SARS-CoV-2 mRNA Vaccine Development Enabled by Prototype Pathogen Preparedness프로토타입 병원체 대비를 통한 SARS-CoV-2 mRNA 백신 개발Article Published on 2020-06-112022-09-11 Journal: bioRxiv [Category] 비임상, [키워드] Betacoronavirus breath CD8 T cell CD8 T cell responses clinical trial COVID-19 development Efficacy Evidence evidence of expressing expression Health crisis immunogenicity immunopathology induce lung Lungs mice mRNA mRNA vaccine mRNA-1273 Mutation neutralizing antibody phase Phase 2 prefusion PROTECT prototype public health crisis response SARS-CoV-2 SARS-COV-2 infection SARS-CoV-2 sequence SARS-CoV-2 sequences SARS-CoV-2 spike trimer SARS-CoV-2 vaccine Spike proteins Structure T cell trajectory triggered [DOI] 10.1101/2020.06.11.145920 PMC 바로가기 [Article Type] Article
Repair of Acute Respiratory Distress Syndrome by Stromal Cell Administration in COVID-19 (REALIST-COVID-19): A structured summary of a study protocol for a randomised, controlled trialLetter Published on 2020-06-032022-10-29 Journal: Trials [Category] Coronavirus, SARS, [키워드] 1:1 active malignancy acute respiratory distress syndrome Administered administration age approval approved ARDS assessment automated Berlin blinded Cell cell suspension cellular changes in chronic liver disease class clinical Clinical diagnosis Clinical outcome clinical outcomes clinical trial comparator Compliance conducted control group Controlled trial COVID 19 COVID-19 COVID-19 pandemic declined defined described determine diagnosis of COVID-19 dissemination Donor Dose escalation driving Effect Efficacy element eligible Elizabeth enrolled ethics committee EudraCT excluded facilitate failure fixed dose hospital ICU incidence Inclusion increase in index individual information infusion intensive care unit Intervention Invasive mechanical ventilation investigator King’s College London London Mesenchymal stem cells Mesenchymal stromal cells MHRA moderate Mortality MSC MSCs NIHR number objective open label Other outcome pandemic PaO participant Patient patient population patients with ARDS PCR test PF ratio Phase 1 Phase 2 Placebo placebo-controlled protocol protocol amendment Public randomised randomised controlled trial REC receiving recruited recruitment repair reported Research respiratory Resuscitation Sample size secondary Secondary objective Secondary outcomes Serious Adverse Events severe ARDS single intravenous infusion SOFA solution Standard steering committee stratified stromal cell Study protocol Therapeutics therapy trauma Treatment Trial triple blinded Trust umbilical United Kingdom university Venous Thromboembolism Ventilation verbal Volume web-based randomisation system website WHO Withdrawal [DOI] 10.1186/s13063-020-04416-w PMC 바로가기 [Article Type] Letter
Anti-SARS-CoV-2 neutralizing monoclonal antibodies: clinical pipelineAnti-SARS-CoV-2 중화 단일클론항체: 임상 파이프라인Article Published on 2020-01-012022-09-11 Journal: mAbs [Category] MERS, SARS, 유전자 메커니즘, 임상, 진단, [키워드] anti-SARS-CoV-2 antibody bamlanivimab BGB-DXP593 candidate clinical trials Convalescent plasma therapy COVID-19 COVID-19 pandemic CT-P59 disease Ebolavirus Efficacy focus GSK4182136 LY-CoV016 LY-CoV555 mAb mAb cocktails mAbs mechanism mechanism of action monoclonal monoclonal antibody Neutralizing ongoing trial ongoing trials phase Phase 2 Pneumonia REGN-CoV2 Research research and development respiratory syncytial virus SARS-CoV-2 therapy VIR-7831 Viral viral infections virus pneumonia while [DOI] 10.1080/19420862.2020.1854149 PMC 바로가기 [Article Type] Article
