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
Editorial: First Approval of the Protein-Based Adjuvanted Nuvaxovid (NVX-CoV2373) Novavax Vaccine for SARS-CoV-2 Could Increase Vaccine Uptake and Provide Immune Protection from Viral Variants사설: SARS-CoV-2에 대한 단백질 기반 보조제 Nuvaxovid(NVX-CoV2373) Novavax 백신의 첫 번째 승인은 백신 흡수를 증가시키고 바이러스 변이체로부터 면역 보호를 제공할 수 있음Editorial Published on 2022-03-012022-09-11 Journal: Medical science monitor : international medical jo [Category] SARS, 변종, 신약개발, [키워드] approval component editorial elicit EMA epitope Epitopes European European Commission European Medicines Agency full-length S protein Great Britain Healthcare Products Regulatory Agency immune response immune responses increase individual Matrix-M Medicine Medicines MHRA Novavax NVX-CoV2373 product PROTECT protection Protein recommendation S protein SARS-CoV-2 shelf life temperature the S protein the SARS-CoV-2 the vaccine union uptake Vaccine Viral variants [DOI] 10.12659/MSM.936523 PMC 바로가기 [Article Type] Editorial
Calibrated comparison of SARS-CoV-2 neutralizing antibody levels in response to protein-, mRNA-, and vector-based COVID-19 vaccinesBrief Communication Published on 2022-02-182022-10-04 Journal: NPJ Vaccines [Category] 임상, [키워드] calibrated COVID-19 vaccine COVID-19 vaccines Drug development Efficacy elicited International mRNA neutralizing antibody Neutralizing antibody response NVX-CoV2373 Protein SARS-CoV-2 antibody SARS-CoV-2 neutralizing antibody suggested Support the SARS-CoV-2 the WHO Vaccines [DOI] 10.1038/s41541-022-00455-3 PMC 바로가기 [Article Type] Brief Communication
Prediction of long-term kinetics of vaccine-elicited neutralizing antibody and time-varying vaccine-specific efficacy against the SARS-CoV-2 Delta variant by clinical endpoint임상 종말점에 의한 SARS-COV-2 델타 변이체에 대한 백신 유발 중화 항체 및 시변 백신-특이 적 효능의 장기 동역학 예측Research Article Published on 2022-01-282022-09-01 Journal: BMC Medicine [Category] SARS, 변종, 진단, [키워드] 95% CI administration age antibody BNT162b2 caused Clinical severity CoronaVac COVID-19 pandemic COVID-19 vaccines decrease delta variant dose doses Efficacy Endpoint evaluate FIVE homologous Inactivated Vaccines Infection marker mRNA mRNA vaccine mRNA vaccines mRNA-1273 neutralization neutralization titer neutralizing antibody NVX-CoV2373 predict predicted prediction Prevent Protein responses Result SARS-CoV-2 SARS-CoV-2 Delta variants second dose severe COVID-19 supplementary material Surveillance symptomatic the SARS-CoV-2 Time-varying efficacy titers vaccination Vaccine variants [DOI] 10.1186/s12916-022-02249-9 PMC 바로가기 [Article Type] Research Article
Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial영국에서 2 가지 용량의 Chadox1 NCOV-19 또는 BNT162B2에 따른 3 가지 용량 (부스터)으로서 7 개의 코비드 -19 백신의 안전성 및 면역 원성Clinical Trial Published on 2021-12-182022-08-13 Journal: Lancet (London, England) [Category] Fulltext, SARS, 임상, [키워드] 95% CI Ad26 Ad26.COV2.S adverse event age anti-Spike IgG antibody assigned blinded BNT BNT162b2 booster booster vaccination booster vaccines cellular response Cellular responses ChAd ChAdOx1 ChAdOx1 nCoV-19 Control control group control groups Course COV-BOOST COVID-19 COVID-19 vaccine CureVac CVn CVnCoV dose eligibility criteria ELISA female finding FIVE funding generate geometric mean geometric mean ratio geometric mean ratios GMR GMRs group humoral Humoral and cellular responses immunogenicity individuals initial intention-to-treat population investigated IQR ISRCTN janssen laboratory-confirmed SARS-CoV-2 infection Local