Estimating human papillomavirus vaccine efficacy from a single-arm trial: Proof-of-principle in the Costa Rica Vaccine Trial

CONCLUSION: We demonstrate that a single-arm design yields valid VE estimates with similar precision to an RCT. Single-arm studies can reduce the sample size and costs of future HPV vaccine trials while avoiding concerns related to unvaccinated control groups.TRIAL REGISTRATION: ClinicalTrials.gov Identifier: NCT00128661.PMID:37040086 | DOI:10.1093/jnci/djad064

Source: Cancer Control - April 11, 2023 Category: Cancer & Oncology Authors: Brian Befano Nicole G Campos Didem Egemen Rolando Herrero Mark Schiffman Carolina Porras Douglas R Lowy Ana Cecilia Rodriguez John T Schiller Rebecca Ocampo Allan Hildesheim Joshua N Sampson Shrutikona Das Aim ée R Kreimer Li C Cheung Costa Rica HPV Vacc Source Type: research