title: A case study: lessons learned from human papillomavirus vaccine development: approval of a vaccine for use in children and young adolescents for prevention of an adult disease.
abstract: This article presents the adolescent clinical trials program for the quadrivalent HPV vaccine (Merck and Co, Inc, Whitehouse Station, NJ) as a case study of the development of a preventive intervention for use in young adolescents to protect against a future sexually transmitted infection and its associated diseases. In light of similarities in Human Papillomavirus (HPV) and HIV with regard to sexual transmission and the associated social and ethical issues related to prevention trial development, lessons learned from the approach taken to the inclusion of adolescents in the quadrivalent HPV vaccine program have potential relevance to future HIV prevention trials. Epidemiologic support for HPV vaccination in adolescents and a regulatory-approved approach to immunogenicity studies for bridging of efficacy from adults formed the basis for including young adolescents in the HPV program. The successful achievement of regulatory approval for use of this prophylactic intervention in young adolescents for prevention of a sexually transmitted infection that is most frequently not acquired before mid to late adolescence required understanding of the particular challenges of studying the vulnerable adolescent population with respect to issues such as federal regulations, the role of parents, confidentiality, empowerment, and retention, and awareness of the social and political context within which prevention interventions are introduced.
authors.affiliation: Vaccines Clinical Research, Merck, Inc, North Wales, PA 19454, USA. elizabeth_garner@merck.com
authors.forename: Elizabeth I O
authors.initials: EI
authors.lastname: Garner
mesh_terms: D000293:Adolescent; D000328:Adult; D000367:Age Factors; D002648:Child; D017277:Drug Approval; D005260:Female; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D006801:Humans; D008297:Male; D030361:Papillomavirus Infections / Q000517:prevention & control; D053918:Papillomavirus Vaccines / Q000627:therapeutic use*; D033282:Parental Consent; D018579:Patient Selection; D014481:United States; D055815:Young Adult
chemical_list: D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D053918:Papillomavirus Vaccines