2024
Randomized Phase II Trial of Imiquimod with or without 9-Valent HPV Vaccine versus Observation in Patients with High-grade Pre-neoplastic Cervical Lesions (NCT02864147)
Sheth S, Oh J, Bellone S, Siegel E, Greenman M, Mutlu L, McNamara B, Pathy S, Clark M, Azodi M, Altwerger G, Andikyan V, Huang G, Ratner E, Kim D, Iwasaki A, Levi A, Buza N, Hui P, Flaherty S, Schwartz P, Santin A. Randomized Phase II Trial of Imiquimod with or without 9-Valent HPV Vaccine versus Observation in Patients with High-grade Pre-neoplastic Cervical Lesions (NCT02864147). Clinical Cancer Research 2024, 30: of1-of10. PMID: 38592381, DOI: 10.1158/1078-0432.ccr-23-3639.Peer-Reviewed Original ResearchConceptsRandomized phase II trialCD4/CD8 T cellsT cellsHPV clearanceArm BNo significant differenceClinical surveillanceRate of HPV clearanceSecondary outcomesPre-neoplastic cervical lesionsCervical intraepithelial neoplasiaT cell infiltrationT cell responsesSignificant differenceCIN3 patientsIntraepithelial neoplasiaArm ACervical lesionsImiquimod groupSurveillance armVaginal suppositoriesProspective trialsArm CHPV vaccinationImiquimod
2021
Effectiveness of HPV vaccine by age at vaccination and number of doses: protocol for a population-based matched case–control study
Oliveira CR, Ortiz AM, Sheth SS, Shapiro ED, Niccolai LM. Effectiveness of HPV vaccine by age at vaccination and number of doses: protocol for a population-based matched case–control study. BMJ Open 2021, 11: e043093. PMID: 33875441, PMCID: PMC8057558, DOI: 10.1136/bmjopen-2020-043093.Peer-Reviewed Case Reports and Technical NotesConceptsHigh-grade cervical lesionsPre-licensure clinical trialsHPV vaccineCase-control studyNumber of dosesClinical trialsFirst human papillomavirus (HPV) vaccineMultivariate conditional logistic regressionNormal Pap test resultsReal-world clinical settingHuman papillomavirus vaccinePap test resultsHPV types 16Time of immunisationReal-world effectivenessConditional logistic regressionInstitutional review boardDate of testingPapillomavirus vaccineCervical lesionsPotential confoundersVaccine programMedical recordsPersistent infectionType 16