Long-term effectiveness and immunogenicity of quadrivalent HPV vaccine in young men: 10-year end-of study analysis.

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Journal of Clinical Oncology
36, no. 15_suppl (May 20 2018) 1553-1553.
Cancer Prevention, Hereditary Genetics, and Epidemiology
Long-term effectiveness and immunogenicity of quadrivalent HPV vaccine in young men: 10-year end-of study analysis.
Stephen Goldstone, Anna Giuliano, Joel Palefsky, Alain Luxembourg, Show More
DOI: 10.1200/JCO.2018.36.15_suppl.1553 Journal of Clinical Oncology – published online before print June 1, 2018
Background: The quadrivalent human papillomavirus (qHPV) vaccine prevented HPV6/11/16/18-related persistent infection and external genital lesions in young men in an international, randomized, placebo-controlled pivotal efficacy study. We report the end-of-study analysis of a long-term follow up (LTFU) extension study that assessed the effectiveness and immunogenicity of the qHPV vaccine through 10 years after the first dose.
Methods: In the 3-year base study, young men (16-26 years old) were randomized 1:1 to receive a 3-dose regimen of qHPV vaccine or placebo; we report results from those who received 3 doses of qHPV vaccine in the base study and participated in the LTFU. The entire study population was assessed annually in the 7-year LTFU for HPV6/11-related genital warts and HPV6/11/16/18-related external genital lesions (EGL), and a subpopulation was assessed for HPV6/11/16/18-related anal intraepithelial neoplasia (AIN) or anal cancer. Persistence of anti-HPV6/11/16/18 antibodies was evaluated from serum samples collected 48-72 months (first LTFU visit) and 10 years post-Dose 1.
Results: A total of 917 participants were followed for effectiveness for up to 11.5 years (median: 9.5 years) post-Dose 3. There were no new cases of HPV6/11-related genital warts, HPV6/11/16/18-related EGL, or HPV6/11/16/18-related high-grade AIN during the LTFU (Years 3 to 10 of the study) in the per-protocol population. One case of low-grade AIN (AIN1) with positive PCR results for HPV6 and HPV58 was reported. Seropositivity rates assessed by competitive Luminex immunoassay (cLIA) were > 97% at Month 7 (1 month post-Dose 3); remained high over time for HPV6, 11, and 16; and decreased over time for HPV18 (40.2% at Month 120 by cLIA). Seropositivity rates at Month 120 assessed by IgG Luminex immunoassay (a more sensitive assay) were > 90% for all 4 HPV types.
Conclusions: The qHPV vaccine provides durable protection from vaccine-type–related anogenital disease and elicits persistent HPV antibody responses through 10 years post-vaccination onset in 16-26–year-old men. Clinical trial information: NCT00090285.