2025
Safety and immunogenicity of an adjuvanted chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of other alphavirus vaccines versus alphavirus vaccine-naive controls: an open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled study
Hamer M, McCarty J, Pierson B, Regules J, Mendy J, Sanborn A, Gardner C, Haller J, Gregory M, Liggett D, Glass P, Ghosh N, Royalty Tredo S, Warfield K, Burke C, Lee C, Saunders D, Bedell L, Richardson J. Safety and immunogenicity of an adjuvanted chikungunya virus virus-like particle (CHIKV VLP) vaccine in previous recipients of other alphavirus vaccines versus alphavirus vaccine-naive controls: an open-label, parallel-group, age-matched, sex-matched, phase 2 randomised controlled study. The Lancet Microbe 2025, 101000. PMID: 39954701, DOI: 10.1016/j.lanmic.2024.101000.Peer-Reviewed Original ResearchGeometric mean titresCHIKV VLPsVaccine recipientsVLP vaccineAdverse eventsSex-matchedAlphavirus vaccinesOpen-labelParallel-groupAge-matchedVirus-like particlesPrimary immunogenicity endpointNeutralising antibodiesVEEV vaccinesAntibody seroconversion ratesPhase 2 randomised controlled trialFisher's exact testClinical study sitesStatistically significant differenceImmunogenicity endpointsSeroconversion ratesCompare immunogenicitySingle doseAntibody increaseExact test
2024
5-year vaccine protection following a single dose of Vi-tetanus toxoid conjugate vaccine in Bangladeshi children (TyVOID): a cluster randomised trial
Qadri F, Khanam F, Zhang Y, Biswas P, Voysey M, Mujadidi Y, Kelly S, Bhuiyan A, Rajib N, Hossen I, Rahman N, Islam S, Pitzer V, Kim Y, Clemens J, Pollard A, Liu X. 5-year vaccine protection following a single dose of Vi-tetanus toxoid conjugate vaccine in Bangladeshi children (TyVOID): a cluster randomised trial. The Lancet 2024, 404: 1419-1429. PMID: 39396349, DOI: 10.1016/s0140-6736(24)01494-6.Peer-Reviewed Original ResearchConceptsTyphoid conjugate vaccineJapanese encephalitis vaccineVaccine effectivenessRandomised controlled trialsConjugate vaccineFollow-upTyphoid feverControlled trialsVaccine protectionChildren aged 9 monthsIncreased risk of typhoid feverAnti-Vi IgGRisk of typhoid feverVaccine efficacy dataTest-negative designAged 9 monthsUnvaccinated individualsHigh-burden countriesIncidence rate ratiosAnalyses of vaccine effectivenessSingle-doseSingle doseDecay of antibodiesSubgroup analysisBooster doseA Randomized, Double-Blind, Parallel-Group Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of CMAB015, a Candidate Secukinumab Biosimilar, with Its Reference Product Cosentyx® in Healthy Chinese Male Subjects
Yao F, Wang C, Ding J, Zhang Q, Zheng L, Zhang Q, Yang T, Zhang X, Shan Y, Hou S, Wang H, Zhou R, Hu W. A Randomized, Double-Blind, Parallel-Group Phase I Study Comparing the Pharmacokinetics, Safety, and Immunogenicity of CMAB015, a Candidate Secukinumab Biosimilar, with Its Reference Product Cosentyx® in Healthy Chinese Male Subjects. Drug Design Development And Therapy 2024, 18: 3891-3901. PMID: 39224901, PMCID: PMC11368109, DOI: 10.2147/dddt.s470619.Peer-Reviewed Original ResearchConceptsHealthy Chinese male subjectsChinese male subjectsGeometric mean ratiosAnti-drug antibodiesDouble-blindMale subjectsRates of anti-drug antibodiesPK parametersNon-radiographic axial spondyloarthritisIncidence of TEAEsPhase I studyPrimary study endpointInterleukin (IL)-17AArea under the curveEnthesitis-related arthritisTreatment of psoriasisConfidence intervalsSafety profileSingle doseHidradenitis suppurativaSecukinumabStudy endpointAdverse eventsAxial spondyloarthritisImmunogenicity analysisReactive axillary lymph nodes after COVID-19 mRNA vaccination: comparison of mRNA vs. attenuated whole-virus vaccines
