Safety of COVID-19 vaccines in patients with non-communicable diseases: a protocol for systematic review and meta-analysis of randomised controlled trials의사 소통 할 수없는 질병 환자의 Covid-19 백신의 안전성 : 체계적인 검토 및 무작위 대조 시험의 메타 분석을위한 프로토콜Article Published on 2022-05-242022-08-31 Journal: BMJ Open [Category] COVID19(2023년), MERS, meta-analysis, SARS, 임상, [키워드] Adverse adverse event adverse events Adverse reaction Adverse reactions Affect analysed approval best carried caused Cochrane Library conducted COVID-19 COVID-19 pandemic COVID-19 vaccine Data analysis data extraction dose Ethical approval Ethics event Evidence global pandemic heterogeneity identify item Local Meta-analysis Non-communicable disease non-communicable diseases not limited outcome Participation Patient peer-reviewed Primary outcome Primary outcomes PROSPERO protocol public health randomised controlled trial Randomised controlled trials RCT RCTs Registered registration number Reporting researchers resolved review risk of bia Safety Selection significantly systematic review systemic adverse event therapeutic strategy threat Trial trials vaccination Vaccine Vaccines Web of Science Withdrawal [DOI] 10.1136/bmjopen-2021-057233 PMC 바로가기 [Article Type] Article
Clinical Effectiveness of Regdanvimab Treatment for Mild-to-Moderate COVID-19: A Retrospective Cohort StudyResearch article Published on 2022-05-162022-10-05 Journal: Current Therapeutic Research [Category] 신약개발, 임상, 치료법, [키워드] Adverse reaction Clin clinical coronavirus disease COVID-19 CT-P59 death deaths Deterioration discharged efficacy end point Exp Fever Hospitalization indicate mechanical ventilation median time Mild-to-moderate oxygen oxygen saturation p value Patient patients deteriorating patients with COVID-19 performed peripheral capillary phase Placebo Prevent proportion reduced regdanvimab Remdesivir required Result retrospective cohort study Retrospective study risk SARS-CoV-2 single hospital SOC Standard of care sustained treated Two patient [DOI] 10.1016/j.curtheres.2022.100675 [Article Type] Research article
COVID-19 Vaccine-Induced Multisystem Inflammatory Syndrome With Polyserositis Detected by FDG PET/CTFDG PET/CT로 검출된 다발성 장막염을 동반한 코로나19 백신 유발 다계통 염증 증후군Case Reports Published on 2022-05-012022-09-11 Journal: Clinical nuclear medicine [Category] COVID19(2023년), SARS, 치료기술, [키워드] administration Adverse reaction BNT162b2 BNT162b2 mRNA C-reactive protein condition Corticosteroids COVID-19 COVID-19 vaccination COVID-19 vaccine COVID-19 vaccines elevated evaluate FDG Fever High-dose Immune-mediated infiltration Inflammatory Pericarditis pericardium Peritoneum peritonitis PET/CT Polyserositis Prolonged fever reported resolved serum serum C-reactive protein Symptom syndrome systemic inflammation systemic symptom the patient Treatment [DOI] 10.1097/RLU.0000000000004094 PMC 바로가기 [Article Type] Case Reports
Adverse events following COVID-19 vaccination in South Korea between February 28 and August 21, 2021: A nationwide observational studyObservational Study Published on 2022-05-012022-10-04 Journal: International Journal of Infectious Diseases [Category] COVID19(2023년), SARS, 유전자 메커니즘, 임상, [키워드] Adverse adverse event adverse events Adverse reaction AEs age all age groups analyzed AZD1222 BNT162b2 caution Characteristics Clinical characteristics Clinical symptoms complications conducted Control COVID-19 COVID-19 vaccination COVID-19 vaccines dose epidemiological event first dose Frequency individual JNJ-78436735 Korean Mild Mortality MOST mRNA-1273 occurred Occurrence Patient Pfizer-BioNTech prevention Reactions reported Research SARS-CoV-2 severe AE severity South Korea study period vaccination Vaccine vaccine reactions were assessed [DOI] 10.1016/j.ijid.2022.03.007 PMC 바로가기 [Article Type] Observational Study
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
Applying lessons learned from nanomedicines to understand rare hypersensitivity reactions to mRNA-based SARS-CoV-2 vaccines Reviews Published on 2022-04-072022-10-05 Journal: Nature nanotechnology [Category] COVID19(2023년), SARS, 바이오마커, 유전자 메커니즘, 치료제, [키워드] adverse events Adverse reaction affected anaphylaxis Applying approach contribute Factor hypersensitivity hypersensitivity reaction immunization include individual knowledge manifestation mechanism mRNA mRNA vaccine mRNA vaccines mRNA-based SARS-CoV-2 vaccine nanomedicine nanomedicines predicted Predictive reaction recipient recommendation repeated Research risk Safe SARS-CoV-2 vaccines second dose Symptom the SARS-CoV-2 vaccination Vaccine viral variant viruses [DOI] 10.1038/s41565-022-01071-x [Article Type] Reviews
