Safety and immunogenicity of the inactivated whole-virus adjuvanted COVID-19 vaccine VLA2001: A randomized, dose escalation, double-blind phase 1/2 clinical trial in healthy adults비활성화된 전체 바이러스 면역증강제 COVID-19 백신 VLA2001의 안전성 및 면역원성: 건강한 성인을 대상으로 한 무작위, 용량 증량, 이중 맹검 1/2상 임상 시험Clinical Trial Published on 2022-09-012022-09-12 Journal: The Journal of Infection [Category] COVID19(2023년), MERS, SARS, 임상, 진단, [키워드] Adjuvanted vaccine binding clinical development clinical trial conducted convalescent sera coronavirus COVID-19 COVID-19 vaccine CpG CpG 1018 dose Dose escalation dose-escalation double-blind evaluate expressing Frequency geometric mean titre GMT groups headache healthy High dose high-dose group highest dose IFN-γ IgG immunogenicity inactivated Inactivated vaccine injection Local medium N protein neutralizing antibody Open-label optimal dose outcome participant Phase 3 primary immunogenicity priming Randomized randomized trial RBD-binding IgG RBD-binding IgG antibody reactive recruited Registered reported S protein S protein binding IgG antibody Safety SARS-CoV-2 SARS-CoV-2 neutralizing antibody second vaccination severity significantly significantly higher statistically systemic reaction T-cell tested titre Tolerability vaccination Vaccine VLA2001 was selected Whole-virus vaccine. [DOI] 10.1016/j.jinf.2022.06.009 PMC 바로가기 [Article Type] Clinical Trial
Immunogenicity and safety of a SARS-CoV-2 inactivated vaccine (CoronaVac) co-administered with an inactivated quadrivalent influenza vaccine: A randomized, open-label, controlled study in healthy adults aged 18 to 59 years in China비활성화된 4가 인플루엔자 백신과 함께 투여된 SARS-CoV-2 비활성화된 백신(CoronaVac)의 면역원성 및 안전성: 중국에서 18세에서 59세 사이의 건강한 성인을 대상으로 한 무작위, 공개, 대조 연구Randomized Controlled Trial Published on 2022-08-262022-09-12 Journal: Vaccine [Category] COVID19(2023년), MERS, SARS, 임상, 진단, [키워드] 95% confidence interval administration Adverse reaction antibody assigned China comparable Concomitant Concomitant administration conducted CoronaVac COVID-19 COVID-19 vaccine dose enrolled Evidence feasible first dose GMT groups healthy immune response immunogenicity inactivated Inactivated vaccine Influenza influenza vaccine Mild moderate MOST non-inferiority Occurrence Open-label participant per-protocol randomization Randomized Randomly receive regimen SARS-CoV-2 Seasonal influenza second dose seroconversion rate two-sided Vaccine Zhejiang [DOI] 10.1016/j.vaccine.2022.07.021 PMC 바로가기 [Article Type] Randomized Controlled Trial
Immunogenicity and safety of an inactivated SARS-CoV-2 vaccine (Sinopharm BBIBP-CorV) coadministered with quadrivalent split-virion inactivated influenza vaccine and 23-valent pneumococcal polysaccharide vaccine in China: A multicentre, non-inferiority, open-label, randomised, controlled, phase 4 trial중국에서 4가 스플릿-비리온 비활성화 인플루엔자 백신 및 23가 폐렴구균 다당류 백신과 함께 투여된 비활성화 SARS-CoV-2 백신(Sinopharm BBIBP-CorV)의 면역원성 및 안전성: 다기관, 비열등성, 공개 라벨, 무작위, 통제, 4상 시험Clinical Trial Published on 2022-08-262022-09-12 Journal: Vaccine [Category] COVID19(2023년), MERS, SARS, 임상, 진단, [키워드] 23-valent pneumococcal polysaccharide vaccine Administered antibody assigned BBIBP-CorV block randomization blood sample China Coadministration Community dose eligible GMC GMT GMT ratio had no IgG antibody immunogenicity inactivated Inactivated SARS-CoV-2 vaccine individual Influenza Influenza virus multicentre non-inferiority Open-label participant per-protocol population pneumococcal Pneumonia polysaccharide polysaccharide vaccine randomised randomised controlled trial Randomly recruited Registered Safe SARS-CoV-2 SARS-CoV-2 neutralising antibody SARS-CoV-2 vaccine seroconversion rate serotypes Sinopharm Split-virion inactivated influenza vaccine. strain stratified Streptococcus pneumoniae the SARS-CoV-2 three group Trial vaccination Vaccine vaccine group [DOI] 10.1016/j.vaccine.2022.07.033 PMC 바로가기 [Article Type] Clinical Trial
