TY - JOUR
T1 - Effect of different human papillomavirus serological and dnacriteria on vaccine efficacy estimates
AU - Kuhs, Krystle A.Lang
AU - Porras, Carolina
AU - Schiller, John T.
AU - Rodriguez, Ana Cecilia
AU - Schiffman, Mark
AU - Gonzalez, Paula
AU - Wacholder, Sholom
AU - Ghosh, Arpita
AU - Li, Yan
AU - Lowy, Douglas R.
AU - Kreimer, Aimée R.
AU - Poncelet, Sylviane
AU - Schussler, John
AU - Quint, Wim
AU - Van Doorn, Leen Jan
AU - Sherman, Mark E.
AU - Sidawy, Mary
AU - Herrero, Rolando
AU - Hildesheim, Allan
AU - Safaeian, Mahboobeh
N1 - Publisher Copyright:
© The Author 2014.
PY - 2014/9/15
Y1 - 2014/9/15
N2 - 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 HPVunexposed 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.
AB - 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 HPVunexposed 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.
KW - Human papillomavirus
KW - Methodological differences
KW - Naïve population
KW - Vaccine efficacy
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U2 - 10.1093/aje/kwu168
DO - 10.1093/aje/kwu168
M3 - Article
C2 - 25139208
AN - SCOPUS:84907487061
SN - 0002-9262
VL - 180
SP - 599
EP - 607
JO - American journal of epidemiology
JF - American journal of epidemiology
IS - 6
ER -