Published online November 1, 2006
PEDIATRICS Vol. 118 No. 5 November 2006, pp. 2135-2145 (doi:10.1542/peds.2006-0461)
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ARTICLE

Comparison of the Immunogenicity and Reactogenicity of a Prophylactic Quadrivalent Human Papillomavirus (Types 6, 11, 16, and 18) L1 Virus-Like Particle Vaccine in Male and Female Adolescents and Young Adult Women

Stan L. Block, MDa, Terry Nolan, PhD, MBBSb, Carlos Sattler, MDc, Eliav Barr, MDc, Katherine E.D. Giacoletti, MStatc, Colin D. Marchant, MDd, Xavier Castellsagué, MD, PhD, MPHe, Steven A. Rusche, MSc, Suzanne Lukac, BSc, Janine T. Bryan, PhDc, Paul F. Cavanaugh, Jr, PhDc, Keith S. Reisinger, MD, MPHf for the Protocol 016 Study Group

a Kentucky Pediatric Research, Inc, Bardstown, Kentucky
b Murdoch Children's Research Institute and School of Population Health, University of Melbourne, Melbourne, Australia
c Merck Research Laboratories, Wayne, West Point, and Blue Bell, Pennsylvania, and Rahway, New Jersey
d Department of Pediatrics, Boston University School of Medicine, Boston, Massachusetts
e Institut Català d'Oncologia, Servei d'Epidemiologia i Registre del Càncer, L'Hospitalet de Llobregat, Barcelona, Spain
f Primary Physicians Research, Pittsburgh, Pennsylvania

OBJECTIVE. Prophylactic vaccination of 16- to 23-year-old females with a quadrivalent human papillomavirus (types 6, 11, 16, 18) L1 virus-like particle vaccine has been shown to prevent type-specific human papillomavirus infection and associated clinical disease. We conducted a noninferiority immunogenicity study to bridge the efficacy findings in young women to preadolescent and adolescent girls and boys, who represent a primary target for human papillomavirus vaccination.

METHODS. We enrolled 506 girls and 510 boys (10–15 years of age) and 513 females (16–23 years of age). Participants were vaccinated on day 1, at month 2, and at month 6, and serology testing was performed on day 1 and at months 3 and 7 on blinded samples. Neutralizing antibody concentrations were determined using type-specific immunoassays and summarized as geometric mean titers and seroconversion rates. Vaccine tolerability also was assessed.

RESULTS. By month 7, seroconversion rates were ≥99% for all 4 human papillomavirus types in each group. By month 7, compared with women, anti–human papilloma virus geometric mean titers in girls or boys were noninferior and were 1.7- to 2.7-fold higher. Most (>97%) injection-site adverse events were mild to moderate in intensity. Significantly more boys (13.8%) and girls (12.8%) than women (7.3%) reported fevers ≥37.8°C within 5 days of vaccination. Most (96.4%) fevers were mild (<39°C).

CONCLUSIONS. Noninferior immunogenic responses to all 4 human papillomavirus types in the quadrivalent vaccine permit the bridging of efficacy data that were generated in young women to girls. The results in boys lend support for the implementation of gender-neutral human papillomavirus vaccination programs. This vaccine generally was well tolerated.

Key Words: HPV • vaccine • immunogenicity • reactogenicity • pediatric • noninferiority

Abbreviations: HPV—human papillomavirus • VLP—virus-like particle • PCR—polymerase chain reaction • cLIA—competitive Luminex xMAP-based immunoassay • mMU—milliMerck unit • VRC—vaccination report card • AE—adverse event • GMT—geometric mean titer • PPI—per-protocol immunogenicity • CI—confidence interval • SIL—squamous intraepithelial lesion

Accepted Jul 28, 2006.




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