m1273 median age MenACWY meningococcal conjugate vaccine Moderna modified intention-to-treat mRNA1273 multicentre neutralising response neutralising responses Novavax NVX NVX-CoV2373 Older Older age outcome Pain participant Participants Pfizer Phase 2 phase 2 trial primary analysis quadrivalent meningococcal conjugate vaccine randomised Randomly ranged reactogenicity referred to Registered Safety SARS-COV-2 infection screened secondary Secondary outcomes Serious Adverse Events Seven spike IgG systemic adverse events the median three group three groups treat treatment allocation Trial Vaccine vaccine availability Valneva Viral viral neutralisation VLA2001 were assessed were blinded white wild-type [DOI] 10.1016/S0140-6736(21)02717-3 PMC 바로가기 [Article Type] Clinical Trial
Efficacy and Safety of NVX-CoV2373 in Adults in the United States and MexicoClinical Trial Published on 2021-12-152022-10-04 Journal: The New England Journal of Medicine [Category] COVID19(2023년), MERS, SARS, 변종, 비임상, 임상, [키워드] 95% CI 95% confidence interval acute respiratory syndrome age Alpha assigned B.1.1.7 caused Clinical efficacy conducted coronavirus coronavirus disease determine disease dose effective Efficacy Efficacy and safety evaluate first dose Genome Infection median age Mild moderate MOST North America Novavax NVX-CoV2373 NVX-CoV2373 recipient observer-blinded occurred over participant Phase 3 Placebo placebo recipient placebo recipients placebo-controlled trial randomization Randomized Randomly receive recipient Recombinant spike protein Result Safe Safety SARS-CoV-2 second dose sequenced Severe case shown South Africa Strains tested the United State Trial United Kingdom Vaccine vaccine efficacy variant variants of concern viral genome yielding [DOI] 10.1056/NEJMoa2116185 PMC 바로가기 [Article Type] Clinical Trial
Different dose regimens of a SARS-CoV-2 recombinant spike protein vaccine (NVX-CoV2373) in younger and older adults: A phase 2 randomized placebo-controlled trial청소년 및 노인의 SARS-COV-2 재조합 스파이크 단백질 백신 (NVX-COV2373)의 상이한 용량 요법 : 2 상 무작위 위약 대조 시험Clinical Trial Published on 2021-10-012022-08-13 Journal: PLoS Medicine [Category] Biochemistry, MERS, SARS, 임상, 진단, [키워드] 95% CI 95% confidence interval accumulate addition Administered Adults adverse events age Anti-spike Antibody Response assessments assigned composed conducted convalescent sera coronavirus Day dose dose regimen Efficacy Endpoint Enrollment exceeded Follow-up Formica Frequency full-length SARS-CoV-2 geometric mean geometric mean titer geometric mean titers GMTs group groups identify IgG immune persistence immune response immune responses immunogenic immunogenicity Immunoglobulin Immunoglobulin G include inhibitory concentration intensity intramuscular dose lack limitation Matrix-M1 adjuvant median Mild mild to moderate moderate neutralizing antibody Neutralizing antibody response neutralizing antibody responses NVX-CoV2373 occurred less Older Older adults participant Participants Phase 1 Phase 2 Placebo placebo-controlled placebo-controlled trial primary endpoints Protein Randomized randomized placebo-controlled trial Randomly reactogenicity receive Recombinant spike protein regimen researcher respiratory Respiratory Coronavirus robust safety follow-up SARS-CoV-2 second dose second vaccination secondary endpoint seroconversion rate seroconversion rates severity short duration spike glycoprotein spike glycoproteins Spike protein Support The United States These data Tolerability Treatment Trial Trial registration trimeric United States USA vaccination Vaccine vaccine group wild-type virus [DOI] 10.1371/journal.pmed.1003769 PMC 바로가기 [Article Type] Clinical Trial
