Randomized trial of an alternate human papillomavirus vaccine administration schedule in college-aged women

Journal of Women's Health
Richard K ZimmermanMarian Michaels

Abstract

Human papillomavirus (HPV) vaccine is effective against HPV types 16 and 18, which cause 70% of cervical cancers. The three-dose vaccination schedule at 0, 2, and 6 months may be inconvenient for college-aged women. This study assessed noninferiority of the immune response to an alternate vaccination schedule at 0, 2, and 12 months. Two hundred nonpregnant women, aged 18-23 years, with <5 sexual partners were randomized into standard and alternate schedules. Blood samples were drawn before dose 1 and 2-6 weeks after dose 3 and analyzed with the competitive Luminex immunoassay. Seropositives at baseline were eliminated from analyses by HPV type. Log-transformed titers were used to calculate HPV type-specific geometric mean titers (GMTs) and 95% confidence intervals (CI) for each group. Noninferiority was tested against a one-sided null hypothesis that the post-dose 3 GMT ratio of the alternate to standard schedule was < or =0.5 for each HPV type. One hundred eighty-eight women completed the study, with all 12 dropouts in the alternate schedule group (p < 0.001). Antibody responses in the alternate schedule were noninferior to the standard schedule for all vaccine types (p < 0.0001). Among the per-protocol population, GMTs (95% C...Continue Reading

References

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Citations

Nov 14, 2013·PloS One·Diane M HarperJeffrey Wall
Feb 7, 2014·The Journal of Infectious Diseases·D Scott LaMontagne
Jul 9, 2014·Expert Review of Vaccines·Margaret A StanleyAnna R Giuliano
Dec 5, 2012·Vaccine·Lauri E MarkowitzJulia M L Brotherton
Mar 12, 2011·Academic Pediatrics·Elyse Olshen KharbandaVaughn I Rickert
Feb 9, 2011·Vaccine·Weiyi TanEmmanuel B Walter
Jul 16, 2015·Human Vaccines & Immunotherapeutics·Richard K ZimmermanMary Patricia Nowalk
Sep 26, 2015·Journal of the Pediatric Infectious Diseases Society·Timo VesikariJohn L Perez
Jan 23, 2020·Human Vaccines & Immunotherapeutics·Allison M BradyGitika Panicker
May 10, 2018·The Cochrane Database of Systematic Reviews·Marc ArbynPierre Pl Martin-Hirsch

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