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Pediatr Infect Dis J. 2015 Sep;34(9):992-8. doi: 10.1097/INF.0000000000000773.

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.

Author information

1
From the *Vaccine Research Centre, University of Tampere, Tampere, Finland; †Children's Hospital, Lund University, Lund, Sweden; ‡Centre for the Evaluation of Vaccination, Vaccine and Infectious Disease Institute, University of Antwerp, Antwerp, Belgium; §Vaccine Research Department, FISABIO-Public Health, Valencia, Spain; ¶Department of Health Sciences, University of Genoa, IRCSS AOU San Martino-IST, Genoa, Italy; ‖Department of Gynaecology and Obstetrics, Aarhus University Hospital, Skejby, Denmark; **Sanofi Pasteur MSD, Lyon, France; and ††Merck & Co., Inc., Whitehouse Station, NJ.

Abstract

BACKGROUND:

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.

METHODS:

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.

RESULTS:

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.

CONCLUSIONS:

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.

PMID:
26090572
DOI:
10.1097/INF.0000000000000773
[Indexed for MEDLINE]

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