title: Safety and immunogenicity of a 9-valent HPV vaccine in females 12-26 years of age who previously received the quadrivalent HPV vaccine.
abstract: OBJECTIVE
  To assess the safety and immunogenicity of the investigational 9-valent (6/11/16/18/31/33/45/52/58) HPV (9vHPV) vaccine in prior recipients of a 3-dose regimen of quadrivalent (6/11/16/18) HPV (qHPV) vaccine.
  
  
  METHODS
  V503-006 was a randomized, double-blinded, safety/tolerability and immunogenicity study of the 9vHPV vaccine in females 12-26 years of age who were previously vaccinated with qHPV vaccine. Subjects were randomized in a 2:1 ratio to receive 3 doses of 9vHPV vaccine (n=618) or saline placebo (n=306) at day 1, month 2, and month 6. Systemic, injection-site and serious adverse experiences (AEs) were monitored. Serum samples were collected at day 1, month 2, and month 7. Anti-HPV 6/11/16/18/31/33/45/52/58 titers were measured using the 9-valent HPV competitive Luminex Immunoassay (cLIA).
  
  
  RESULTS
  The frequency of injection-site AEs (days 1-5 following any vaccination) was higher in the 9vHPV vaccine group than in the placebo group (91.1% and 43.9%, respectively). The frequencies of vaccine-related systemic AEs (days 1-15 following any vaccination) were generally comparable between the 2 groups (30.6% in the 9vHPV vaccine group, and 25.9% in the placebo group). One vaccine-related serious AE was reported in each of the 9vHPV vaccine and placebo groups. Few subjects (9vHPV=0.5%; placebo=0%) discontinued due to an AE. At 4 weeks post-dose 3, over 98% of subjects in the 9vHPV vaccine group were seropositive for HPV types 31/33/45/52/58, with marked elevations in cLIA geometric mean titers (GMTs) to these HPV types. Anti-HPV 31/33/45/52/58 GMTs were lower than in subjects administered 9vHPV vaccine who had not previously received qHPV vaccine (based on cross-study analyses); the clinical significance of this difference is unknown.
  
  
  CONCLUSIONS
  Administration of a 3-dose regimen of 9vHPV vaccine to adolescent girls and young women 12-26 years of age who are prior qHPV vaccine recipients is highly immunogenic with respect to HPV types 31/33/45/52/58 and generally well tolerated.
authors.affiliation: Department of Microbiology and Infectious Diseases, Royal Women's Hospital, Parkville, Victoria, Australia; Department of Microbiology, Royal Children's Hospital, Murdoch Childrens Research Institute, Parkville, Victoria, Australia; Department of Obstetrics and Gynaecology, University of Melbourne, Parkville, Victoria, Australia. Electronic address: suzanne.garland@thewomens.org.au.
authors.forename: Suzanne M
authors.initials: SM
authors.lastname: Garland
authors.affiliation: Department of Obstetrics and Gynaecology, Prince of Wales Hospital, the Chinese University of Hong Kong, Hong Kong Special Administrative Region.
authors.forename: Tak-Hong
authors.initials: TH
authors.lastname: Cheung
authors.affiliation: Canadian Center for Vaccinology, Izaak Walton Killam Health Centre and Capital Health, Dalhousie University, Canada.
authors.forename: Shelly
authors.initials: S
authors.lastname: McNeill
authors.affiliation: Department of Gynecology, University Hospital of Aarhus, Denmark.
authors.forename: Lone Kjeld
authors.initials: LK
authors.lastname: Petersen
authors.affiliation: Department of Obstetrics and Gynecology, University of Puerto Rico School of Medicine, Puerto Rico.
authors.forename: Josefina
authors.initials: J
authors.lastname: Romaguera
authors.affiliation: Asociacion de Investigación Pediatrica y Adultos (AINPAD A.C.)/StarMedica Morelia, Mexico.
authors.forename: Jorge
authors.initials: J
authors.lastname: Vazquez-Narvaez
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: Oliver
authors.initials: O
authors.lastname: Bautista
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: Christine
authors.initials: C
authors.lastname: Shields
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Vuocolo
authors.affiliation: Merck & Co., Inc., Kenilworth, NJ, USA.
authors.forename: Alain
authors.initials: A
authors.lastname: Luxembourg
mesh_terms: D000293:Adolescent; D000328:Adult; D000914:Antibodies, Viral / Q000097:blood; D002648:Child; D004311:Double-Blind Method; D064420:Drug-Related Side Effects and Adverse Reactions / Q000453:epidemiology / Q000473:pathology; D005260:Female; D006801:Humans; D007118:Immunoassay; D030361:Papillomavirus Infections / Q000517:prevention & control*; D053918:Papillomavirus Vaccines / Q000008:administration & dosage / Q000009:adverse effects* / Q000276:immunology*; D010919:Placebos / Q000008:administration & dosage; D016896:Treatment Outcome; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D053918:Papillomavirus Vaccines; D010919:Placebos
keywords: 9-Valent; GARDASIL; HPV; Immunogenicity; Safety; Vaccine