-in-the-placebo-group-remained-near-pre-vaccination-level-

Humoral response was measured at Mo 2, Mo 7 and Mo 13, which occurred within 1, 6 and 12 months of the second vaccination, respectively.
Mo, month; RZV, recombinant zoster vaccine; VRR, vaccine response rate; YOA, years of age.
Reproduced from Vink P et al. 2020 under the terms of a Creative Commons CC-BY licence (http://creativecommons.org/licenses/by/4.0/).

年齢層別の細胞性免疫応答率20

column-graph-depicting-the-vaccine-response-rate-for-cell-mediated-immune-responses-in-renal-transplant-patients-stratified-by-age,-specifically-18-to-49-years-of-age-and-those-aged-50-years-or-older.-The-vaccine-response-rate-for-cell-mediated-immune-response-in-the-vaccine-group-at-month-2-was-approximately-80-percent-and-60-percent-in-18-to-49-years-of-age-cohort-and-the-50-years-and-older-cohort-respectively.-at-each-time-point,-cell-mediated-immune-responses-appeared-to be-higher-in-the-18-to-49-years-of-age-cohort-compared-to-the-50-years-and-older-cohort.-cell-mediated-immune-vaccine-response-rates-in-the-placebo-group-remained-near-the-pre-vaccination-level-

Cell-mediated immune response was measured at Mo 2 and Mo 13, which occurred within 1 and 12 months of the second vaccination, respectively.
CMI, cell-mediated immunity; Mo, month; RZV, recombinant zoster vaccine; VRR, vaccine response rate; YOA, years of age
Reproduced from Vink P et al. 2020 under the terms of a Creative Commons CC-BY licence (http://creativecommons.org/licenses/by/4.0/).

RZVワクチン接種後の液性免疫応答率は、2回目接種1ヶ月後で80.2％、13ヶ月後で66.7％であった。各時点で、液性免疫応答および細胞性免疫応答は、18-49 歳の若年層で 50 歳以上の層よりも高かった。
年齢に関係なく、腎移植後 4～18ヶ月にワクチン投与された場合、gEに対する液性および細胞性免疫応答が誘導された20

column-graph-depicting-the-local and general reactions in-renal-transplant patients-who-received-either-the-recombinant-zoster-vaccine-or-placebo.-in-patients-who-received-the-recombinant-zoster-vaccine,-the-most-frequently-reported-local-adverse-reaction-was-injection-site-pain;-fatigue,-myalgia-and-headache-were-the-most-frequently-reported-general-reactions-

Grade 3 pain defined as significant pain at rest and preventing normal activity; grade 3 redness and swelling defined as surface diameter >100 mm. Fever defined as ≥37.5°C; Fever was not graded in this study. Fever >39.0°C presented as grade 3.
For all others, grade 3 AEs defined as preventing normal activity.

AE, adverse event; GI, gastrointestinal symptoms (nausea, vomiting, diarrhoea and/or abdominal pain); RZV, recombinant zoster vaccine.

Graphs reproduced from Vink P et al. 2020 under the terms of a Creative Commons CC-BY licence (http://creativecommons.org/licenses/by/4.0/), with additional data from ClinicalTrials.gov. NCT02058589.

最も一般的な局所および全身性の特定有害事象は、注射部位疼痛、疲労、筋肉痛でした。9 発現した有害事象は主に軽度から中等度であり、一過性のものでした。全体として、副反応は許容できるものであり、患者の状態から予想されるものでした。20

column-graph-summarising-serious-adverse-events,-related-serious-adverse-events,-fatal-adverse-events,-potential-immune-mediated-diseases-and-unsolicited-adverse-events-in-renal-transplant-patients-who-received-either-the-recombinant--zoster-vaccine-or-placebo.-overall-incidences-of-serious-adverse-events,-deaths,-potential-immune-mediated-diseases-and-unsolicited-adverse-events-were-similar-between-the-recombinant-zoster-vaccine-and-placebo-groups-

AE, adverse event; pIMD, potential immune-mediated disease; RZV, recombinant zoster vaccine; SAE, serious adverse event.
The graph has been independently created by GSK from Vink P, et al. Clin Infect Dis. 2020;70(2):181–190.

RZV 群とプラセボ群との間で、AE、SAE（死亡に至るSAE含む）、免疫の関与が疑われる疾患（pIMD）、生検で証明された拒絶反応、移植臓器の機能変化について、明らかな差は認められませんでした20

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

References

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NX-JP-SGX-WCNT-230014 | December 2023