Effectiveness and Safety of Regdanvimab in Patients With Mild-To-Moderate COVID-19: A Retrospective Cohort Study경증에서 중등도의 COVID-19 환자에서 Regdanvimab의 효과 및 안전성: 후향적 코호트 연구Article Published on 2022-04-042022-09-12 Journal: Journal of Korean medical science [Category] 진단, [키워드] 1:1 95% CI 95% confidence interval Administered Adverse reaction Adverse reactions Analysis analyzed antibody center clinical recovery Cohort conducted coronavirus disease COVID-19 death disease Effect Effectiveness groups hematological high-flow oxygen therapy Hospital stay In-hospital death indicated information mechanical ventilation Mild Mild-to-moderate Moderate COVID-19 monoclonal need for oxygen Odds ratio outcome Oxygen therapy Patient patients patients treated phase 2/3 Primary outcome Randomized controlled trial reached reduced regdanvimab risk Safety secondary outcome selected significantly significantly lower therapy treated [DOI] 10.3346/jkms.2022.37.e102 PMC 바로가기 [Article Type] Article
Inactivated Whole-virus Vaccine Triggers Low Response Against SARS-CoV-2 Infection Among Renal Transplant Patients: Prospective Phase 4 Study Results비활성화된 전체 바이러스 백신은 신장 이식 환자에서 SARS-CoV-2 감염에 대한 낮은 반응을 유발합니다: 예상 4상 연구 결과Clinical Trial Published on 2022-04-012022-09-11 Journal: Transplantation [Category] COVID19(2023년), SARS, 임상, 진단, 치료기술, [키워드] A significant reduction acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Adverse reaction Adverse reactions Against Analysis antibody Antibody Response Antibody responses clinical effectiveness Cohort CoronaVac coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 death elicit first dose humoral Humoral response IgG antibodies IgG antibody inactivated incidence of COVID-19 increase individual intramuscular dose kidney transplant recipients lack lethality rate lethality rates mRNA vaccine Neutralizing antibodies occurred Patient patients phase 4 proportion Prospective Prospective trial reactogenicity recipient recipients reduced reduction in remained reported respiratory response Result SARS-CoV-2 second dose Severe acute respiratory syndrome severe acute respiratory syndrome Coronavirus single-center solid-organ transplant Transplant transplantation Trigger vaccination vaccination schedule Vaccine [DOI] 10.1097/TP.0000000000004036 PMC 바로가기 [Article Type] Clinical Trial
Immunogenicity and safety of a third dose of CoronaVac, and immune persistence of a two-dose schedule, in healthy adults: interim results from two single-centre, double-blind, randomised, placebo-controlled phase 2 clinical trials건강한 성인에서 코로나백 3차 접종의 면역원성 및 안전성, 2회 접종 일정의 면역 지속성: 2건의 단일 센터, 이중 맹검, 무작위, 위약 대조 임상 2상 임상 시험의 중간 결과Clinical Trial Published on 2022-04-012022-09-12 Journal: The Lancet. Infectious Diseases [Category] COVID19(2023년), SARS, 임상, 진단, [키워드] 1:1 95% CI Abstract Administered Adverse reaction analysed antibody Antibody titre assigned Beijing booster dose China clinical trial clinical trials Cohort cohorts Concentration CoronaVac country Cutoff declined development dose doses double-blind eligible foundation GenBank accession number generate geometric geometric mean titre GMIs GMT GMTs groups healthy immune memory immune persistence immune response immunogenicity Inactivated vaccine increase increase in injection Jiangsu material natural neutralising antibody neutralising antibody titre Older outcome participant per-protocol population phase 2 trial Placebo placebo group placebo-controlled positive Program protocol amendment randomised Randomly recalled receive Registered reported resulting SARS-CoV-2 Science second dose Serious Adverse Event seropositive severity significantly increased technology threshold translation Trial vaccination vaccination against COVID-19 vaccination schedule Vaccine virus strain [DOI] 10.1016/S1473-3099(21)00681-2 PMC 바로가기 [Article Type] Clinical Trial
Safety and immunogenicity of inactivated COVID-19 vaccine in health care workers의료 종사자에서 비활성화된 COVID-19 백신의 안전성 및 면역원성Article Published on 2022-04-012022-09-11 Journal: Journal of medical virology [Category] COVID19(2023년), MERS, SARS, 진단, 치료법, [키워드] administration adverse event Adverse reaction Adverse reactions age antibodies antibody Antibody Response Antibody responses appear booster doses comparable Concentration conducted convalescent plasma convalescent serum CoronaVac coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 vaccine domain dose Effective vaccines geometric mean geometric mean concentration GMC Health care Health care worker health care workers hospital IgG immunization immunogenicity Immunoglobulin Immunoglobulin G inactivated Inactivated vaccine incidence Infection injection Injection-site pain Local myalgia N protein nucleocapsid nucleocapsid protein Pain pandemic participant positive prospective cohort study Protein RBD Receptor-binding domain recruited regimen Safe Safety SARS-CoV-2 Serious Adverse Event Serious Adverse Events seroconversion rate seroconversion rates Spike protein tested the RBD Total total antibodies total antibody U/mL Vaccine virus waned [DOI] 10.1002/jmv.27458 PMC 바로가기 [Article Type] Article