Neutralization of Severe Acute Respiratory Syndrome Coronavirus 2 Omicron Variant by Sera From BNT162b2 or CoronaVac Vaccine RecipientsBNT162b2 또는 CoronaVac 백신 수혜자의 혈청에 의한 중증 급성 호흡기 증후군 코로나바이러스 2 오미크론 변이체의 중화Article Published on 2022-08-242022-09-11 Journal: Clinical Infectious Diseases: An Official Publicat [Category] SARS, 변종, 진단, 치료기술, [키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Antibody titer Antibody titers Beta Beta variant beta variants BNT162b2 CoronaVac coronavirus coronavirus 2 coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 vaccine Delta variants detectable Effectiveness elicited evade genome sequence geometric geometric mean GISAID database GMT GMTs Health Organization isolate Lineage Live virus microneutralization Mutation Nanopore nanopore sequencing neutralization Neutralizing Neutralizing antibodies neutralizing antibody Neutralizing antibody titer no significant difference not affect of BNT162b2 omicron Omicron variant Patient recipient recipients respiratory risk Risk assessment SARS-CoV-2 Sequencing sera severe acute respiratory syndrome Coronavirus significant difference significantly lower spike mutation strain Strains susceptibility TMPRSS2 Vaccine Vaccines variant variant of concern VeroE6 cells virus was determined whole genome sequence World Health Organization [DOI] 10.1093/cid/ciab1041 PMC 바로가기 [Article Type] Article
Safety and Immunogenicity of a Recombinant Adenovirus Type-5-Vectored Coronavirus Disease 2019 (COVID-19) Vaccine With a Homologous Prime-Boost Regimen in Healthy Participants Aged ≥6 Years: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Trial6세 이상의 건강한 참가자를 대상으로 한 상동 프라임-부스트 요법을 사용한 재조합 아데노바이러스 5형 벡터 코로나바이러스 질병 2019(COVID-19) 백신의 안전성 및 면역원성: 무작위, 이중 맹검, 위약 대조, 2b상 시험Randomized Controlled Trial Published on 2022-08-242022-09-11 Journal: Clinical Infectious Diseases: An Official Publicat [Category] 임상, 진단, 치료기술, [키워드] Ad5-vectored COVID-19 vaccine Adenovirus adenovirus type-5-vectored COVID-19 vaccine Adults Adverse adverse events antibody Antibody Response boost children clinical Cohort coronavirus disease Coronavirus disease 2019 COVID-19 COVID-19 vaccine dose double-blind elicited ELISA enrolled enzyme enzyme-linked immunosorbent assay event geometric mean geometric mean titer geometric mean titers GMT GMTs healthy homologous homologous prime immune response immune responses immunogenicity increasing age MIN neutralizing antibody participant phase phase 2b trial. Placebo placebo-controlled trial prime-boost regimen pseudovirus neutralizing antibody Randomized RBD receiving Receptor binding domain recombinant recombinant adenovirus robust Safe Safety SARS-CoV-2 single dose tolerable Trial vaccination Vaccine Viral viral particle [DOI] 10.1093/cid/ciab845 PMC 바로가기 [Article Type] Randomized Controlled Trial
Neutralizing Antibody Response to Pseudotype Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Differs Between mRNA-1273 and BNT162b2 Coronavirus Disease 2019 (COVID-19) Vaccines and by History of SARS-CoV-2 Infection유사형 중증 급성 호흡기 증후군 코로나바이러스 2(SARS-CoV-2)에 대한 중화 항체 반응은 mRNA-1273과 BNT162b2 코로나바이러스 질병 2019(COVID-19) 백신과 SARS-CoV-2 감염의 역사에 따라 다릅니다.Article Published on 2022-08-242022-09-12 Journal: Clinical Infectious Diseases: An Official Publicat [Category] SARS, 진단, [키워드] 19 2 95% confidence interval Antibody titer BNT162b2 BNT162b2 vaccine calculated coronavirus 2 CoV COVID COVID-19 Dilution dose geometric mean GMT GMTs highest history increase Infection inhibitory linear mixed-effects models mRNA mRNA COVID-19 vaccine mRNA vaccine mRNA-1273 mRNA-1273 vaccine NAb Neutralizing antibodies neutralizing antibody participant participants with SARS-CoV-2 prospective cohort pseudotype virus receiving respiratory response SARS SARS-CoV-2 SARS-COV-2 infection sera single dose Symptoms T Test tested uninfected participant uninfected participants vaccination Vaccine vaccine dose was collected [DOI] 10.1093/cid/ciab1038 PMC 바로가기 [Article Type] Article
