高齢者におけるRSウイルスワクチンの使用：Advisory Committee on Immunization Practicesの推奨 ― アメリカ、2023年

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ホーム IMICライブラリ MMWR抄訳 2023年（Vol.72)高齢者におけるRSウイルスワクチンの使用：Advi･･･

MMWR抄訳

2023/07/21Vol. 72 / No. 29

MMWR72(29):793－801
Use of Respiratory Syncytial Virus Vaccines in Older Adults: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023

高齢者におけるRSウイルスワクチンの使用：Advisory Committee on Immunization Practicesの推奨 ― アメリカ、2023年

RSウイルス(RSV)は高齢者の重症呼吸器疾患の原因となり、RSV症例はほぼ高齢者にて発生し、65歳以上の高齢者では年間60,000～160,000人が入院し、6,000～10,000人が死亡している。2023年5月、FDAは60歳以上の成人におけるRSV関連下気道疾患(LRTD)予防のための最初のワクチンを承認し、Advisory Committee on Immunization Practices(ACIP)は2023年6月21日、60歳以上の成人にRSVワクチンの単回接種を推奨することを決定した。GSK社のワクチンRSVPreF3(Arexvy)は膜融合前遺伝子組換えRSV F糖タンパク質(RSVPreF3)抗原とAS01Eアジュバントを組み合わせ、1回0.5mLを接種する。17カ国にて進行中の第Ⅲ相二重盲検プラセボ対照試験のデータが評価され、60歳以上の正常免疫者24,973名を無作為に介入群(preFタンパク質120µg)と対照群に分け、2021年5月～2022年4月(シーズン1)、2022年8月～2023年3月(シーズン2)にて有効性を解析し、ワクチン接種から有効性追跡調査終了までの期間は約15カ月であった。GSKワクチン1回接種のRSV関連LRTD予防の有効性はシーズン1が82.6％、シーズン2が56.1％、全体では74.5％であり、RSV関連の医療介入(入院、外来受診)予防の有効性は77.5％であった。GSKワクチンの安全性に関するエビデンスは2つの第Ⅲ相試験と60歳以上の成人201名が参加した第Ⅰ/Ⅱ相試験データにて評価され、重篤な反応原性イベントの発現率は介入群が3.8％、対照群が0.9％であり、重篤な有害事象(SAE)発現率は介入群が4.4％、対照群が4.3％であった。接種後42日以内の炎症性神経イベントは3名(/17,992名)にて報告され[ギランバレー症候群(GBS)1名、急性散在性脳脊髄炎(ADEM)2名]、ADEMの1名が死亡したが、診断検査未実施のため、治験責任医師は診断をADEMから低血糖症および認知症に修正した。Pfizer社のワクチンRSVPreF(Abrysvo)は遺伝子組換え安定化preFワクチン(1回量:0.5mL)であり、有効性エビデンスは7カ国にて進行中の第Ⅲ相試験データにて評価され、60歳以上の免疫正常者36,862名を無作為に介入群と対照群に1:1にて割り付け、2021年8月～2022年10月(シーズン1)、2022年7月～2023年1月(シーズン2)にて解析した。RSV関連LRTD予防の有効性はシーズン1が88.9％、シーズン2が78.6％、全体では84.4％であり、RSV関連医療介入予防の有効性は81.0％であった。安全性のエビデンスは進行中の第Ⅲ相試験と65歳以上の高齢者91名が参加した第Ⅰ/Ⅱ相試験データにて評価され、重篤な反応原性イベントの発現率は介入群が1.0％、対照群が0.7％、SAE発現率は介入群が4.3％、対照群が4.1％であった。接種後42日以内の炎症性神経イベントは20,255名中3名に報告された(GBS 1名、Miller Fisher症候群1名、未分化運動感覚軸索性多発性ニューロパチー1名)。以上の結果より、ACIPは60歳以上の成人にRSVワクチン単回接種を推奨し、安全性に関しては今後、市販後調査により潜在的リスクに関する追加のエビデンスが得られるまではワクチン接種により恩恵を受ける可能性が高い人を対象とすべきである。

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