Phase 3 – Page 3 – Communicable Diseases Research

Antibody and T cell responses to COVID-19 vaccination in patients receiving anticancer therapies

항암치료를 받는 환자의 코로나19 백신접종에 대한 항체 및 T세포 반응

Article

Published on 2022-06-012022-09-11
Journal: Journal for immunotherapy of cancer [Category] COVID19(2023년), MERS, SARS, 바이오마커, 변종, 진단, 치료기술, 치료제,

Immune response to SARS-CoV-2 after a booster of mRNA-1273: an open-label phase 2 trial

mRNA-1273 부스터 후 SARS-CoV-2에 대한 면역 반응: 공개 표지 2상 시험

Clinical 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

An overview on inactivated and live-attenuated SARS-CoV-2 vaccines

불활성화 및 약독화 SARS-CoV-2 백신에 대한 개요

Review

Published on 2022-05-012022-09-11
Journal: Journal of Clinical Laboratory Analysis [Category] COVID19(2023년), SARS, 치료기술,

[키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 adverse effects antigenic attenuated vaccine benefit Bharat Cell culture Cellular immune response China clinical trials component components coronavirus coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 vaccine deaths effective Efficiency Features followed by Health Organization humoral Humoral and cellular immune responses immune responses inactivated Inactivated vaccine Infection landscape Phase 3 produced producing Record report review Safe SARS-CoV-2 SARS-CoV-2 vaccine severe acute respiratory syndrome Coronavirus similarity Sinopharm Sinovac storage the vaccine Transport trials Vaccine vaccine candidate vaccine platform Vaccines virion virus particle WHO World Health Organization worldwide pandemic Wuhan
[DOI] 10.1002/jcla.24418 PMC 바로가기 [Article Type] Review

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 study

건강한 성인에서 AS03 보조제 SARS-CoV-2 재조합 단백질 백신(CoV2 preS dTM)의 안전성 및 면역원성: 2상, 무작위, 용량 찾기, 다기관 연구의 중간 결과

Clinical 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

Digital remote monitoring plus usual care versus usual care in patients treated with oral anticancer agents: the randomized phase 3 CAPRI trial

Research

Published on 2022-04-252022-10-05
Journal: Nature Medicine [Category] 임상,

Efficacy, safety, and immunogenicity of the DNA SARS-CoV-2 vaccine (ZyCoV-D): the interim efficacy results of a phase 3, randomised, double-blind, placebo-controlled study in India

Clinical Trial

Published on 2022-04-022022-10-05
Journal: Lancet (London, England) [Category] COVID19(2023년), SARS, 임상,

[키워드] 1:1 95% CI Administered adverse event Analysis assessment assigned baseline Biotechnology clinical clinical trial comorbid conditions conducted COVID-19 criteria Cutoff death Department DNA dose double-blind Efficacy efficacy analysis eligible enrolled Government of India Gujarat identify immunogenic India individual injection interim analysis investigators multicentre Occurrence Older outcome assessor participant per-protocol population Phase 3 phase 3 trial Placebo placebo group placebo-controlled placebo-controlled study Primary outcome randomisation randomised Randomly receive Registered registry reported Safe safety population SARS-CoV-2 SARS-CoV-2 vaccine screened symptomatic the placebo group Tolerability Treatment treatment group Trial Vaccine was done was used
[DOI] 10.1016/S0140-6736(22)00151-9 PMC 바로가기 [Article Type] Clinical Trial

Efficacy and safety of baricitinib plus standard of care for the treatment of critically ill hospitalised adults with COVID-19 on invasive mechanical ventilation or extracorporeal membrane oxygenation: an exploratory, randomised, placebo-controlled trial

Clinical Trial

Published on 2022-04-012022-10-04
Journal: The Lancet. Respiratory Medicine [Category] COVID19(2023년), SARS, 임상, 치료법,

[키워드] 1:1 A significant reduction all-cause mortality assigned Baricitinib baseline Blood clots Brazil cardiovascular event Care Cohort Combination company conducted Corticosteroids Critically ill death died double-blind duration of hospitalisation Efficacy efficacy analysis Efficacy and safety Endpoint enrolled evaluate event exploratory extracorporeal membrane oxygenation hazard ratio hospital hospitalised hospitalised patient infections inhibitor intention-to-treat population Invasive mechanical ventilation investigator Janus kinase laboratory-confirmed SARS-CoV-2 infection less Lilly membrane Mortality not differ participant Participants Patient Phase 3 phase 3 trial Placebo placebo-controlled trial placebo-treated participant prevented randomised Randomly receiving reduced reduction Registered risk reduction safety analysis safety population SARS-COV-2 infection selective severely ill patient shown significantly significantly shorter Standard Standard of care Study design study group study population systemic corticosteroid the placebo group Time to recovery Treatment treatment group treatment groups Trial USA ventilator-free day Ventilator-free days was done with COVID-19
[DOI] 10.1016/S2213-2600(22)00006-6 PMC 바로가기 [Article Type] Clinical Trial

Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S

단일 용량 Ad26.COV2.S의 효능 및 안전성에 대한 최종 분석

Clinical Trial

Published on 2022-03-032022-09-11
Journal: The New England Journal of Medicine [Category] COVID19(2023년), SARS, 변종, 임상,

[키워드] 1:1 95% CI 95% confidence interval acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Ad26 Ad26.COV2.S Ad26.COV2.S vaccine administration adverse events Alpha Analysis assigned B.1.1.7 B.1.617.2 B.1.621 caused conducted coronavirus coronavirus disease Coronavirus disease 2019 COV2.S COVID-19-related death death development double-blind effective Efficacy efficacy analysis end point exploratory Final final analysis Follow-up Hospitalization Infection janssen medical intervention Mild-to-moderate moderate moderate to severe P.1 participant Participants per-protocol population Phase 3 Placebo placebo group placebo-controlled trial primary end point protection provided Randomized receive reference strain research and development Safety SARS-CoV-2 severe COVID-19 single dose the placebo group The United States the vaccine United States Vaccine vaccine efficacy vaccine group variant variants Viral particles was reduced
[DOI] 10.1056/NEJMoa2117608 PMC 바로가기 [Article Type] Clinical Trial

Lenzilumab in hospitalised patients with COVID-19 pneumonia (LIVE-AIR): a phase 3, randomised, placebo-controlled trial

입원한 COVID-19 폐렴 환자에 대한 렌질루맙(LIVE-AIR): 3상, 무작위, 위약 대조 시험

Clinical Trial

Published on 2022-03-012022-09-12
Journal: The Lancet. Respiratory Medicine [Category] Fulltext, SARS, 임상, 진단,

[키워드] 1:1 95% CI added Administered Adverse adverse event age assigned baseline Brazil C-reactive protein concentration cardiac disorder contribute Corticosteroids COVID-19 criteria CTCAE cytokine death demographics disease severity dose double-blind Efficacy and safety enrolled event GM-CSF granulocyte-macrophage colony-stimulating factor greater groups hazard ratio hospitalised hospitalised patient hyperinflammation Immune-mediated immunomodulator include Inflammatory intention-to-treat population intravenous dose Invasive mechanical ventilation investigated investigator IQR likelihood males median mITT mITT analysis modified intention-to-treat monoclonal antibody neutralising participant pathophysiology Patient patients with COVID-19 Phase 3 Placebo placebo-controlled trial Pneumonia primary endpoint Primary outcome randomisation randomised Randomly receive recruited Registered Remdesivir respiratory disorder Respiratory failure safety profile screened severity significantly standard supportive care steroid stratified study drug survival the placebo group treat treating COVID-19 treatment-emergent adverse event Trial USA were assessed with COVID-19
[DOI] 10.1016/S2213-2600(21)00494-X PMC 바로가기 [Article Type] Clinical Trial

Efficacy and safety of the BNT162b2 mRNA COVID-19 vaccine in participants with a history of cancer: subgroup analysis of a global phase 3 randomized clinical trial

Clinical Trial

Published on 2022-03-012022-10-05
Journal: Vaccine [Category] SARS, 임상,

[키워드] AEs baseline BNT162b2 BNT162b2 mRNA BNT162b2 vaccine Cancer clinical clinical trials COVID-19 COVID-19 pandemic COVID-19 vaccine death Efficacy Efficacy and safety excluded fatigue Follow-up follow-up time high risk Hospitalization immunosuppressive incidence rate individual Infection Injection-site pain malignancy Melanoma MOST neoplasm Neoplasms observer-blinded outcomes participant Participants Phase 3 Placebo placebo recipient placebo-controlled Prostate Pyrexia Randomized randomized clinical trial reactogenicity event receiving reported Safe Safety subgroup analysis therapy Trial unblinding Vaccine were excluded
[DOI] 10.1016/j.vaccine.2021.12.046 PMC 바로가기 [Article Type] Clinical Trial