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Effect of Different Human Papillomavirus Serological and DNA Criteria on Vaccine Efficacy Estimates

2014; Oxford University Press; Volume: 180; Issue: 6 Linguagem: Inglês

10.1093/aje/kwu168

1476-6256

Krystle A. Lang Kuhs, Carolina Porras, John T. Schiller, Ana Cecilia Rodríguez, Mark Schiffman, Paula González, Sholom Wacholder, Arpita Ghosh, Yan Li, Douglas R. Lowy, Aimée R. Kreimer, Sylviane Poncelet, John Schussler, Wim Quint, Leen-Jan van Doorn, Mark E. Sherman, Mary Sidawy, Rolando Herrero, Allan Hildesheim, Mahboobeh Safaeian, Krystle A. Lang Kuhs, John T. Schiller, Mark Schiffman, Sholom Wacholder, Douglas R. Lowy, Aimée R. Kreimer, Mark E. Sherman, Allan Hildesheim, Mahboobeh Safaeian, Carolina Porras, Ana Cecilia Rodríguez, Paula González, Rolando Herrero, Paula González, Rolando Herrero, Arpita Ghosh, Yan Li, Sylviane Poncelet, John Schussler, Wim Quint, Leen-Jan van Doorn, Mary Sidawy, Steve Self, Adriana Benavides, Lesvia Calzada, Ruth A. Karron, Ritu Nayar, Nancy Roach, Joanna M. Cain, Diane D. Davey, David L. DeMets, Francisco Fuster García, A.S. Gershon, Elizabeth A. Holly, Henriette Raventós, Wasima Rida, Luis Rosero‐Bixby, Kristen Suthers, Silvia Hunold Lara, Sarah Thomas, Mario Alfaro, Manuel Barrantes, M. Concepción Bratti, Fernando Cárdenas, Bernal Cortés, Albert Espinoza, Yenory Estrada, Paula González, Diego Guillén, Roland Herrero, Silvia E. Jiménez, Jorge Morales, Luis Fernando Botero Villegas, Lidia Ana Morera, Elmer Pérez, Carolina Porras, Ana Cecilia Rodríguez, Lisbi Rivas, Enrique Freer, José Bonilla, Alfanso García-Piñeres, Sandra Silva, Ivannia Atmella, Margarita Ramírez, Allan Hildesheim, Aimée R. Kreimer, Douglas R. Lowy, Nora Macklin, Mark Schiffman, John T. Schiller, Mark E. Sherman, Diane Solomon, Sholom Wacholder, Ligia Pinto, Troy J. Kemp, Claire Eklund, Martha L. Hutchinson, Mary Sidawy, Wim Quint, Leen-Jan van Doorn,

Genital Health and Disease

Two trials of clinically approved human papillomavirus (HPV) vaccines, Females United to Unilaterally Reduce Endo/Ectocervical Disease (FUTURE I/II) and the Papilloma Trial Against Cancer in Young Adults (PATRICIA), reported a 22% difference in vaccine efficacy (VE) against cervical intraepithelial neoplasia grade 2 or worse in HPV-naïve subcohorts; however, serological testing methods and the HPV DNA criteria used to define HPV-unexposed women differed between the studies. We applied previously described methods to simulate these HPV-naïve subcohorts within the Costa Rica HPV16/18 Vaccine Trial and assessed how these criteria affect the estimation of VE. We applied 2 enzyme-linked immunosorbent assay (ELISA) thresholds for HPV16 and HPV18 seropositivity (8 and 7 ELISA units/mL, respectively, for PATRICIA; 54 and 65 ELISA units/mL, respectively, for FUTURE I/II (to approximate the competitive Luminex immunoassay)) and 2 criteria for HPV DNA positivity (12 oncogenic HPV types, plus HPV66 and 68/73 for PATRICIA; or plus HPV6 and 11 for FUTURE I/II). VE was computed in the 2 naïve subcohorts. Using the FUTURE I/II and PATRICIA criteria, VE estimates against cervical intraepithelial neoplasia grade 2 or worse, regardless of HPV type, were 69.0% (95% confidence interval: 40.3%, 84.9%) and 80.8% (95% confidence interval: 52.6%, 93.5%), respectively (P = 0.1). Although the application of FUTURE I/II criteria to our cohort resulted in the inclusion of more sexually experienced women, methodological differences did not fully explain the VE differences.