Adin M, Isufi E, Wu J, Pang Y, Nguyen D, Has D, Caner C, Aboueldaha N, Mossa-Basha M, Pucar D. Reactive axillary lymph nodes after COVID-19 mRNA vaccination: comparison of mRNA vs. attenuated whole-virus vaccines. Nuclear Medicine Communications 2024, 45: 474-480. PMID: 38465449, DOI: 10.1097/mnm.0000000000001833.Peer-Reviewed Original ResearchAxillary lymph nodesWhole virus vaccineLymph nodesMRNA vaccinesNatural courseValue of clinical parametersCOVID-19 mRNA vaccinesPredictive value of clinical parametersDose of vaccine administrationPET-CT studiesCohort of oncology patientsDeauville criteriaPET criteriaClinical parametersYounger patientsSingle doseModerna recipientsJ&J vaccinePET-positiveMultivariate analysisVaccine typesOncology patientsPredictive valueVaccine administrationModerna vaccineSafety, feasibility, tolerability, and clinical effects of repeated psilocybin dosing combined with non-directive support in the treatment of obsessive-compulsive disorder: protocol for a randomized, waitlist-controlled trial with blinded ratings
Ching T, Amoroso L, Bohner C, D’Amico E, Eilbott J, Entezar T, Fitzpatrick M, Fram G, Grazioplene R, Hokanson J, Jankovsky A, Kichuk S, Martins B, Patel P, Schaer H, Shnayder S, Witherow C, Pittenger C, Kelmendi B. Safety, feasibility, tolerability, and clinical effects of repeated psilocybin dosing combined with non-directive support in the treatment of obsessive-compulsive disorder: protocol for a randomized, waitlist-controlled trial with blinded ratings. Frontiers In Psychiatry 2024, 14: 1278823. PMID: 38264632, PMCID: PMC10803438, DOI: 10.3389/fpsyt.2023.1278823.Peer-Reviewed Original ResearchObsessive-compulsive disorderPrimary outcomeNon-directive supportClinical effectsTreatment-refractory obsessive-compulsive disorderRefractory obsessive-compulsive disorderSingle-dose trialBlinded ratingsWaitlist-controlled trialDose selection strategiesOCD symptom reductionTreatment of OCDEffects of psilocybinSingle-site trialOCD symptomsInstitutional review boardBlinded independent ratersTrials of psilocybinYale-Brown ObsessiveWaitlist control designPrimary endpointMore dosesFuture trialsSingle dosePsilocybin treatmentLongitudinal phase 2 clinical trials of live, attenuated tularemia vaccine in healthy research laboratory workers
Saunders D, Pierson B, Haller J, Norris S, Cardile A, Reisler R, Okwesili A, Boudreau E, Rusnak J, Danner D, Purcell B, Barth J, Tompkins E, Downs I, Liggett D, Pettit P, Pratt T, Goldberg M, Kortepeter M, Guerena F, Aldis J, Keshtkar-Jahromi M, Pittman P. Longitudinal phase 2 clinical trials of live, attenuated tularemia vaccine in healthy research laboratory workers. Frontiers In Bacteriology 2024, 2: 1289461. DOI: 10.3389/fbrio.2023.1289461.Peer-Reviewed Original ResearchLive vaccine strainLaboratory workersClinical trialsPhase 2 clinical trialPrimary immunogenicity endpointIntracellular bacterium Francisella tularensisMultiple clinical trialsHuman challenge studiesInvestigational new drug applicationRisk laboratory workersBacterium Francisella tularensisImmunogenicity endpointsInitial vaccinationSecond doseHigh morbidityAerosol doseSingle doseVaccine protocolsTularemia vaccineWeek 4Comparator dataMortality rateNew drug applicationsResponse ratePneumonic disease
2023
Safety, pharmacokinetics and pharmacodynamics of HRS‐7535, a novel oral small molecule glucagon‐like peptide‐1 receptor agonist, in healthy participants: A phase 1, randomized, double‐blind, placebo‐controlled, single‐ and multiple‐ascending dose, and food effect trial
Wu J, Zhou R, Zhang Q, Zhang Q, Qin H, Ye Z, Xu Y, Feng S, Shu C, Shen Y, Fan Y, Wang Q, Du Y, Hu W. Safety, pharmacokinetics and pharmacodynamics of HRS‐7535, a novel oral small molecule glucagon‐like peptide‐1 receptor agonist, in healthy participants: A phase 1, randomized, double‐blind, placebo‐controlled, single‐ and multiple‐ascending dose, and food effect trial. Diabetes Obesity And Metabolism 2023, 26: 901-910. PMID: 38100147, DOI: 10.1111/dom.15383.Peer-Reviewed Original ResearchGlucagon-like peptide-1 receptor agonistsPeptide-1 receptor agonistsSingle ascending doseMAD partsReceptor agonistGeometric mean tNovel glucagon-like peptide-1 receptor agonistFood effectHealthy participantsMultiple ascending dosePhase 1 trialType 2 diabetesGLP-1RAsPrimary endpointSingle doseDay 29Day 28Mean reductionClinical developmentMean TBody weightPharmacokineticsPlaceboTolerabilityEffect trialProgressive shingles in a toddler due to reactivation of Varicella Zoster vaccine virus four days after infection with SARS-CoV-2; a case report
Miller C, Taylor-Salmon E, Emuren L, Landry M, Gershon A, Miller G. Progressive shingles in a toddler due to reactivation of Varicella Zoster vaccine virus four days after infection with SARS-CoV-2; a case report. BMC Infectious Diseases 2023, 23: 854. PMID: 38057696, PMCID: PMC10698951, DOI: 10.1186/s12879-023-08809-5.Peer-Reviewed Original ResearchConceptsVaricella-zoster virusVZV reactivationVaccine-strain varicella-zoster virusSevere acute respiratory syndrome coronavirus 2Acute respiratory syndrome coronavirus 2Latent varicella zoster virusSymptomatic COVID-19 infectionRespiratory syndrome coronavirus 2SARS-CoV2 infectionSyndrome coronavirus 2COVID-19 infectionVaccine-type strainsSARS-CoV-2Vesicular rashPediatric patientsSignificant morbidityClinical syndromeCoronavirus 2Single doseCase reportGeneral populationMechanical traumaDisease processHZ casesPhysiologic stressSingle-Dose Psilocybin Treatment for Major Depressive Disorder
Raison C, Sanacora G, Woolley J, Heinzerling K, Dunlop B, Brown R, Kakar R, Hassman M, Trivedi R, Robison R, Gukasyan N, Nayak S, Hu X, O’Donnell K, Kelmendi B, Sloshower J, Penn A, Bradley E, Kelly D, Mletzko T, Nicholas C, Hutson P, Tarpley G, Utzinger M, Lenoch K, Warchol K, Gapasin T, Davis M, Nelson-Douthit C, Wilson S, Brown C, Linton W, Johnson M, Ross S, Griffiths R. Single-Dose Psilocybin Treatment for Major Depressive Disorder. JAMA 2023, 330: 843-853. PMID: 37651119, PMCID: PMC10472268, DOI: 10.1001/jama.2023.14530.Peer-Reviewed Original ResearchConceptsMajor depressive disorderSheehan Disability Scale scoresAdverse eventsDisability scale scorePsilocybin treatmentDay 43Scale scoreSecondary outcomesSingle doseDepressive disorderExclusion criteriaPsychological supportMontgomery-Asberg Depression Rating Scale scoreSerious treatment-emergent adverse eventsDay 8Key secondary outcome measuresTreatment-emergent adverse eventsDepression Rating Scale scoresActive substance use disorderFifth Edition diagnosisIdentical-appearing capsulesOverall adverse eventsPhase 2 trialSerious adverse eventsSevere adverse eventsThe effect of single dose albendazole (400 mg) treatment on the human gut microbiome of hookworm-infected Ghanaian individuals
