GARDASIL: prophylactic human papillomavirus vaccine development--from bench top to bed-side.
GARDASIL (Merck, Whitehouse Station, NJ) is a non-infectious recombinant, quadrivalent vaccine prepared from the highly purified virus-like particles (VLPs) of the major capsid proteins of human papillomavirus (HPV) types 6, 11, 16, and 18. GARDASIL is the first vaccine approved for use in women aged 9-26 years for the prevention of cervical cancer and genital warts, as well as vulvar and vaginal precancerous lesions. This report describes some of the key preclinical efforts, achievements in pharmaceutical development, in vivo animal evaluation, and clinical trial data.
Shi
L
L
Merck Research Laboratories, West Point, Pennsylvania, USA. Li_Shi@merck.com
Sings
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Bryan
J T
JT
Wang
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B
Wang
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Mach
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Kosinski
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Washabaugh
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Sitrin
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Barr
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D000293:Adolescent; D000328:Adult; D052685:Alphapapillomavirus / Q000276:immunology*; D000818:Animals; D002648:Child; D002986:Clinical Trials as Topic; D004353:Drug Evaluation, Preclinical / Q000379:methods; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control* / Q000821:virology; D053918:Papillomavirus Vaccines / Q000008:administration & dosage* / Q000276:immunology
D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines