2024
Workshop on the design and use of clinical trials with multiple endpoints, with a focus on prevention of RSV
Prunas O, Willemsen J, Warren J, Bont L, Schwartz J, Atwell J, Begier E, Dean N, Hirsch I, Karron R, Klugman K, Kramer R, Leidman E, Link-Gelles R, Nair H, Panozzo C, Pelfrene E, Simões E, Smith P, Srikantiah P, Sundaram M, Thindwa D, Vaughn D, Wilson E, Zar H, Pitzer V, Weinberger D. Workshop on the design and use of clinical trials with multiple endpoints, with a focus on prevention of RSV. Vaccine X 2024, 19: 100509. DOI: 10.1016/j.jvacx.2024.100509.Peer-Reviewed Original ResearchRespiratory syncytial virusRandomized controlled trialsPreventive therapyPrevention of respiratory syncytial virusTrial designSuccess of randomized controlled trialsVaccine trial designDesign randomized controlled trialClinical trial designEstimates of vaccine efficacyPrimary endpointSyncytial virusClinical trialsVaccine efficacyControlled trialsMeta-regression modelsSelection of primary endpointsEndpointSequential trial designTherapyMultiple endpoints
2012
Understanding Reduced Rotavirus Vaccine Efficacy in Low Socio-Economic Settings
Lopman BA, Pitzer VE, Sarkar R, Gladstone B, Patel M, Glasser J, Gambhir M, Atchison C, Grenfell BT, Edmunds WJ, Kang G, Parashar UD. Understanding Reduced Rotavirus Vaccine Efficacy in Low Socio-Economic Settings. PLOS ONE 2012, 7: e41720. PMID: 22879893, PMCID: PMC3412858, DOI: 10.1371/journal.pone.0041720.Peer-Reviewed Original ResearchConceptsLow socio-economic settingRotavirus vaccine efficacyVaccine efficacyRotavirus vaccineSevere diseaseNatural infectionImmunogenicity of vaccinationReduced vaccine efficacySevere rotavirus gastroenteritisReduced efficacyClinical trial resultsLow SES populationsRotavirus gastroenteritisVaccine performanceVaccination programImmune responseEpidemiological factorsVaccineVaccinationTrial resultsInfectionSES populationsEfficacyReduced protectionEfficacy declines