加衛苗

加衛苗
疫苗說明
目標	人類乳突病毒（16、18、6、11型）
種類	蛋白質亞單位疫苗
臨床資料
商品名（英語：Drug nomenclature）	Gardasil
AHFS/Drugs.com	Monograph
MedlinePlus	a607016
給藥途徑	肌肉注射
ATC碼	J07BM01 (WHO) ;
法律規範狀態
法律規範	美：處方藥（℞-only）;
識別資訊
CAS號	910046-32-1
ChemSpider	none;

加衛苗,（亦作Gardasil、Gardisil、Silgard、recombinant human papillomavirus vaccine [types 6, 11, 16, 18]），^[1]^[2]是人類乳突病毒疫苗的一種，用於預防特定毒株的人類乳突病毒（HPV），^[3]特別是6，11，16和18型。^[4]^[5]約70%的子宮頸癌^[6]^[7]，以及大多數的肛門癌^[8]、外陰癌、陰道癌^[9]和陰莖癌由16和18型HPV病毒感染造成。約90%的尖銳濕疣病例由6型和11型的HPV病毒感染引起。儘管加衛苗不能清除體內已經存在的病毒，仍然推薦HPV陽性患者接種，因為疫苗可以使患者免受其他種類毒株的感染。^[10]加衛苗所預防的毒株都是通過性行為傳播的。加衛苗在2006年6月8日由美國食藥監局認可。至2008年，美國41個州也相繼認可了該疫苗。^[11]除美國外，還有120個國家認可加衛苗。^[12]美國食藥監局建議青春期前及無性行為經驗的人群接種該疫苗。^[4]^[13]^[14]

2014年12月，美國食藥監局又認可了一支基於加衛苗開發的九價HPV疫苗，加衛-9^{[注 1]}。這支疫苗新增了5種HPV毒株的表面蛋白^{[注 2]}^[15]。

註解

^ 亦作：Gardasil 9
^ 這五種毒株分別是HPV-31、HPV-33、HPV-45、HPV-52和HPV-58，20%的子宮頸癌由它們引起。

參考

^ Silgard European Public Assessment Report. 歐洲藥品管理局. 2009-09-25 [2009-12-05]. （原始內容存檔於2009-12-26）.
^ Waknine, Yael. International Approvals: Singulair and Gardasil/Silgard. Medscape Today. 2006-10-02 [2008-12-18]. （原始內容存檔於2013-05-20）.
^ Richwine, Lisa. UPDATE 2-U.S. health officials back safety of Merck vaccine. Reuters. 2009-08-20 [2009-11-12]. （原始內容存檔於2009-08-27）.
^ ^4.0 ^4.1 Markowitz, L. E.; Dunne, E. F.; Saraiya, M.; Lawson, H. W.; Chesson, H.; Unger, E. R.; Centers for Disease Control Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP) (PDF). MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports / Centers for Disease Control. 2007, 56 (RR-2): 1–24 [2016-03-06]. PMID 17380109. （原始內容存檔 (PDF)於2015-09-24）.
^ Centers for Disease Control and Prevention (CDC). FDA licensure of quadrivalent human papillomavirus vaccine (HPV4, Gardasil) for use in males and guidance from the Advisory Committee on Immunization Practices (ACIP) (PDF). MMWR. Morbidity and mortality weekly report. 2010, 59 (20): 630–632 [2016-03-06]. PMID 20508594. （原始內容存檔 (PDF)於2015-09-24）.
^ Lowy DR, Schiller JT. Prophylactic human papillomavirus vaccines. J. Clin. Invest. May 2006, 116 (5): 1167–73 [2009-11-12]. PMC 1451224 . PMID 16670757. doi:10.1172/JCI28607. （原始內容存檔於2008-12-29）.
^ Muñoz N, Bosch FX, Castellsagué X. Against which human papillomavirus types shall we vaccinate and screen? The international perspective. Int. J. Cancer. August 2004, 111 (2): 278–85. PMID 15197783. doi:10.1002/ijc.20244.
^ Cortez, Michelle Fay; Pettypiece, Shannon. Merck Cancer Shot Cuts Genital Warts, Lesions in Men (Update2). Bloomberg News. 2008-11-13 [2009-11-12]. ^{[永久失效連結]}
^ FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers (新聞稿). 美國食品藥品監督管理局 (FDA). 2008-09-12 [2009-11-11]. （原始內容存檔於2010-03-06）.
^ The Ethics of Vaccination. Springer Publishing Company. [2013-09-29].
^ The Ethics of vaccination. Springer Publishing Company. [2013-10-03].
^ Haupt, Richard; Sings, Heather. The efficacy and safety of the quadrivalent human papillomavirus 6/11/16/18 vaccine gardasil. Journal of Adolescent Health. November 2011, 49 (5): 467–475. PMID 22018560. doi:10.1016/jodohealth.2011.07.003.
^ Gardasil full prescribing information (PDF). Merck & Co. [2009-11-11]. （原始內容存檔 (PDF)於2012-03-18）.
^ Gardasil Vaccine Safety. Vaccine Safety & Availability. 美國食品藥品監督管理局 (FDA). 2009-08-20 [2009-11-11]. （原始內容存檔於2009-11-15）.
^ FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV (press release). 2014-12-10 [2015-02-28]. （原始內容存檔於2015-01-10）.

