0000000000353042

AUTHOR

Dong-gun Lee

0000-0003-4655-0641

showing 3 related works from this author

A randomised, placebo-controlled phase 3 study to evaluate the efficacy and safety of ASP0113, a DNA-based CMV vaccine, in seropositive allogeneic ha…

2021

BACKGROUND: Cytomegalovirus (CMV) is a complication of allogeneic haematopoietic cell transplantation (allo-HCT). ASP0113, a DNA-based vaccine, contains two plasmids encoding human CMV glycoprotein B and phosphoprotein 65 (pp65). We assessed ASP0113 in CMV-seropositive allo-HCT recipients. METHODS: In this phase 3, randomised, placebo-controlled study, CMV-seropositive allo-HCT recipients were randomly assigned (1:1) via interactive response technology to receive five injections of 1 mL of 5 mg/mL ASP0113 or placebo. The pharmacist and designated staff were unblinded. Masked syringes maintained the blind for patients and study personnel. Efficacy and safety analyses included patients who re…

medicine.medical_specialtyPhases of clinical research[SDV.CAN]Life Sciences [q-bio]/CancerDiseaseGANCICLOVIRPlacebo01 natural sciencesPROPHYLAXIS03 medical and health sciencesDOUBLE-BLIND0302 clinical medicineMedicine General & Internal[SDV.CAN] Life Sciences [q-bio]/CancerInternal medicineGeneral & Internal MedicinemedicineCYTOMEGALOVIRUS DISEASE030212 general & internal medicine0101 mathematicsAdverse effectlcsh:R5-920Science & Technologybusiness.industryIncidence (epidemiology)010102 general mathematicsGeneral MedicineOdds ratioConfidence interval3. Good healthbusinessComplicationlcsh:Medicine (General)Life Sciences & BiomedicineResearch PaperEClinicalMedicine
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Immunogenicity and safety of the adjuvanted recombinant zoster vaccine in adults with haematological malignancies: a phase 3, randomised, clinical tr…

2019

BACKGROUND: The adjuvanted recombinant zoster vaccine (Shingrix) can prevent herpes zoster in older adults and autologous haemopoietic stem cell transplant recipients. We evaluated the safety and immunogenicity of this vaccine in adults with haematological malignancies receiving immunosuppressive cancer treatments. METHODS: In this phase 3, randomised, observer-blind, placebo-controlled study, done at 77 centres worldwide, we randomly assigned (1:1) patients with haematological malignancies aged 18 years and older to receive two doses of the adjuvanted recombinant zoster vaccine or placebo 1-2 months apart during or after immunosuppressive cancer treatments, and stratified participants acco…

AdultMaleHerpesvirus 3 Humanmedicine.medical_specialtyAdolescentPopulationAntineoplastic AgentsAntibodies ViralPlaceboHematological malignanciesImmunocompromised HostYoung Adult03 medical and health sciences0302 clinical medicineViral Envelope ProteinsInternal medicinemedicineHerpes Zoster VaccineHumansSingle-Blind Method030212 general & internal medicineeducationAdverse effectFatigueImmunity CellularVaccines Syntheticeducation.field_of_studyVaccinesReactogenicityH. Zosterbusiness.industryImmunogenicityMiddle AgedCD4 Lymphocyte CountInjection Site ReactionVaccinationClinical trialInfectious DiseasesHematologic Neoplasms030220 oncology & carcinogenesisH. Zoster; Vaccines; Hematological malignanciesFemaleZoster vaccinebusinessVaccinemedicine.drug
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Effect of Recombinant Zoster Vaccine on Incidence of Herpes Zoster After Autologous Stem Cell Transplantation A Randomized Clinical Trial

2019

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AdultMalemedicine.medical_specialtyHerpes Zoster Vaccinemedicine.medical_treatmentvirusesVaccines Synthetic/administration & dosageHematopoietic stem cell transplantationPlaceboInjections IntramuscularTransplantation Autologous01 natural sciencesHerpes Zoster Vaccine/administration & dosage03 medical and health sciences0302 clinical medicineAutologous stem-cell transplantationAdjuvants ImmunologicInternal medicinehemic and lymphatic diseasesmedicineHumansSingle-Blind Method030212 general & internal medicine0101 mathematicsAdverse effectHospitalization/statistics & numerical dataProportional Hazards ModelsImmunocompromised hostintegumentary systembusiness.industryIncidence (epidemiology)010102 general mathematicsvirus diseasesGeneral MedicineMiddle AgedNeuralgia Postherpetic/prevention & controlTransplantationsurgical procedures operativeHerpes Zoster/epidemiologyhematopoietic stem cell transplantationoncologyincidenceFemaleZoster vaccinebusinessFollow-Up Studiesmedicine.drug
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