Appiah-Twum F, Akorli J, Okyere L, Sagoe K, Osabutey D, Cappello M, Wilson M. The effect of single dose albendazole (400 mg) treatment on the human gut microbiome of hookworm-infected Ghanaian individuals. Scientific Reports 2023, 13: 11302. PMID: 37438457, PMCID: PMC10338455, DOI: 10.1038/s41598-023-38376-3.Peer-Reviewed Original ResearchConceptsHookworm infectionAlbendazole treatmentMicrobiota compositionStool samplesGut microbiomeGut microbiome dysbiosisInfection cure rateKintampo North MunicipalityPre-treatment statePotential microbial biomarkersAdjunct treatmentAnthelminthic therapySingle doseCure rateMicrobiome dysbiosisTreatment outcomesGut homeostasisPharmacological responseProbiotic supplementationGut microbiotaUninfected individualsCommensal bacteriaInfected individualsTherapy outcomeHuman gut microbiomeSub-acute effects of psilocybin on EEG correlates of neural plasticity in major depression: Relationship to symptoms
Skosnik P, Sloshower J, Safi-Aghdam H, Pathania S, Syed S, Pittman B, D’Souza D. Sub-acute effects of psilocybin on EEG correlates of neural plasticity in major depression: Relationship to symptoms. Journal Of Psychopharmacology 2023, 37: 687-697. PMID: 37392016, DOI: 10.1177/02698811231179800.Peer-Reviewed Original ResearchConceptsAntidepressant effectsTheta powerMajor depressive disorderEffects of psilocybinSub-acute effectsLong-term alterationsMeasures of depressionSingle doseDepressive disorderMajor depressionDepressive symptomsPlaceboSymptoms 2Depression symptomsEEG theta powerNeural plasticityNeuroplasticityEEG biomarkersSymptomsSerotonergic psychedelicsPotential mechanismsDepressionSustained changesElectroencephalographic correlatesPsilocybinChanges in synaptic markers after administration of ketamine or psychedelics: a systematic scoping review
Zhornitsky S, Oliva H, Jayne L, Allsop A, Kaye A, Potenza M, Angarita G. Changes in synaptic markers after administration of ketamine or psychedelics: a systematic scoping review. Frontiers In Psychiatry 2023, 14: 1197890. PMID: 37435405, PMCID: PMC10331617, DOI: 10.3389/fpsyt.2023.1197890.Peer-Reviewed Reviews, Practice Guidelines, Standards, and Consensus StatementsAdministration of ketamineSynaptic markersSubstance use disordersPrefrontal cortexSingle doseBasal conditionsStress-related reductionPsilocybin/psilocinVerbal memory performanceWeb of ScienceKetamine treatmentSystematic scoping reviewLysergic acid diethylamideSynaptic densityClinical studiesSynaptophysin 1PRISMA guidelinesSynapsin 1Use disordersPlace preferenceAbuse liabilitySynaptic changesKetaminePSD-95Study designSafety, tolerability, and clinical and neural effects of single-dose psilocybin in obsessive–compulsive disorder: protocol for a randomized, double-blind, placebo-controlled, non-crossover trial
Ching T, Grazioplene R, Bohner C, Kichuk S, DePalmer G, D’Amico E, Eilbott J, Jankovsky A, Burke M, Hokanson J, Martins B, Witherow C, Patel P, Amoroso L, Schaer H, Pittenger C, Kelmendi B. Safety, tolerability, and clinical and neural effects of single-dose psilocybin in obsessive–compulsive disorder: protocol for a randomized, double-blind, placebo-controlled, non-crossover trial. Frontiers In Psychiatry 2023, 14: 1178529. PMID: 37181888, PMCID: PMC10166878, DOI: 10.3389/fpsyt.2023.1178529.Peer-Reviewed Original ResearchObsessive-compulsive disorderPrimary endpointPsilocybin effectsNeural effectsRefractory obsessive-compulsive disorderNon-crossover designOpen-label doseStandard care treatmentOpen-label studyVisual analog scale ratingsTreatment of OCDEffects of psilocybinOCD symptomsInstitutional review boardYale-Brown ObsessivePrimary outcomeSingle doseCare treatmentOral psilocybinInformed consentReview boardNeurobiological mechanismsCompulsive ScalePsychological supportTrialsMethylone, a rapid acting entactogen with robust anxiolytic and antidepressant-like activity
