50歳以上の成人に対する肺炎球菌結合型ワクチンの使用に関する推奨の拡大：Advisory Committee on Immunization Practicesの推奨 ― アメリカ、2024年

日本語
English

ホーム IMICライブラリ MMWR抄訳 2025年（Vol.74)50歳以上の成人に対する肺炎球菌結合型ワクチンの使･･･

MMWR抄訳

2025/01/09Vol. 74 / No. 1

MMWR74(1):1－8
Expanded Recommendations for Use of Pneumococcal Conjugate Vaccines Among Adults Aged ≥50 Years: Recommendations of the Advisory Committee on Immunization Practices — United States, 2024

50歳以上の成人に対する肺炎球菌結合型ワクチンの使用に関する推奨の拡大：Advisory Committee on Immunization Practicesの推奨 ― アメリカ、2024年

2024年10月以前に、Advisory Committee on Immunization Practices(ACIP)は、65歳以上のすべての成人、肺炎球菌感染症のリスクがあるが肺炎球菌結合型ワクチン(PCV)を接種していないか、またはワクチン接種歴が不明な19～64歳の人に対して、PCVの使用を推奨していた。PCVの選択肢には、20価PCV(PCV20：プレベナー20、Wyeth Pharmaceuticals社)単独または21価PCV(PCV21：キャップバックス、Merck Sharp & Dohme社)単独、あるいは15価PCV(PCV15：バクニュバンス、Merck Sharp & Dohme社)と23価肺炎球菌多糖体ワクチン(PPSV23：ニューモバックス23、Merck Sharp & Dohme社)のシリーズ接種が含まれていた。2024年10月23日、ACIPは50歳以上のPCV未接種の成人すべてに対しPCVの単回接種を推奨した。リスクのある19歳～49歳の成人とPCV13ワクチン接種済みの成人に対するPCVの推奨に変更はない。13価PCV(PCV13：プレベナー13、Wyeth Pharmaceuticals社)による肺炎球菌ワクチン接種シリーズを開始した成人に対しては、PCV20またはPCV21の使用に関する追加の推奨事項がある。今回、これらの推奨に対して考慮されたエビデンスをまとめ、PCV使用に関する最新の臨床ガイダンスを提供する。ACIP肺炎球菌ワクチンワークグループは、年齢に基づくPCV推奨の50～64歳の成人への拡大に関する審議の指針とするために、Evidence to Recommendations frameworkを採用した。肺炎球菌性肺炎は入院した肺炎症例全体の12％～13％を占め、アメリカでは毎年約225,000名の成人が入院に至っていると推定されている。50～64歳における侵襲性肺炎球菌感染症(IPD)の人と肺炎球菌性肺炎で入院した人の約90％がリスクを有していた。CDCのActive Bacterial Coreサーベイランスデータによると、50～64歳の成人において、2018年～2022年(PCV20が広く使用される前、成人を対象としたPCV21承認前)のIPD症例の56％および83％は、それぞれPCV20とPCV21に含まれる肺炎球菌血清型によるものであった。50～64歳の成人の32％～54％がリスクに基づく肺炎球菌ワクチン接種の対象となるリスク疾患を有していると推定されている。一方、2022年のBehavioral Risk Factor Surveillance Systemのデータでは、年齢に基づく推奨を受けた65歳以上の成人のうち70％が肺炎球菌ワクチンを接種したのに比較し、リスクに基づくワクチン接種を推奨された50～64歳の成人のうち、ワクチンを接種したのはわずか37％であり、ワクチン接種率の人種格差が示された。アメリカの多くの状況では、PCV21は他の推奨されているPCVよりも多くの流行する肺炎球菌株をカバーすることが期待されている。肺炎球菌感染症の30％以上の特定の集団では血清型4が原因であり、血清型4を含む肺炎球菌ワクチン(PCV20単独、PCV15とPPSV23の接種シリーズ)は、PCV21よりも地域で流行している株に対してより広い血清型をカバーすることが期待されている。