Gepotidacin for the Treatment of Uncomplicated Urogenital Gonorrhea: A Phase 2, Randomized, Dose-Ranging, Single-Oral Dose Evaluation단순 비뇨 생식기 임질 치료를 위한 게포티다신: 2상, 무작위, 용량 범위, 단일 경구 용량 평가Articles and Commentaries Published on 2018-08-152022-09-07 Journal: Clinical Infectious Diseases: An Official Publicat [Category] Communicable Disease, [키워드] 1:1 95% confidence interval adverse event adverse events Antibiotics Bacterial baseline clinical collected Culture cure demonstrated dose drug-resistant effective Efficacy and safety enrolled evaluated Gender gepotidacin gonorrhea groups highest infections inhibitor inhibitory concentration isolate isolates microbiologically Mutation Neisseria gonorrhoeae New participant Participants pharyngeal Phase 2 Phase 2 study Randomized receive rectal rectal specimens rectal swab Registration specimen stratified susceptibility Swab therapeutic option Treatment urogenital [DOI] 10.1093/cid/ciy145 PMC 바로가기 [Article Type] Articles and Commentaries
Safety and Immunogenicity of Newborn MVA85A Vaccination and Selective, Delayed Bacille Calmette-Guerin for Infants of Human Immunodeficiency Virus-Infected Mothers: A Phase 2 Randomized, Controlled Trial신생아 MVA85A 백신 접종 및 인간 면역결핍 바이러스에 감염된 산모의 유아를 위한 선택적 지연 Bacille Calmette-Guerin의 안전성 및 면역원성: 2상 무작위, 대조 시험Articles and Commentaries Published on 2018-02-152022-09-06 Journal: Clinical Infectious Diseases: An Official Publicat [Category] Communicable Disease, [키워드] acquisition Ag85A age appear ARMS bacille Calmette-Guérin BCG BCG vaccination boost candidate CD4 CD4+ T cell CD4+ T cells CD4+ T-cell clinical control arm Controlled Delayed disease double-blind ENhance enrolled excluded Follow-up followed by functional HIV HIV infection HIV-exposed infants HIV-uninfected Human Human immunodeficiency virus IFNγ immune response immunodeficiency virus immunogenicity Infant interfere interferon gamma life magnitude memory MVA85A New Newborn no significant difference Phase 2 phenotype potential risk profiles PROTECT randomized, controlled trial reactogenicity event Registration response Result Safe Safety selective Serious Adverse Events significantly higher subsequent T cells T-cell Response tested Tuberculosis tuberculosis disease tuberculosis vaccine vaccination Vaccination strategy vaccinees [DOI] 10.1093/cid/cix834 PMC 바로가기 [Article Type] Articles and Commentaries
Resistance characterization of hepatitis C virus genotype 2 from Japanese patients treated with ombitasvir and paritaprevir/ritonavir옴비타스비르와 파리타프레비르/리토나비르로 치료받은 일본인 환자의 C형 간염 바이러스 유전자형 2의 내성 특성 규명Research Article Published on 2017-09-222022-09-06 Journal: Journal of medical virology [Category] Communicable Disease, [키워드] Amino acid analyses Analysis baseline evaluated Genotype genotype 2 HCV hepatitis C virus Infection inhibitor Japanese NS5A occurred ombitasvir ombitasvir/paritaprevir/ritonavir paritaprevir Patient patients patients treated Phase 2 Phase 2 study phase 3 study polymorphism Prevalence regimen resistance ribavirin Ritonavir sequence Substitution substitutions Support Treatment outcome Viral Viral resistance [DOI] 10.1002/jmv.24923 PMC 바로가기 [Article Type] Research Article
Safety and efficacy of the choline analogue SAR97276 for malaria treatment: results of two phase 2, open-label, multicenter trials in African patients말라리아 치료를 위한 콜린 유사체 SAR97276의 안전성 및 유효성: 아프리카 환자를 대상으로 한 두 개의 2상, 공개 라벨, 다기관 시험 결과Research Published on 2017-05-042024-08-12 Journal: Malaria Journal [Category] 말라리아, [키워드] Africa Choline analogue malaria P. falciparum Phase 2 SAR97276A [DOI] 10.1186/s12936-017-1832-x PMC 바로가기 [Article Type] Research