Warner-Schmidt J, Pittenger C, Stogniew M, Mandell B, Olmstead S, Kelmendi B. Methylone, a rapid acting entactogen with robust anxiolytic and antidepressant-like activity. Frontiers In Psychiatry 2023, 13: 1041277. PMID: 36704743, PMCID: PMC9873307, DOI: 10.3389/fpsyt.2022.1041277.Peer-Reviewed Original ResearchForced Swim TestAntidepressant-like effectsMajor depressive disorderPost-traumatic stress disorderSingle doseAnxiolytic effectsSelective serotonin reuptake inhibitor antidepressantsFirst-line pharmacological treatmentSerotonin reuptake inhibitor antidepressantsAntidepressant-like responsePhase 1 studyDoses of fluoxetineReuptake inhibitor antidepressantsAntidepressant-like activityInitial clinical findingsClinical case seriesOnset of actionDurability of effectMale Sprague-DawleyDose-response relationshipSSRI fluoxetineMost patientsSSRI treatmentInhibitor antidepressantsCase series
2022
An HPA-1a–positive platelet–depleting agent for prevention of fetal and neonatal alloimmune thrombocytopenia: a randomized, single-blind, placebo–controlled, single-center, phase 1/2 proof-of-concept study
Geisen C, Kjaer M, Fleck E, Skogen B, Armstrong R, Behrens F, Bhagwagar Z, Braeuninger S, Mortberg A, Olsen K, Gastón Schäfer S, Walter C, Seifried E, Wikman A, Kjeldsen-Kragh J, Koehm M. An HPA-1a–positive platelet–depleting agent for prevention of fetal and neonatal alloimmune thrombocytopenia: a randomized, single-blind, placebo–controlled, single-center, phase 1/2 proof-of-concept study. Journal Of Thrombosis And Haemostasis 2022, 21: 838-849. PMID: 36696185, DOI: 10.1016/j.jtha.2022.11.041.Peer-Reviewed Original ResearchConceptsFetal/Neonatal Alloimmune ThrombocytopeniaNeonatal alloimmune thrombocytopeniaHPA-1aAlloimmune thrombocytopeniaHuman platelet antigen 1aTreatment-emergent adverse eventsPlacebo 1 hourHPA-1a antibodiesFNAIT casesHyperimmune IgGPrimary endpointAdverse eventsFetus/Healthy menSingle doseAntigen 1aHLA-A2Concept studyCohort 1PlaceboFlow cytometryThrombocytopeniaPlateletsAdministrationWeeksEradication of tumors and development of anti-cancer immunity using STINGa targeted by pHLIP
Moshnikova A, DuPont M, Visca H, Engelman D, Andreev O, Reshetnyak Y. Eradication of tumors and development of anti-cancer immunity using STINGa targeted by pHLIP. Frontiers In Oncology 2022, 12: 1023959. PMID: 36330464, PMCID: PMC9622777, DOI: 10.3389/fonc.2022.1023959.Peer-Reviewed Original ResearchTumor-associated macrophagesCancer-associated fibroblastsSTING agonistsT cellsTumor microenvironmentDendritic cellsCT26 tumorsM2-type tumor-associated macrophagesAnti-cancer immunityTumor-free miceEradication of tumorsActivation of cytokinesNovel STING agonistSuppressor cellsSingle doseImmune cellsIntratumoral hemorrhageTherapeutic effectTumor stromaImmune memoryNude miceAdditional injectionTumorsCancer cellsMiceTopical formulation based on disease-specific nanoparticles for single-dose cure of psoriasis
