Effect of different human papillomavirus serological and dnacriteria on vaccine efficacy estimates

Krystle A.Lang Kuhs, Carolina Porras, John T. Schiller, Ana Cecilia Rodriguez, Mark Schiffman, Paula Gonzalez, 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

Research output: Contribution to journalArticlepeer-review

7 Scopus citations


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.

Original languageEnglish (US)
Pages (from-to)599-607
Number of pages9
JournalAmerican journal of epidemiology
Issue number6
StatePublished - Sep 15 2014


  • Human papillomavirus
  • Methodological differences
  • Naïve population
  • Vaccine efficacy

ASJC Scopus subject areas

  • Epidemiology


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