Group B streptococcus vaccination in pregnant women with or without HIV in Africa: a non-randomised phase 2, open-label, multicentre trial아프리카에서 HIV가 있거나 없는 임산부를 대상으로 한 그룹 B 연쇄상구균 백신: 비무작위 2상, 공개 라벨, 다기관 시험Articles Published on 2016-05-012022-09-06 Journal: The Lancet. Infectious Diseases [Category] Communicable Disease, [키워드] (no infection adverse event Adverse reaction Analysis Antenatal antibody antibody concentration Antibody concentrations Birth Blood CD4 cell Cell clinics collected Concentration died disease dose enrolled event finding Fold change Follow-up funding geometric geometric mean gestation GlaxoSmithKline group groups HIV HIV infection HIV-uninfected immunogenic immunogenicity increased risk Infant Infants Infection intramuscularly invasive Italy less life maternal antibody Medical Research Council Meningeal mother multicentre Neonate Neonates no infection Novartis Open-label participant Pathogens Phase 2 placental pregnant women Primary outcome Primary outcomes Protective provided recruited reduce Registered reported respiratory resulting safety analyses serotype-specific serotypes serum serum sample Siena South Africa stillborn the vaccine three group three groups transfer transferred Trial trivalent unit vaccination Vaccine Wellcome Trust were measured with HIV women [DOI] 10.1016/S1473-3099(15)00484-3 PMC 바로가기 [Article Type] Articles
Safety, immunogenicity, and efficacy of the candidate tuberculosis vaccine MVA85A in healthy adults infected with HIV-1: a randomised, placebo-controlled, phase 2 trialHIV-1에 감염된 건강한 성인에서 후보 결핵 백신 MVA85A의 안전성, 면역원성 및 효능: 무작위, 위약 대조, 2상 시험Articles Published on 2015-03-012022-09-06 Journal: The Lancet. Respiratory Medicine [Category] Communicable Disease, [키워드] 1:1 95% CI absence active tuberculosis adverse event Antigen antigen 85A antigen 85A-specific T-cell response antiretroviral Antiretroviral therapy assigned assist baseline baseline CD4 block blocks booster Cape CD4 count CD4 counts Cell clinical defined detect detectable Developing disease double-blind effective Efficacy eligible Eligible participants enrolled enrolment European Evidence evidence of expressing finding first vaccination foundation funding gold greater Group allocation had no healthy HIV-1 HIV-1 infection immunogenic immunogenicity include increased risk Infection injection intradermal injections investigators isoniazid isoniazid prophylaxis Laboratory latent tuberculosis latent tuberculosis infection M tuberculosis Measures Melinda Gate Melinda Gates modified vaccinia virus MVA85A Mycobacterium tuberculosis nine no evidence of Nurses occurred outcome participant partnership peaked per-protocol analysis per-protocol population Phase 2 phase 2 trial Placebo placebo group placebo-controlled positive Potential Prophylaxis protocol QuantiFERON QuantiFERON-TB Gold In-Tube randomisation randomised Randomly receive receiving Registered reported Safe Safety safety analysis second vaccination secondary Secondary outcomes sequence Serious Adverse Event Serious Adverse Events significant increase South Africa stratified subset T-cell Response the placebo group therapy town Treatment Trial Tuberculosis tuberculosis disease tuberculosis vaccine undetectable vaccination Vaccine vaccine efficacy vaccine-induced immune response Viral Viral load Wellcome Trust were assessed [DOI] 10.1016/S2213-2600(15)00037-5 PMC 바로가기 [Article Type] Articles