乳児における重症RSウイルス関連下気道感染症予防のためのクレスロビマブの使用：Advisory Committee on Immunization Practicesの勧告－アメリカ、2025年

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ホーム IMICライブラリ MMWR抄訳 2025年（Vol.74)乳児における重症RSウイルス関連下気道感染症予防の･･･

MMWR抄訳

2025/08/28Vol. 74 / No. 32

MMWR74(32):508－514
Use of Clesrovimab for Prevention of Severe Respiratory Syncytial Virus– Associated Lower Respiratory Tract Infections in Infants: Recommendations of the Advisory Committee on Immunization Practices — United States, 2025

乳児における重症RSウイルス関連下気道感染症予防のためのクレスロビマブの使用：Advisory Committee on Immunization Practicesの勧告－アメリカ、2025年

乳児に対するユニバーサルなRSウイルス(RSV)予防接種の推奨が導入される以前は、RSVはアメリカにおける乳児の入院の主な原因であった。2023年以降、CDCのAdvisory Committee on Immunization Practices(ACIP)は、1)妊娠中の母親へのRSVワクチン接種(Abrysvo、Pfizer社)、または2)乳児への長時間作用型RSVモノクローナル抗体であるニルセビマブ(Beyfortus、Sanofi/AstraZeneca社)接種のいずれかを通じて、すべての乳児をRSV関連下気道感染症(LRTI)から保護することを推奨している。2025年6月に、アメリカ食品医薬品局(FDA)は、2つ目の長時間作用型RSVモノクローナル抗体であるクレスロビマブ(Enflonsia、Merck社)を、乳児におけるRSV関連LRTIの予防のために承認した。2024年9月以降、ACIP Maternal/Pediatric RSV作業部会は、乳児におけるクレスロビマブの使用に関する安全性と有効性に関するエビデンスを審査してきた。クレスロビマブの150日間にわたるRSV関連の医療的介入を必要としたLRTI予防に対する有効性は60.4%であり、転帰の発生はクレスロビマブ群では2,398人中60人(2.5%)、プラセボ群では1,201人中74人(6.2%)に認められた。RSV関連LRTIによる入院に対する有効性は90.9%で、転帰の発生はクレスロビマブ群では5人(0.2%)、プラセボ群では27人(2.2%)に認められた。接種後1年間の全原因の重篤な有害事象の発現率は、クレズロビマブ投与群(11.5%)とプラセボ投与群(12.4%)で同程度であった。報告された有害事象の大半は軽度または中等度で、易刺激性と傾眠が最も多くみられた。発熱および注射部位反応の発現頻度は試験群間で同程度であった。2025年6月26日に、ACIPは、生後初回のRSV感染症シーズン中、またはRSV感染症シーズンに入って出生し、母親のRSVワクチン接種によって保護されていない8か月未満の乳児におけるRSV関連LRTIの予防に対し、ニルセビマブの代替として使用できる2番目の長時間作用型モノクローナル抗体製品として、クレスロビマブを推奨した。すべての乳児は、これら3つの製品(母体へのRSVワクチン接種、または乳児へのニルセビマブかクレスロビマブの投与)のいずれか1つの使用により、RSV関連LRTIから保護されるべきであり、製品の選択は親の意向、製品の入手可能性、RSVシーズンに応じた乳児の出生時期により決定される必要がある。

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