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HIV（ヒト免疫不全ウイルス）感染者

HIVキャリア19

HIVに感染した成人を対象に、アジュバント添加組換え帯状疱疹ワクチン(RZV)を筋肉内に3回接種し、安全性と免疫原性を評価した第Ⅰ/Ⅱa相無作為化観察者盲検プラセボ対照多施設共同試験。19,32

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試験デザイン19

study-design-to-evaluate-the-safety-and-immunogenicity-of-the-recombinant-zoster-vaccine-in-comparison-with-placebo-when-administered-in-a-three-dose-schedule-to-adult-h-i-v-infected-subjects.-94-recipients-recieved-anti-retroviral-therapy-with-a-c-d-4-plus-t-cell-count-of-greater-than-or-equal-to-200-cells-per-cubic-millimetre;-14-recipients-recieved-anti-retroviral-therapy-with-a-c-d-4-plus-t-cell-count-between-50-and-199-cells-per-cubic-millimetre;-15-recipients-recieved-anti-retroviral-therapy-with-a-c-d-4-plus-t-cell-count-of-greater-than-or-equal-to-500-cells-per-cubic-millimetre.-vaccination-occurred-at-months-0,-2-and-6.-blood-sampling-occurred-at-months-0,-1,-2,-3,-6,-7-and-18.

ART, anti-retroviral therapy; HIV, human immunodeficiency virus; RZV, recombinant zoster vaccine.
The figure is adapted with the permission of Oxford University Press. It was first published in Berkowitz EM, et al. 2015. J Infect Dis. 211(8):1279–1287.

液性免疫応答*19

line-graph-depicting-the-anti-glycoprotein-e-antibody-geometric-mean-concentration-in-patients-infected-with-h-i-v.-the-anti-glycoprotein-e-antibody-geometric-mean-concentration-remained-above-pre-vaccination-concentrations-up-to-18-months-post-final-recombinant-zoster-vaccine-dose,-whereas-anti-glycoprotein-e-antibody-geometric-mean-concentrations-in-the-placebo-group-remained-at-pre-vaccination-level-throughout-the-study-

Figure adapted with permission from Berkowitz EM et al. J Infect Dis 2015;211:1279–1292.
*Humoral response was defined as a ≥4-fold increase in GMC in subjects who were seropositive before vaccination or a GMC ≥4 times the cut-off value in subjects seronegative before vaccination.
gE, glycoprotein E; GMC, geometric mean concentration; Mo, month; Pre, pre-vaccination; RZV, recombinant zoster vaccine.

細胞性免疫応答19

line-graph-illustrating-the-median-c-d-4-plus-t-cell-frequency-of-glycoprotein-e-specific-c-d-4-plus-t-cells-in-patients-infected-with-the-human-immunodeficiency-virus.-in-the-recombinant-zoster-vaccine-group-c-d-4-plus-t-cell-frequency-peaked-1-month-post-dose-2-but-did-not-increase-further-after-the-third-dose.-the-median-frequency-of-glycoprotein-e-specific-c-d-4-plus-t-cells-for-the-placebo-group-remained-at-pre-vaccination-level-throughout-the-study-

Figure adapted with permission from Berkowitz EM et al. J Infect Dis 2015;211:1279–1292.
CMI, cell-mediated immunity; gE, glycoprotein E; Mo, month; Pre, pre-vaccination; RZV, recombinant zoster vaccine.

RZVワクチン接種後の液性および細胞性免疫応答は、2 回目の接種後に 50 歳以上の健常人にみられたものと同等でした。3回目のワクチン投与では、gE特異的な液性および細胞性免疫応答に関して、2回投与に対する実質的な追加効果は認められませんでした。19
ワクチン接種1年後におけるgE特異的CD4+T細胞応答は、自然な帯状疱疹発症の1ヵ月後に見られた値よりも高い結果でした。19

column-graph-summarising-the-local-and-general-reactions-in-patients-infected-with-h-i-v-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-reaction-was-injection-site-pain;-the-most-frequently-reported-general-reaction-was-fatigue,-followed-by-myalgia-and-headache-

Graph adapted from data in Berkowitz EM, et al. J Infect Dis. 2015;211(8):1279–1287.
†Grade 3 reactions defined as AEs that prevent normal everyday activities (grade 3 redness and swelling is defined as ≥100 mm; grade 3 fever is defined as an oral/axillary temperature of >39.0°C).
AE, adverse event; GI, gastrointestinal (nausea, vomiting, diarrhoea and abdominal pain); RZV, recombinant zoster vaccine.

最も一般的な局所および全身性の有害事象は、注射部位の疼痛、疲労、筋肉痛でした。19 発現した有害事象は一過性のもので試験のコンプライアンスに影響するものではありませんでした。19

column-graph-showing-serious-adverse-events,-related-serious-adverse-events,-fatal-adverse-events,-potential-immune-mediated-diseases-and-unsolicited-adverse-events-in-h-i-v-infected-adults-who-received-either-the-recombinant-zoster-vaccine-or-placebo.-there-were-no-reported-incidences-of-related-serious-adverse-events,-fatal-adverse-events-and-potential-immune-mediated-diseases-during-the-entire-study-period.-serious-adverse-events-and-unsolicited-adverse-events-were-similar-between-the-recombinant-zoster-vaccine-and-placebo-groups-

The graph has been independently created by GSK from Berkowitz EM, et al. J Infect Dis. 2015;211(8):1279–1287.
AE, adverse event; HIV, human immunodeficiency virus; pIMD, potential immune-mediated disease; RZV, recombinant zoster vaccine; SAE, serious adverse event.

HIV感染者におけるRZVの忍容性が確認されました。ワクチン接種に関連したSAE、死亡に至るSAE、免疫介在性炎症性疾患の新たな発症は報告されませんでした。さらに、RZVは18ヵ月の試験期間中、HIVリボ核酸（RNA）濃度およびCD4+T細胞数のいずれにも持続的な影響を与えませんでした。19

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, recombinant 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-230015 | December 2023