A Randomized, Double-Blind, Phase III Study of the Immunogenicity and Safety of a 9-Valent Human Papillomavirus L1 Virus-Like Particle Vaccine (V503) Versus Gardasil® in 9–15-Year-Old Girls. Issue 9 (September 2015)

• Record Type: Journal Article
• Authors: Vesikari, Timo; Brodszki, Nicholas; van Damme, Pierre; Diez-Domingo, Javier; Icardi, Giancarlo; Petersen, Lone Kjeld; Tran, Clément; Thomas, Stéphane; Luxembourg, Alain; Baudin, Martine
• Is Part Of: Pediatric infectious disease journal. Volume 34:Issue 9(2015)
• Publication Date: 2015-09
• Subjects: Communicable diseases in children -- Periodicals; Infection in children -- Periodicals; 618.929
• DOI: 10.1097/INF.0000000000000773
• Languages: English
• ISSNs: 0891-3668

Abstract

<abstract> <title> <x xml:space="preserve">Abstract</x> </title> <sec> <title>Background:</title> <p>A 9-valent human papillomavirus (9vHPV) vaccine has been developed to prevent infections and diseases related to HPV 6/11/16/18 [as per the licensed quadrivalent HPV (qHPV) vaccine], as well as 5 additional oncogenic HPV types (HPV 31/33/45/52/58). Compared with the qHPV vaccine, the 9vHPV vaccine potentially increases the coverage of protection from 70% to 90% of cervical cancers. We compared the immunogenicity and safety of the 9vHPV vaccine versus the qHPV vaccine in 9–15-year-old girls.</p> </sec> <sec> <title>Methods:</title> <p>Participants (n = 600) were randomized to receive 9vHPV or qHPV vaccines on day 1, month 2 and month 6. Serology testing was performed on day 1 and month 7. HPV type-specific antibody titers (anti-HPV 6/11/16/18/31/33/45/52/58) were determined by competitive Luminex immunoassay and expressed as geometric mean titers and seroconversion rates. Vaccine safety was also assessed.</p> </sec> <sec> <title>Results:</title> <p>The HPV 6/11/16/18 immune responses elicited by the 9vHPV vaccine were comparable with those elicited by the qHPV vaccine. All participants (except 1 for HPV 45) receiving the 9vHPV vaccine seroconverted for HPV 31/33/45/52/58. The 9vHPV and qHPV vaccines showed comparable safety profiles, although the incidence of injection-site swelling was higher in the 9vHPV vaccine group.</p> </sec> <sec> <title>Conclusions:</title> <p>In addition to immune responses to HPV 31/33/45/52/58, a 3-dose regimen of the 9vHPV vaccine elicited a similar immune response to HPV 6/11/16/18 when compared with the qHPV vaccine in girls aged 9–15 years. The safety profile was also similar for the 2 vaccines.</p> </sec> </abstract>