A multitope SARS-CoV-2 vaccine provides long-lasting B cell and T cell immunity against Delta and Omicron variants멀티토프 SARS-CoV-2 백신은 Delta 및 Omicron 변이체에 대해 오래 지속되는 B 세포 및 T 세포 면역을 제공합니다Clinical Trial Published on 2022-05-162022-09-11 Journal: The Journal of Clinical Investigation [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, 치료기술, 치료법, [키워드] adverse event Antibody titers Asia B cell booster Breakthrough infection breakthrough infections center conducted conserved Control COVID-19 cross-reactive cytotoxic T lymphocyte Delta disease control dose elicited epitope Epitopes evaluated fatigue healthy helper T cell Heterologous human convalescent sera Immunity immunization immunogenicity Inc. injection site pain long-lasting lymphocyte membrane memory immunity Mild Ministry of Health Neutralizing antibodies Neutralizing antibody titer neutralizing antibody titers Neutralizing titer nucleocapsid omicron Omicron variants peptide peptides Phase I placebo-controlled Protein provide Randomized representing responsible safety profile sarbecovirus SARS-CoV-2 vaccine SARS-CoV-2 variant SARS-CoV-2 variants second dose Serious Adverse Event Serious Adverse Events subunit Subunit vaccine T cell Taiwan Trial trials Vaccine variant variants of SARS-CoV-2 virus-neutralizing antibody VOCs waning immunity Welfare were recorded [DOI] 10.1172/JCI157707 PMC 바로가기 [Article Type] Clinical Trial
Repair of acute respiratory distress syndrome by stromal cell administration (REALIST): a structured study protocol for an open-label dose-escalation phase 1 trial followed by a randomised, triple-blind, allocation concealed, placebo-controlled phase 2 trial간질 세포 투여에 의한 급성 호흡 곤란 증후군의 회복(REALIST): 공개 라벨 용량 증량 1상 시험에 이어 무작위, 삼중 맹검, 할당 은폐, 위약 대조 2상 시험을 위한 구조화된 연구 프로토콜Article Published on 2022-05-132022-09-11 Journal: Trials [Category] COVID19(2023년), SARS, 임상, [키워드] 1:1 acute respiratory distress acute respiratory distress syndrome administration allocation ARDS benefit blind causes Cell cells clinical clinical trial Cohort cohort of patient cohorts of patients concealed CONSORT COVID-19 distress dose dose-escalation early stage early stages Efficacy EudraCT Good immunomodulatory incidence include Mesenchymal stem cells Mesenchymal stromal cell Mesenchymal stromal cells moderate to severe MSC MSCs multicentre NHS number Open-label outcome outlined oxygenation index patients patients with moderate Phase 1 phase 1 trial Phase 2 phase 2 trial Placebo placebo-controlled placebo-controlled trial Practice produced protocol randomised rationale receive recruited recruitment repair reported Reporting respiratory distress Respiratory distress syndrome Serious Adverse Events severe ARDS Standard stromal cell stromal cells Study protocol syndrome therapy Trial triple-blind umbilical Umbilical cord [DOI] 10.1186/s13063-022-06220-0 PMC 바로가기 [Article Type] Article
A phase 2 randomized, double-blinded, placebo-controlled, multicenter trial evaluating the efficacy and safety of raloxifene for patients with mild to moderate COVID-19Research article Published on 2022-05-122022-10-05 Journal: EClinicalMedicine [Category] 신약개발, 임상, [키워드] Action acute respiratory syndrome adaptive clinical testing consumer coronavirus disease-2019 Coronavirus-2 COVID COVID-19 COVID-19 disease current decrease doses double-blinded Effect Efficacy and safety Emergency Endpoint enrolled Estrogen European Commission evaluate Evidence finding FIVE funding hospitalized patients immunomodulator indications instrument Italian Italy lack mechanical ventilation Medicine Mild Ministry of Health mitigate moderate Moderate COVID-19 modulate multicenter Multicenter trial Nasopharyngeal swab Occurrence participant Patient pharmacological Phase 2 study Placebo placebo-controlled placebo-controlled trial Prevent Primary outcome progression proinflammatory cytokines proportion raloxifene Randomized receive Registered Replication reported Safety safety profile SARS-CoV-2 Selective estrogen receptor modulator (SERM) Serious Adverse Events Seven supplemental oxygen Supplemental oxygen therapy Support supported therapeutic option treat Treatment Trial undetectable viral shedding [DOI] 10.1016/j.eclinm.2022.101450 [Article Type] Research article