Mai Y, Ouyang Y, Yu M, Qin Y, Girardi M, Saltzman WM, Cocco E, Zhao C, Yu L, Jia Y, Xiao L, Dou L, Deng W, Liu Y, Xie J, Deng Y. Topical formulation based on disease-specific nanoparticles for single-dose cure of psoriasis. Journal Of Controlled Release 2022, 349: 354-366. PMID: 35817278, DOI: 10.1016/j.jconrel.2022.07.006.Peer-Reviewed Original ResearchConceptsHealthy skinPsoriasis treatmentTopical formulationsPsoriatic skinCurrent psoriasis treatmentsFirst-line treatmentSingle-dose cureLocal drug concentrationModerate psoriasisLesional skinSingle doseDermal atrophyTherapeutic levelsTherapeutic efficacyCorticosteroidsDrug concentrationsPsoriasisBNPBasal cellsSkin retentionSkinLesionsBioadhesive nanoparticlesTreatmentStratum corneumPlasmodium falciparum coinfection is associated with improved IgE and IgG3 response against hookworm antigens
Sakyi SA, Wilson MD, Adu B, Opoku S, Brewoo A, Larbi A, Baafour EK, Tchum SK, Saahene RO, Aniagyei W, Sewor C, Courtin D, Cappello M, Gyan B, Amoani B. Plasmodium falciparum coinfection is associated with improved IgE and IgG3 response against hookworm antigens. Health Science Reports 2022, 5: e672. PMID: 35734341, PMCID: PMC9195015, DOI: 10.1002/hsr2.672.Peer-Reviewed Original ResearchL3 stage larvaeAlbendazole treatmentHookworm infectionImmune responseNonendemic controlsPlasmodium falciparum coinfectionsIron deficiency anemiaHookworm treatmentVaccine effectivenessIgG3 responsesIgG responsesAntibody profileSingle doseDeficiency anemiaIgG3 antibodiesBlood samplesIgEProtein malnutritionControl groupVaccine developmentHigh levelsSerum samplesIgG3Stage larvaeInfectionSTING agonist delivery by tumour-penetrating PEG-lipid nanodiscs primes robust anticancer immunity
Dane E, Belessiotis-Richards A, Backlund C, Wang J, Hidaka K, Milling L, Bhagchandani S, Melo M, Wu S, Li N, Donahue N, Ni K, Ma L, Okaniwa M, Stevens M, Alexander-Katz A, Irvine D. STING agonist delivery by tumour-penetrating PEG-lipid nanodiscs primes robust anticancer immunity. Nature Materials 2022, 21: 710-720. PMID: 35606429, PMCID: PMC9156412, DOI: 10.1038/s41563-022-01251-z.Peer-Reviewed Original ResearchConceptsSTING agonistsRobust T cell activationInnate immune stimulatorsT cell activationTumor rechallengeAnticancer immunityDendritic cellsAgonist deliverySingle doseCyclic dinucleotidesTumor antigensImmune stimulatorImmune memorySolid tumorsEnhanced immunotherapySystemic deliveryTumorsTumor cellsCancer cellsAgonistsImmunityDeliveryCellsActivationCleavable linker
2021
Brain target occupancy of LY3372689, an inhibitor of the O‐GlcNAcase (OGA) enzyme, following administration of single and multiple doses to healthy volunteers
Kielbasa W, Shcherbinin S, Goldsmith P, Phipps K, Biglan K, Mancini M, Russell D, Constantinescu C, Gunn R, Nuthall H, Mergott D, Lowe S, Collins E. Brain target occupancy of LY3372689, an inhibitor of the O‐GlcNAcase (OGA) enzyme, following administration of single and multiple doses to healthy volunteers. Alzheimer's & Dementia 2021, 17 DOI: 10.1002/alz.057774.Peer-Reviewed Original ResearchHealthy volunteersEnzyme occupancyPET scansSingle doseMultiple-dose clinical studiesPost-dose intervalPositron emission tomography radioligandBaseline PET scanLonger clinical trialsTarget occupancyTau-related diseasesMultiple dosesMultiple dosingClinical trialsPlasma pharmacokineticsClinical studiesEfficacy trialsSD studiesDose selectionTomography radioligandEnzyme inhibitorsPotential treatmentAlzheimer's diseasePET studiesTarget engagement
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