title: Early assessment of the efficacy of a human papillomavirus type 16 L1 virus-like particle vaccine.
abstract: A post hoc analysis was performed using combined data from two Phase I tolerability/immunogenicity studies of monovalent human papillomavirus type 11 (HPV11) or HPV16 L1 virus-like particle (VLP) vaccines. The goal was to determine if the HPV16 L1 VLP vaccine protected against HPV16 infection. Vaccine or placebo was given at 0, 2 and 6 months. HPV16 infection was defined by positive polymerase chain reaction (PCR) results following vaccination. The incidence of HPV infection was observed to be 0 cases per 100 person-years at risk in the vaccine group, and 5 cases per 100 person-years at risk in the control group. These results support the institution of larger efficacy trials for HPV L1 VLP vaccines.
authors.affiliation: Department of Medicine, Indiana University School of Medicine, Emerson Hall Room 435, 545 Barnhill Drive, Indianapolis 46022, USA. darbrow@iupui.edu
authors.forename: Darron R
authors.initials: DR
authors.lastname: Brown
authors.forename: Kenneth H
authors.initials: KH
authors.lastname: Fife
authors.forename: Cosette M
authors.initials: CM
authors.lastname: Wheeler
authors.forename: Laura A
authors.initials: LA
authors.lastname: Koutsky
authors.forename: Lisa M
authors.initials: LM
authors.lastname: Lupinacci
authors.forename: Radha
authors.initials: R
authors.lastname: Railkar
authors.forename: Gretchen
authors.initials: G
authors.lastname: Suhr
authors.forename: Eliav
authors.initials: E
authors.lastname: Barr
authors.forename: Anthony
authors.initials: A
authors.lastname: Dicello
authors.forename: Weili
authors.initials: W
authors.lastname: Li
authors.forename: Judith F
authors.initials: JF
authors.lastname: Smith
authors.forename: Amha
authors.initials: A
authors.lastname: Tadesse
authors.forename: Kathrin U
authors.initials: KU
authors.lastname: Jansen
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000032:analysis / Q000096:biosynthesis; D017931:DNA Primers; D004306:Dose-Response Relationship, Immunologic; D023381:Endpoint Determination; D005260:Female; D005500:Follow-Up Studies; D006801:Humans; D027383:Papillomaviridae / Q000276:immunology*; D030361:Papillomavirus Infections / Q000276:immunology / Q000517:prevention & control*; D053918:Papillomavirus Vaccines; D011863:Radioimmunoassay; D020133:Reverse Transcriptase Polymerase Chain Reaction; D013048:Specimen Handling; D013997:Time Factors; D019444:Vaccines, DNA / Q000009:adverse effects / Q000276:immunology; D014765:Viral Vaccines / Q000009:adverse effects / Q000276:immunology*
chemical_list: D000914:Antibodies, Viral; D017931:DNA Primers; D053918:Papillomavirus Vaccines; D019444:Vaccines, DNA; D014765:Viral Vaccines