References

CDC. Active bacterial core surveillance (ABCs): ABCs bact facts interactive data dashboard. Atlanta, GA: US Department of Health and Human Services, CDC; 2024. ＜https://www.cdc.gov/abcs/bact-facts/data-dashboard.html＞
Matanock A, Lee G, Gierke R, Kobayashi M, Leidner A, Pilishvili T. Use of 13-valent pneumococcal conjugate vaccine and 23-valent pneumococcal polysaccharide vaccine among adults aged ≥65 years: updated recommendations of the Advisory Committee on Immunization Practices. MMWR Morb Mortal Wkly Rep 2019;68:1069–75. PMID:31751323 ＜https://doi.org/10.15585/mmwr.mm6846a5＞
Kobayashi M. Summary of work group interpretation of EtR and policy options: PCV use in adults aged ≥50 years [Presentation slides]. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; October 23, 2024. ＜https://www.cdc.gov/acip/downloads/slides-2024-10-23-24/04-Kobayashi-Pneumococcal-508.pdf＞
Food and Drug Administration. Package insert: PREVNAR 20. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2024. ＜https://www.fda.gov/media/149987/download?attachment＞
Food and Drug Administration. Package insert: CAPVAXIVE. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2024. ＜https://www.fda.gov/media/179426/download?attachment＞
Food and Drug Administration. Package insert: VAXNEUVANCE. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2024. ＜https://www.fda.gov/media/150819/download?attachment＞
Food and Drug Administration. Package insert: PNEUMOVAX23. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2024. ＜https://www.fda.gov/media/80547/download＞
Kobayashi M, Leidner AJ, Gierke R, et al. Use of 21-valent pneumococcal conjugate vaccine among U.S. adults: recommendations of the Advisory Committee on Immunization Practices—United States, 2024. MMWR
Morb Mortal Wkly Rep 2024;73:793–8. PMID:39264843 ＜https://doi.org/10.15585/mmwr.mm7336a2＞
Food and Drug Administration. Package insert: Prevnar 13. Silver Spring, MD: US Department of Health and Human Services, Food and Drug Administration; 2024. ＜https://www.fda.gov/files/vaccines%2C%20blood%20%26%20biologics/published/Package-Insert------Prevnar-13.pdf＞
Leidner AJ, Bletnitsky S. Summary of three economic analyses on the use of PCVs among 50–64 year old adults in the United States [Presentation slides]. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; October 23, 2024. ＜https://www.cdc.gov/acip/downloads/slides-2024-10-23-24/03-Leidner-Pneumococcal-508.pdf＞
Kobayashi M, Farrar JL, Gierke R, et al. 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. MMWR Morb Mortal Wkly Rep 2022;71:109–17. PMID:35085226 ＜https://doi.org/10.15585/mmwr.mm7104a1＞
Kobayashi M, Pilishvili T, Farrar JL, et al. Pneumococcal vaccine for adults aged ≥19 years: recommendations of the Advisory Committee on Immunization Practices, United States, 2023. MMWR Recomm Rep 2023;72:1–39. PMID:37669242 ＜https://doi.org/10.15585/mmwr.rr7203a1＞
Isturiz R, Grant L, Gray S, et al. Expanded analysis of 20 pneumococcal serotypes associated with radiographically confirmed community-acquired pneumonia in hospitalized US adults. Clin Infect Dis 2021;73:1216–22. PMID:33982098 ＜https://doi.org/10.1093/cid/ciab375＞
Self WH, Johnson KD, Resser JJ, et al.; PNEUMO Study Investigators. Prevalence, clinical severity, and serotype distribution of pneumococcal pneumonia among adults hospitalized with community-acquired pneumonia in Tennessee and Georgia, 2018–2022. Clin Infect Dis 2024;79:838–47. PMID:39016606 ＜https://doi.org/10.1093/cid/ciae316＞
Ramirez J, Furmanek S, Chandler TR, et al.; The University of Louisville Pneumonia Study Group. Epidemiology of pneumococcal pneumonia in Louisville, Kentucky, and its estimated burden of disease in the United States. Microorganisms 2023;11:2813 PMID:38004825 ＜https://doi.org/10.3390/microorganisms11112813＞
Kobayashi M. Evidence to recommendations framework: PCV20 use among adults who previously received PCV13 [Presentation slides]. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; October 19, 2022. ＜https://stacks.cdc.gov/view/cdc/122357＞
Kobayashi M. Summary of work group interpretations of EtR and policy option on PCV21 use in adults [Presentation slides]. Presented at the Advisory Committee on Immunization Practices meeting, Atlanta, GA; June 27, 2024. ＜https://www.cdc.gov/acip/downloads/slides-2024-06-26-28/04-Pneumococcal-Kobayashi-508.pdf＞
Song JY, Chang CJ, Andrews C, et al.; V114-016 (PNEU-PATH) study group. Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, followed by sequential PPSV23 vaccination in healthy adults aged ≥50 years: a randomized phase III trial (PNEU-PATH). Vaccine 2021;39:6422–36. PMID:34489128 ＜https://doi.org/10.1016/j.vaccine.2021.08.038＞
