乳幼児におけるRSウイルス疾患予防としてのニルセビマブの使用：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)乳幼児におけるRSウイルス疾患予防としてのニルセビ･･･

MMWR抄訳

2023/08/25Vol. 72 / No. 34

MMWR72(34):920－925
Use of Nirsevimab for the Prevention of Respiratory Syncytial Virus Disease Among Infants and Young Children: Recommendations of the Advisory Committee on Immunization Practices — United States, 2023

乳幼児におけるRSウイルス疾患予防としてのニルセビマブの使用：Advisory Committee on Immunization Practicesの推奨 ― アメリカ、2023年

RSウイルス(RSV)はアメリカの乳児における入院の主な原因となっている。 2023年7月、FDAは乳幼児におけるRSV関連の下気道感染症(LRTI)を予防するための受動免疫として、長時間作用型モノクローナル抗体であるニルセビマブを承認した。2021年10月から、Advisory Committee on Immunization Practices(ACIP)のMaternal and Pediatric RSVワークグループは、乳幼児におけるニルセビマブの安全性および有効性に関するエビデンスを検討してきた。2023年8月3日、RSVシーズン中に出生または出生後初めてのRSVシーズンを迎える生後8カ月未満のすべての乳児、重症RSV疾患リスクが高く、2回目のRSVシーズンを迎える生後8～19カ月の乳幼児に対し、ACIPはニルセビマブを推奨した。ニルセビマブの有効性は、RSVシーズン中に出生または出生後初めてのRSVシーズンを迎える生後8カ月未満の乳児を対象に注射後150日間にわたって評価された。Grading of Recommendations, Assessment, Development, and Evaluationsの評価として、第3相試験および第2相b試験の結果が統合された。医療的観点から受診したRSV関連LRTIの予防に対する有効性は79.0％、RSV関連LRTIによる入院の予防に対する有効性は80.6％、RSV関連LRTIによる集中治療室入院の予防に対する有効性は90.0％であった。どちらの試験でもRSVに起因する死亡はなく、ニルセビマブ群の重篤な有害事象の発現率はプラセボ群と比較して増加しなかった。COVID-19パンデミック前のパターンに基づけば、ニルセビマブはアメリカ本土の大半の地域で10月から3月末まで投与される。ニルセビマブは、重症RSV疾患のリスクが高い乳幼児における重症RSV疾患を予防する可能性がある。出血リスクが高い乳幼児にニルセビマブを投与する場合、医療従事者はACIPの予防接種に関する一般的なベストプラクティスガイドラインに従う必要がある。ニルセビマブは、過去の接種後または製品成分に対する重度のアレルギー反応(アナフィラキシーなど)の既往のある人には禁忌である。また、ニルセビマブを単独で接種後に副反応が発現することがある。

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