Evaluation of mRNA-1273 Covid-19 Vaccine in Children 6 to 11 Years of Age6~11세 어린이의 mRNA-1273 Covid-19 백신 평가Clinical Trial Published on 2022-05-112022-09-25 Journal: The New England Journal of Medicine [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, 치료법, [키워드] 95% CI 95% confidence interval acute respiratory syndrome Administered Adults age Analysis assigned authority B.1.617.2 children circulating coronavirus coronavirus disease criterion development dominant dose effective Efficacy Estimated events fatigue groups headache immune response incidence Infection Inflammatory injection Injection-site pain Interim interquartile range median mRNA-1273 mRNA-1273 vaccine myocarditis Neutralizing antibody titer observer-blinded open label Part participant phase 2–3 trial phase 3 trial Placebo placebo-controlled Prevent public health Randomly receive reported response Result Safe Secondary objective selected Serious Adverse Events Serologic response Symptoms syndrome the vaccine transient adverse Trial Vaccine variant was selected Year [DOI] 10.1056/NEJMoa2203315 PMC 바로가기 [Article Type] Clinical Trial
Dynamic of anti-spike receptor binding domain (RBD) levels and short-term adverse events following a heterologous booster dose of BNT162b2 after two doses of CoronaVac in Thai health care workers태국 의료 종사자에게 코로나백 2회 투여 후 BNT162b2의 이종 부스터 투여 후 항스파이크 수용체 결합 도메인(RBD) 수준 및 단기 부작용의 역학Article Published on 2022-05-092022-09-11 Journal: Vaccine [Category] COVID19(2023년), MERS, SARS, 변종, 진단, [키워드] (Abbott) Abbott Administered Adverse adverse event anti-RBD anti-SARS-CoV-2 IgG anti-SARS-CoV-2 IgG antibodies anti-SARS-CoV-2 IgG antibody Anti-spike Anti-spike receptor binding domain antibody Architect average being BNT162b2 booster booster dose booster vaccination completion conducted CoronaVac COVID COVID mRNA vaccine COVID-19 COVID-19 vaccine dose dynamic evaluate female HCW HCWs Health care Health care worker Heterologous hospital humoral immune response IgG antibodies IgG antibody immunogenicity log median median age mRNA of BNT162b2 participant Participants promoted RBD receive Receptor binding Receptor binding domain resulting SARS-CoV-2 IgG Serious Adverse Events severe adverse effect Side effect significantly the epidemic variants was determined were assessed [DOI] 10.1016/j.vaccine.2022.04.020 PMC 바로가기 [Article Type] Article
Safety and immunogenicity of an AS03-adjuvanted SARS-CoV-2 recombinant protein vaccine (CoV2 preS dTM) in healthy adults: interim findings from a phase 2, randomised, dose-finding, multicentre study건강한 성인에서 AS03 보조제 SARS-CoV-2 재조합 단백질 백신(CoV2 preS dTM)의 안전성 및 면역원성: 2상, 무작위, 용량 찾기, 다기관 연구의 중간 결과Clinical Trial Published on 2022-05-012022-09-11 Journal: The Lancet. Infectious Diseases [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, [키워드] 95% CI abstinence adjuvants Adults adverse event adverse events Adverse reaction Adverse reactions age All participant All participants antibody Antibody titre Antigen AS03 assessments assigned authority baseline booster vaccination candidate vaccine Chemotherapy childbearing potential clinical development Clinical research clinical trial Cohort Contraception COVID-19 vaccine D614G variant development dose effective Endpoint enrolled evaluated expected fixed Frequency geometric mean geometric mean titre GMT GMT ratio GMTs groups healthy High dose High-dose high-dose group Immunocompromised immunogenicity increase in increased risk injection injection site Injections intensity interim results investigator investigators involved Laboratory lactating low dose low-dose medical condition Medical conditions medium medium dose Mild mild to moderate moderate multicentre Neutralising Antibodies neutralising antibody neutralising antibody titre neutralising antibody titres occurred Older Older adults Organ transplant outcome outcome assessor outcome assessors parallel-group participant Participants Phase 2 Phase 3 positive prefusion pregnant primary immunogenicity progression proportion Protein protocol provided pseudovirus neutralisation assay randomised Randomly reactogenicity receive Registered reported Research research and development responses robust Safety safety analysis safety endpoints safety profile Sanofi Pasteur SARS-CoV-2 second dose second vaccination selected Serious Adverse Event Serious Adverse Events serodiagnostic Seven severe COVID-19 Stratification study period supported systemic test result titre titres Treatment treatment group treatment groups Trial USA vaccination Vaccine was done were excluded were measured yes or no [DOI] 10.1016/S1473-3099(21)00764-7 PMC 바로가기 [Article Type] Clinical Trial
Efficacy and safety of tocilizumab versus standard care/placebo in patients with COVID-19; a systematic review and meta-analysis of randomized clinical trialsCOVID-19 환자에서 표준 치료/위약 대비 토실리주맙의 효능 및 안전성 무작위 임상 시험의 체계적인 검토 및 메타 분석Review Published on 2022-05-012022-09-11 Journal: British Journal of Clinical Pharmacology [Category] COVID19(2023년), SARS, 임상, 진단, [키워드] 95% CI adverse event all-cause mortality assessment Bia carried certainty certainty of evidence clinical trial controlled trials coronavirus coronavirus disease COVID-19 COVID-19 patient Critical data extraction Efficacy Efficacy and safety evaluate evaluated event events incidence include mechanical ventilation Meta-analysis methodology moderate Mortality nine Patient patients with COVID-19 peer-reviewed progression Randomized randomized clinical trial Randomized controlled trial RCT RCTs reduce reported responsible risk Risk of bias risk ratio SAE searched Serious Adverse Events systematic review therapy Tocilizumab tocilizumab administration variety [DOI] 10.1111/bcp.15124 PMC 바로가기 [Article Type] Review