Safety and immunogenicity following a homologous booster dose of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373): a secondary analysis of a randomised, placebo-controlled, phase 2 trialClinical Trial Published on 2022-08-102022-10-06 Journal: The Lancet. Infectious Diseases [Category] SARS, 변종, 진단, [키워드] 1:1 Administered administration adverse event adverse events age amplifying analysed Analysis antibody concentration Antigen assigned available data BMI booster booster dose Breastfeeding Coalition Contraception COVID-19 pandemic diagnosis of COVID-19 dose Efficacy enrolled evaluated event Evidence exclusion geometric mean titre GMT group healthy homologous IgG immune response inactive increase in initial intramuscular Local Matrix-M median Medical conditions Novavax NVX-CoV2373 outcome participant per-protocol per-protocol population phase 2 trial phase 3 study Placebo placebo-controlled pregnant primary endpoint proportion Protein randomisation randomised Randomly reaction reactogenicity receive Recombinant spike protein recruited regimens Registered Safety SARS-CoV SARS-CoV-2 SARS-CoV-2 strain SARS-CoV-2 vaccine SARS-CoV-2 variant screened serum IgG single booster dose stratified Support the SARS-CoV-2 the vaccine titres Treatment Trial USA vaccination Vaccine variant were excluded women [DOI] 10.1016/S1473-3099(22)00420-0 PMC 바로가기 [Article Type] Clinical Trial
Systemic autoimmune myopathies: a prospective phase 4 controlled trial of an inactivated virus vaccine against SARS-CoV-2전신 자가면역 근병증: SARS-CoV-2에 대한 비활성화된 바이러스 백신의 전향적 4상 대조 시험Clinical Trial Published on 2022-08-032022-09-12 Journal: Rheumatology (Oxford, England) [Category] SARS, 임상, 진단, [키워드] 95%CI adverse event age All participant anti-SARS-CoV-2 anti-SARS-CoV-2 vaccine Autoimmune baseline Comorbidity comparable control group Controlled trial CoronaVac COVID-19 CTRL disease disease status dose drug evaluate Frequency geometric mean titre GMT HIV/AIDS IgG immune response immunogenicity immunogenicity analysis Immunosuppression in both group inactivated interquartile range IQR less median Mild moderate Myopathy myositis Neutralizing Neutralizing activity Neutralizing antibodies neutralizing antibody parameters participant Patient positive pre-vaccination protocol reduced RT-PCR S1/S2 Safe Safety SAM SARS-CoV-2 SARS-CoV-2 vaccine second dose Seroconversion serology Sex significantly lower systemic therapy Type Vaccine vaccine dose virus were excluded [DOI] 10.1093/rheumatology/keab773 PMC 바로가기 [Article Type] Clinical Trial
Safety and immunogenicity of heterologous boost immunisation with an orally administered aerosolised Ad5-nCoV after two-dose priming with an inactivated SARS-CoV-2 vaccine in Chinese adults: a randomised, open-label, single-centre trialRandomized Controlled Trial Published on 2022-08-012022-10-05 Journal: The Lancet. Respiratory Medicine [Category] COVID19(2023년), SARS, 임상, [키워드] 95% CI Adenovirus Administered Adverse reaction agency assigned boost booster dose booster vaccination Booster vaccine China Chinese Controlled trial CoronaVac COVID-19 vaccine development dose evaluate foundation geometric mean titre GMT GMTs Health Heterologous High dose homologous homologous or heterologous immunogenic inactivated incidence individual infection with SARS-CoV-2 intramuscular vaccination Jiangsu Laboratory less live SARS-CoV-2 low dose NAbs natural neutralising antibody Open-label participant primary endpoint priming Program randomised Randomly receive Registered reported Safe Safety SARS-CoV-2 SARS-CoV-2 vaccine Science serum significantly significantly higher Trial vaccination viral particle virus waning immunity [DOI] 10.1016/S2213-2600(22)00087-X PMC 바로가기 [Article Type] Randomized Controlled Trial
Use of heated tobacco products, moderate alcohol drinking, and anti-SARS-CoV-2 IgG antibody titers after BNT162b2 vaccination among Japanese healthcare workers일본 의료 종사자의 BNT162b2 예방 접종 후 가열 담배 제품, 적당한 음주 및 항 SARS-CoV-2 IgG 항체 역가 사용Article Published on 2022-08-012022-09-12 Journal: Preventive medicine [Category] MERS, 진단, [키워드] addition alcohol alcohol consumption Analysis anti-SARS-CoV-2 anti-SARS-CoV-2 IgG antibody Antibody titer association BNT162b2 BNT162b2 vaccine collected coronavirus disease covariates COVID-19 COVID-19 vaccine enzyme geometric mean titer GMT group healthcare worker Heated tobacco products IgG antibody titer immunoassay immunogenicity Immunological response Japan Japanese Linear regression model moderate National participant predictor questionnaire receiving reduction Research Result second vaccination serum significantly lower smoker smoking spike IgG the median vaccination Vaccine vaccine dose were assessed were measured were used [DOI] 10.1016/j.ypmed.2022.107123 PMC 바로가기 [Article Type] Article