外部連結

官方網站
Silgard EPAR summary for the public（頁面存檔備份，存於網際網路檔案館）
Shi, L; Sings, HL; Bryan, JT; Wang, B; Wang, Y; Mach, H; Kosinski, M; Washabaugh, MW; Sitrin, R; Barr, E. Gardasil: prophylactic human papillomavirus vaccine development – from bench top to bed-side. Clinical Pharmacology & Therapeutics. February 2007, 81 (2): 259–64. ISSN 0009-9236. doi:10.1038/sj.clpt.6100055.
Ireland, Corydon. A Cancer Vaccine is Born. Rochester Review (University of Rochester). 2006, 68 (3) [2016-03-06]. （原始內容存檔於2016-03-04）.
Harris, Gardiner. Panel Unanimously Recommends Cervical Cancer Vaccine for Girls 11 and Up. The New York Times. 2006-06-30 [2016-03-06]. （原始內容存檔於2017-03-11）.
Product Approval Information（頁面存檔備份，存於網際網路檔案館）美國食品藥品監督管理局 (FDA)
Hellerstein, Myra; Thieroff, Amanda. HPV and You: Girls learn about HPV from the commercials, not the classroom. The Indypendent（英語：The Indypendent）. 2007-02-01 [2016-03-06]. （原始內容存檔於2014-12-24）.
McNeil, Donald G., Jr. How a Vaccine Search Ended in Triumph. The New York Times. 2006-08-29 [2016-03-06]. （原始內容存檔於2016-04-15）.

[15] 亦作：Gardasil 9

[16] 這五種毒株分別是HPV-31、HPV-33、HPV-45、HPV-52和HPV-58，20%的子宮頸癌由它們引起。

[silgard-1] Silgard European Public Assessment Report. 歐洲藥品管理局. 2009-09-25 [2009-12-05]. （原始內容存檔於2009-12-26）.

[2] Waknine, Yael. International Approvals: Singulair and Gardasil/Silgard. Medscape Today. 2006-10-02 [2008-12-18]. （原始內容存檔於2013-05-20）.

[3] Richwine, Lisa. UPDATE 2-U.S. health officials back safety of Merck vaccine. Reuters. 2009-08-20 [2009-11-12]. （原始內容存檔於2009-08-27）.

[pmid_17380109-4] 4.0 ^4.1 Markowitz, L. E.; Dunne, E. F.; Saraiya, M.; Lawson, H. W.; Chesson, H.; Unger, E. R.; Centers for Disease Control Prevention (CDC); Advisory Committee on Immunization Practices (ACIP). Quadrivalent Human Papillomavirus Vaccine: Recommendations of the Advisory Committee on Immunization Practices (ACIP) (PDF). MMWR. Recommendations and reports : Morbidity and mortality weekly report. Recommendations and reports / Centers for Disease Control. 2007, 56 (RR-2): 1–24 [2016-03-06]. PMID 17380109. （原始內容存檔 (PDF)於2015-09-24）.

[pmid_20508594-5] Centers for Disease Control and Prevention (CDC). FDA licensure of quadrivalent human papillomavirus vaccine (HPV4, Gardasil) for use in males and guidance from the Advisory Committee on Immunization Practices (ACIP) (PDF). MMWR. Morbidity and mortality weekly report. 2010, 59 (20): 630–632 [2016-03-06]. PMID 20508594. （原始內容存檔 (PDF)於2015-09-24）.

[pmid16670757-6] Lowy DR, Schiller JT. Prophylactic human papillomavirus vaccines. J. Clin. Invest. May 2006, 116 (5): 1167–73 [2009-11-12]. PMC 1451224 . PMID 16670757. doi:10.1172/JCI28607. （原始內容存檔於2008-12-29）.

[Muñoz2004-7] Muñoz N, Bosch FX, Castellsagué X. Against which human papillomavirus types shall we vaccinate and screen? The international perspective. Int. J. Cancer. August 2004, 111 (2): 278–85. PMID 15197783. doi:10.1002/ijc.20244.

[Bloomberg-8] Cortez, Michelle Fay; Pettypiece, Shannon. Merck Cancer Shot Cuts Genital Warts, Lesions in Men (Update2). Bloomberg News. 2008-11-13 [2009-11-12]. ^{[永久失效連結]}

[VulvarCA-9] FDA Approves Expanded Uses for Gardasil to Include Preventing Certain Vulvar and Vaginal Cancers (新聞稿). 美國食品藥品監督管理局 (FDA). 2008-09-12 [2009-11-11]. （原始內容存檔於2010-03-06）.

[10] The Ethics of Vaccination. Springer Publishing Company. [2013-09-29].

[11] The Ethics of vaccination. Springer Publishing Company. [2013-10-03].

[12] Haupt, Richard; Sings, Heather. The efficacy and safety of the quadrivalent human papillomavirus 6/11/16/18 vaccine gardasil. Journal of Adolescent Health. November 2011, 49 (5): 467–475. PMID 22018560. doi:10.1016/jodohealth.2011.07.003.

[gardasilPI-13] Gardasil full prescribing information (PDF). Merck & Co. [2009-11-11]. （原始內容存檔 (PDF)於2012-03-18）.

[FDAgardasil-14] Gardasil Vaccine Safety. Vaccine Safety & Availability. 美國食品藥品監督管理局 (FDA). 2009-08-20 [2009-11-11]. （原始內容存檔於2009-11-15）.

[Gardasil9-17] FDA approves Gardasil 9 for prevention of certain cancers caused by five additional types of HPV (press release). 2014-12-10 [2015-02-28]. （原始內容存檔於2015-01-10）.

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