Mohapi L, Pinedo Y, Osiyemi O, et al.; V114-018 (PNEU-WAY) study group. Safety and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in adults living with HIV. AIDS 2022;36:373–82. PMID:34750291 ＜https://doi.org/10.1097/QAD.0000000000003126＞
Platt HL, Cardona JF, Haranaka M, et al. A phase 3 trial of safety, tolerability, and immunogenicity of V114, 15-valent pneumococcal conjugate vaccine, compared with 13-valent pneumococcal conjugate vaccine in adults 50 years of age and older (PNEU-AGE). Vaccine 2022;40:162–72. PMID:34507861 ＜https://doi.org/10.1016/j.vaccine.2021.08.049＞
Severance R, Schwartz H, Dagan R, et al. Safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, administered concomitantly with influenza vaccine in healthy adults aged ≥50 years: a randomized phase 3 trial (PNEU-FLU). Hum Vaccin Immunother 2022;18:1–14. PMID:34726574 ＜https://doi.org/10.1080/21645515.2021.1976581＞
Merck Sharp & Dohme. Safety, tolerability, and immunogenicity of V110 or V114 co-administered with a booster dose of mRNA-1273 in healthy adults (V110–911). Rahway, NJ: Merck Sharp & Dohme; 2024. ＜https://ClinicalTrials.gov/show/NCT05158140＞
Simon JK, Staerke NB, Hemming-Harlo M, et al.; V114-020 PNEUTRUE study group. Lot-to-lot consistency, safety, tolerability, and immunogenicity of V114, a 15-valent pneumococcal conjugate vaccine, in healthy adults aged ≥50 years: a randomized phase 3 trial (PNEUTRUE). Vaccine 2022;40:1342–51. PMID:35039194 ＜https://doi.org/10.1016/j.vaccine.2021.12.067＞
Essink B, Sabharwal C, Cannon K, et al. Pivotal phase 3 randomized clinical trial of the safety, tolerability, and immunogenicity of 20-valent pneumococcal conjugate vaccine in adults aged ≥18 years. Clin Infect Dis 2022;75:390–8. PMID:34940806 ＜https://doi.org/10.1093/cid/ciab990＞
Hurley D, Griffin C, Young M Jr, et al. Safety, tolerability, and immunogenicity of a 20-valent pneumococcal conjugate vaccine (PCV20) in adults 60 to 64 years of age. Clin Infect Dis 2021;73:e1489–97. PMID:32716500 ＜https://doi.org/10.1093/cid/ciaa1045＞
Haranaka M, Young Song J, Huang KC, et al. A phase 3 randomized trial of the safety and immunogenicity of 20-valent pneumococcal conjugate vaccine in adults ≥60 years of age in Japan, South Korea, and Taiwan. Vaccine 2024;42:1071–7. PMID:38267330 ＜https://doi.org/10.1016/j.vaccine.2024.01.004＞
Platt H, Omole T, Cardona J, et al. Safety, tolerability, and immunogenicity of a 21-valent pneumococcal conjugate vaccine, V116, in healthy adults: phase 1/2, randomised, double-blind, active comparator-controlled, multicentre, US-based trial. Lancet Infect Dis 2023;23:233–46. PMID:36116461 ＜https://doi.org/10.1016/S1473-3099(22)00526-6＞
Platt HL, Bruno C, Buntinx E, et al.; STRIDE-3 Study Group. Safety, tolerability, and immunogenicity of an adult pneumococcal conjugate vaccine, V116 (STRIDE-3): a randomised, double-blind, active comparator controlled, international phase 3 trial. Lancet Infect Dis 2024;24:1141–50. PMID:38964361 ＜https://doi.org/10.1016/S1473-3099(24)00344-X＞
Scott P, Haranaka M, Choi JH, et al.; STRIDE-6 study group. A phase 3 clinical study to evaluate the safety, tolerability, and immunogenicity of V116 in pneumococcal vaccine-experienced adults 50 years of age or older (stride-6). Clin Infect Dis 2024;79:1366–74. PMID:39082735 ＜https://doi.org/10.1093/cid/ciae383＞
Merck Sharp & Dohme. A phase 3 randomized, double-blind, placebocontrolled clinical study to evaluate the safety, tolerability, and immunogenicity of V116 when administered concomitantly with influenza vaccine in adults 50 years of age or older. Rahway, NJ: Merck Sharp & Dohme; 2023. ＜https://clinicaltrials.gov/study/NCT05526716＞
Merck Sharp & Dohme. A phase 3, multicenter, randomized, doubleblind, active comparator-controlled study to evaluate the safety, tolerability, and immunogenicity of V116 in adults living with HIV. Rahway, NJ: Merck Sharp & Dohme; 2023. ＜https://clinicaltrials.gov/study/NCT05393037＞
Merck Sharp & Dohme. Safety and immunogenicity of V116 in pneumococcal vaccine-naïve adults 50 years of age or older (V116–010, STRIDE-10). Rahway, NJ: Merck Sharp & Dohme; 2024. ＜https://www.clinicaltrials.gov/study/NCT05569954?term=V116-010&rank=1＞
Kroger A, Bahta L, Long S, Sanchez P. General best practice guidelines for immunization. Atlanta, GA: US Department of Health and Human Services, CDC; 2024. ＜www.cdc.gov/vaccines/hcp/acip-recs/general- recs/downloads/general-recs.pdf＞