Efficacy and safety of two neutralising monoclonal antibody therapies, sotrovimab and BRII-196 plus BRII-198, for adults hospitalised with COVID-19 (TICO): a randomised controlled trialCOVID-19(TICO)로 입원한 성인을 위한 두 가지 중화 단일클론항체 치료제인 소트로비맙과 BRII-196과 BRII-198의 효능 및 안전성: 무작위 대조 시험Randomized Controlled Trial Published on 2022-05-012022-09-12 Journal: The Lancet. Infectious Diseases [Category] COVID19(2023년), SARS, 임상, 진단, [키워드] addition adjusted adjusted odds ratio Administered analyses Analysis assigned Biotechnology Clinical outcome clinical recovery clinical trial Complication complications of COVID-19 COVID-19 COVID-19 symptom death defined Denmark died discharge double-blind Efficacy Efficacy and safety eligible enrolled enrolment female hospital hospitalised Inpatient Interim intravenously laboratory-confirmed SARS-CoV-2 infection male matching placebo median age modified intention-to-treat monoclonal antibody neutralising operation Organ failure outcome participant Patient Placebo placebo group placebo-controlled Poland Primary outcome randomisation randomised randomised controlled trial Randomly recruited Registered Serious Adverse Events significantly higher single dose speed Standard of care stratified study drug sustained Switzerland the placebo group Therapeutics Therapies therapy Treatment Trial USA were assessed with COVID-19 [DOI] 10.1016/S1473-3099(21)00751-9 PMC 바로가기 [Article Type] Randomized Controlled Trial
Immunogenicity and safety of a SARS-CoV-2 recombinant spike protein nanoparticle vaccine in people living with and without HIV-1 infection: a randomised, controlled, phase 2A/2B trialHIV-1 감염 여부에 관계없이 살고 있는 사람들을 대상으로 한 SARS-CoV-2 재조합 스파이크 단백질 나노입자 백신의 면역원성과 안전성: 무작위, 대조, 2A/2B상 시험Clinical Trial Published on 2022-05-012022-09-12 Journal: The Lancet. HIV [Category] COVID19(2023년), MERS, SARS, 임상, 진단, [키워드] 1:1 amplification angiotensin-converting enzyme 2 anti-Spike IgG antibody Antiretroviral therapy article assigned baseline clinical Coalition Cohort COVID-19 COVID-19 vaccine death dosage Efficacy and safety ELISA endpoints enrolled enrolment evaluated first vaccination geometric mean titre GMT GMTs HIV-1 HIV-1 viral HIV-negative humoral immune response immunogenicity increased risk individual injection interim analysis intervention group Intramuscular injection less Local Matrix-M Melinda Gate multicentre neutralising antibody titres Novavax NVX-CoV2373 NVX-CoV2373 vaccine observer-blinded occurred PACTR202009726132275 participant Participants paucity of data Placebo placebo-controlled provided randomised Randomly reactive receive Recombinant spike protein Registered registry remained reported safety analysis SARS-CoV-2 SARS-CoV-2 nucleic acid SCR SCRs second vaccination Serious Adverse Event Serious Adverse Events seroconversion rate serostatus South Africa stratified study group Support systemic adverse event the placebo group the vaccine Trial vaccination Vaccine vaccine immunogenicity Volume was used were assessed [DOI] 10.1016/S2352-3018(22)00041-8 PMC 바로가기 [Article Type] Clinical Trial
Immune response to SARS-CoV-2 after a booster of mRNA-1273: an open-label phase 2 trialmRNA-1273 부스터 후 SARS-CoV-2에 대한 면역 반응: 공개 표지 2상 시험Clinical Trial Published on 2022-05-012022-09-11 Journal: Nature Medicine [Category] COVID19(2023년), MERS, SARS, 변종, 임상, 진단, 치료기술, [키워드] 95% CI 95% confidence interval acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Adverse reactions anti-Spike IgG antibody Antibody titer Antibody titers B.1.617.2 booster booster dose booster injection Booster vaccine Breakthrough infection caused Cell coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 criterion delta variant disease dose Effectiveness elicited ELISA evaluated exploratory follow-up period Frequency immunized immunogenicity individual Infection injection Local memory B memory B cell Meso Scale Discovery mRNA mRNA-1273 MSD NAb NAb titers neutralizing antibody non-inferiority non-randomized Open-label participant Phase 2 phase 2 trial Phase 3 primary immunogenicity raised reported respiratory Safe SARS-CoV-2 second dose Serious Adverse Event Serious Adverse Events severe acute respiratory syndrome Coronavirus significantly higher statistically systemic adverse reaction systemic adverse reactions titers vaccination Vaccine variants wild-type SARS-CoV-2 [DOI] 10.1038/s41591-022-01739-w PMC 바로가기 [Article Type] Clinical Trial