title: Evaluation of the Long-Term Anti-Human Papillomavirus 6 (HPV6), 11, 16, and 18 Immune Responses Generated by the Quadrivalent HPV Vaccine.
abstract: This quadrivalent human papillomavirus (qHPV) (HPV6, -11, -16, and -18) vaccine long-term follow-up (LTFU) study is an ongoing extension of a pivotal clinical study (FUTURE II) taking place in the Nordic region. The LTFU study was designed to evaluate the effectiveness, immunogenicity, and safety of the qHPV vaccine (Gardasil) for at least 10 years following completion of the base study. The current report presents immunogenicity data from testing samples of the year 5 LTFU visit (approximately 9 years after vaccination). FUTURE II vaccination arm subjects, who consented to being followed in the LTFU, donated serum at regular intervals and in 2012. Anti-HPV6, -11, -16, and -18 antibodies were detected by the competitive Luminex immunoassay (cLIA), and in addition, serum samples from 2012 were analyzed by the total IgG Luminex immunoassay (LIA) (n = 1,598). cLIA geometric mean titers (GMTs) remained between 70% and 93% of their month 48 value depending on HPV type. For all HPV types, the lower bound of the 95% confidence interval (CI) for the year 9 GMTs remained above the serostatus cutoff value. The proportion of subjects who remained seropositive based on the IgG LIA was higher than the proportion based on cLIA, especially for anti-HPV18. As expected, the anti-HPV serum IgG and cLIA responses were strongly correlated for all HPV types. Anti-HPV GMTs and the proportion of vaccinated individuals who are seropositive remain high for up to 9 years of follow-up after vaccination.
authors.affiliation: Department of Research, Cancer Registry of Norway, Oslo, Norway mari.nygard@kreftregisteret.no.
authors.forename: Mari
authors.initials: M
authors.lastname: Nygård
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey, USA.
authors.forename: Alfred
authors.initials: A
authors.lastname: Saah
authors.affiliation: Unit of Virus, Lifestyle and Genes, Danish Cancer Society Research Center, Copenhagen, Denmark.
authors.forename: Christian
authors.initials: C
authors.lastname: Munk
authors.affiliation: Icelandic Cancer Registry, Reykjavik, Iceland Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
authors.forename: Laufey
authors.initials: L
authors.lastname: Tryggvadottir
authors.affiliation: Department of Research, Cancer Registry of Norway, Oslo, Norway.
authors.forename: Espen
authors.initials: E
authors.lastname: Enerly
authors.affiliation: Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Maria
authors.initials: M
authors.lastname: Hortlund
authors.affiliation: Icelandic Cancer Registry, Reykjavik, Iceland Faculty of Medicine, University of Iceland, Reykjavik, Iceland.
authors.forename: Lara G
authors.initials: LG
authors.lastname: Sigurdardottir
authors.affiliation: Merck & Co., Inc., Kenilworth, New Jersey, USA.
authors.forename: Scott
authors.initials: S
authors.lastname: Vuocolo
authors.affiliation: Unit of Virus, Lifestyle and Genes, Danish Cancer Society Research Center, Copenhagen, Denmark Department of Gynecology, Rigshospitalet, University of Copenhagen, Copenhagen, Denmark.
authors.forename: Susanne K
authors.initials: SK
authors.lastname: Kjaer
authors.affiliation: Department of Medical Epidemiology and Biostatistics, Karolinska Institutet, Stockholm, Sweden.
authors.forename: Joakim
authors.initials: J
authors.lastname: Dillner
mesh_terms: D000293:Adolescent; D000914:Antibodies, Viral / Q000097:blood*; D004311:Double-Blind Method; D005260:Female; D005500:Follow-Up Studies; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18 / Q000008:administration & dosage / Q000276:immunology*; D006801:Humans; D007118:Immunoassay; D007074:Immunoglobulin G / Q000097:blood; D030361:Papillomavirus Infections / Q000276:immunology* / Q000517:prevention & control*; D044967:Serum / Q000276:immunology; D013997:Time Factors; D055815:Young Adult
chemical_list: D000914:Antibodies, Viral; D000068857:Human Papillomavirus Recombinant Vaccine Quadrivalent, Types 6, 11, 16, 18; D007074:Immunoglobulin G