Safety and Efficacy of NVX-CoV2373 Covid-19 VaccineNVX-CoV2373 Covid-19 백신의 안전성 및 효능Clinical Trial Published on 2021-06-302022-09-25 Journal: The New England Journal of Medicine [Category] MERS, SARS, 변종, 신약개발, 임상, 진단, [키워드] 1:1 95% CI 95% confidence interval acute respiratory syndrome Administered age Alpha Analysis assigned B.1.1.7 B.1.1.7 variant baseline Clinical data conducted coronavirus death dose Efficacy efficacy end point EudraCT full-length spike glycoprotein generally mild healthy Hospitalization illnesses immune response incidence Infection injection intramuscular Matrix-M Mild moderate Novavax NVX-CoV2373 NVX-CoV2373 vaccine observer-blinded Older participant Participants per-protocol Phase 3 Placebo placebo-controlled trial randomization Randomized receive reported Result robust Safe Safety SARS-CoV-2 SARS-COV-2 infection Serious Adverse Event Serologically Severe infection severe SARS-CoV-2 symptom onset the placebo group the vaccine two groups two-dose regimen United Kingdom Vaccine variant variants [DOI] 10.1056/NEJMoa2107659 PMC 바로가기 [Article Type] Clinical Trial
Efficacy of the NVX-CoV2373 Covid-19 Vaccine Against the B.1.351 VariantB.1.351 변이체에 대한 NVX-CoV2373 Covid-19 백신의 효능Clinical Trial Published on 2021-05-202022-08-13 Journal: The New England Journal of Medicine [Category] Fulltext, SARS, 변종, 임상, 진단, [키워드] 1:1 95% CI 95% confidence interval acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 Administered Against B.1.351 B.1.351 variant baseline baseline serostatus both groups coronavirus COVID-19 pandemic dosed doses Efficacy healthy HIV-negative Human immunodeficiency virus immunodeficiency virus in both groups laboratory-confirmed Matrix-M1 adjuvant Mild mild to moderate moderate multicenter not differ NVX-CoV2373 NVX-CoV2373 nanoparticle vaccine NVX-CoV2373 vaccine observer observer-blinded pandemic participant Participants Placebo placebo recipients placebo-controlled trial PLWH Preliminary local primary endpoint primary endpoints Randomized receive Recombinant spike protein respiratory Result SARS-CoV-2 SARS-CoV-2 variant SARS-CoV-2 variants second dose sequenced Serious Adverse Event Serious Adverse Events seronegative participant seropositive serostatus severe acute respiratory syndrome Coronavirus South Africa Spike protein symptomatic COVID-19 systemic reactogenicity uninfected participants Vaccine Vaccine development vaccine efficacy variant variants with HIV [DOI] 10.1056/NEJMoa2103055 PMC 바로가기 [Article Type] Clinical Trial
The Perception and Attitudes toward COVID-19 Vaccines: A Cross-Sectional Study in PolandArticle Published on 2021-04-142022-10-28 Journal: Vaccines [Category] COVID-19, [키워드] Ad26.COV2.S age Allergic reactions approach approved Attitude AZD1222 BNT162b BNT162b2 clinical trials conducted contrary COVID-19 COVID-19 vaccination COVID-19 vaccine cross-sectional CureVac Effect effective eight European expressing highest inactivated individual information Live attenuated vaccines median Moderna mRNA platform mRNA vaccine mRNA vaccines mRNA-1273 Novavax NVX-CoV2373 pandemic participant Perception Poland POLE produced receive risk SARS-CoV-2 seeking severe adverse event Stage union vaccination vaccination against COVID-19 Vaccinations Vaccine Vaccine hesitancy Vaccines vector vaccines [DOI] 10.3390/vaccines9040382 PMC 바로가기 [Article Type] Article