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ホームIMICライブラリMMWR抄訳2022年(Vol.71)アメリカの成人における15価肺炎球菌結合型ワクチン・・・

MMWR抄訳

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2022/01/28Vol. 71 / No. 4

MMWR71(4):109-117
Use of 15-Valent Pneumococcal Conjugate Vaccine and 20-Valent Pneumococcal Conjugate Vaccine Among U.S. Adults: Updated Recommendations of the Advisory Committee on Immunization Practices — United States, 2022

アメリカの成人における15価肺炎球菌結合型ワクチンおよび20価肺炎球菌結合型ワクチンの使用:Advisory Committee on Immunization Practicesの最新推奨 ― アメリカ、2022年

20価肺炎球菌結合型ワクチン(PCV20)および15価肺炎球菌結合型ワクチン(PCV15)への抗体反応を13価肺炎球菌結合型ワクチン(PCV13)と比較した試験に基づき、2021年、PCV20およびPCV15は18歳以上の成人を対象にFDAにより認可された。2021年10月20日、Advisory Committee on Immunization Practices(ACIP)は65歳以上のすべての成人、特定の基礎疾患または他のリスク因子を有し、過去に肺炎球菌結合型ワクチン接種歴がない、または接種歴が不明な19~64歳の成人に対し、PCV20単独またはPCV15と23価肺炎球菌多糖体ワクチン(PPSV23)の接種シリーズを利用することを推奨している。ACIPは2021年2月から10月にかけて肺炎球菌疾患の疫学および成人におけるPCV15およびPCV20の使用に関する考察を検討するため、Grading of Recommendations, Assessment, Development and Evaluationアプローチを使用し、PCV15およびPCV20の免疫原性および安全性に関するエビデンスの質を評価し、Evidence to Recommendationを使用して65歳以上の成人と特定の基礎疾患を有する若年成人におけるPCV15およびPCV20の有益性と有害性に関するエビデンスを評価した。PCV15はPCV13の血清型に加えて、肺炎球菌多糖体血清型22F、33Fを含み、PCV20はPCV13の血清型に加えて、肺炎球菌多糖体血清型8、10A、11A、12F、15B、22F、33Fを含み、PPSV23は 2、8、9N、10A、11A、12F、15B、17F、20、22F、33F血清型を含む。2018年~2019年の65歳以上における侵襲性肺炎球菌疾患(IPD)罹患率は10万人あたり24例であり、PCV13血清型が症例の27%を占め、PCV15、PCV20、PPSV23の追加血清型はそれぞれ15%、27%、35%であった。特定の基礎疾患のある19~64歳ではPCV13血清型がIPD症例の30%を占めており、PCV15、PCV20、PPSV23はそれぞれ13%、28%、43%であった。2010年~2016年のアメリカ人10万人あたりの市中肺炎による入院例は65歳未満が126~422例、65歳以上が847~3,365例であり、PCV13血清型による市中肺炎による入院例は4.6%、PCV15、PCV20はそれぞれ1.4%、3.3%であった。PCV15およびPCV20の免疫原性はPCV13共通血清型に関しては非劣性を示し、追加血清型に関しては有意に高い反応性を示した。最も多く報告された副反応はPCV15が注射部位痛、疲労、筋肉痛、PCV20が注射部位痛、筋肉痛、疲労、頭痛、関節痛であった。接種から6カ月後までの重篤な有害事象の発現率はPCV13が2.4%、PCV15が2.5%、PCV20では1.5%と報告された。以上、PCV20単独接種、またはPCV15とPPSV23のシリーズ接種は、65歳以上または特定の基礎疾患がある19~64歳の人における肺炎球菌疾患の罹患率を減少させ、PCV13単独接種またはPCV13とPPSV23のシリーズ接種と同等の免疫原性および安全性が示された。費用対効果の研究では65歳以上の成人に対するPCV20単独接種、またはPCV15とPPSV23のシリーズ接種では、費用削減が認められた。新たな肺炎球菌ワクチンの推奨事項として、PCVの接種歴がない、または接種歴が不明な65歳以上の成人は、PCV20またはPCV15を1回接種すべきである。PCV15を使用した場合は、その後PPSV23を接種する。PCVの接種歴がない、または接種歴が不明な19~64歳の成人で、特定の基礎疾患やその他のリスク因子を有する場合も65歳の成人と同様とする。PCV15とPPSV23の接種間隔は1年以上が推奨されているが、免疫不全状態、人工内耳植え込み、脳脊髄液漏の成人に対しては、IPDリスクを最小限にするため8週間以上の間隔を検討することができる。

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