intramuscular dose – Communicable Diseases Research

Immunogenicity and reactogenicity of an inactivated SARS-CoV-2 vaccine (BBV152) in children aged 2-18 years: interim data from an open-label, non-randomised, age de-escalation phase 2/3 study

Clinical Trial

Published on 2022-09-012022-10-05
Journal: The Lancet. Infectious Diseases
[Category] COVID19(2023년), SARS, 임상, 진단,

Safety and immunogenicity of the ChAdOx1 nCoV-19 (AZD1222) vaccine in children aged 6-17 years: a preliminary report of COV006, a phase 2 single-blind, randomised, controlled trial

6~17세 어린이 대상 ChAdOx1 nCoV-19(AZD1222) 백신의 안전성 및 면역원성: 2상 단일 맹검, 무작위, 대조 시험인 COV006의 예비 보고서

Clinical Trial

Published on 2022-06-112022-09-11
Journal: Lancet (London, England)
[Category] COVID19(2023년), MERS, SARS, 임상, 진단, 치료법,

[키워드] 95% CI administration Adults adverse event adverse events age All participants anti-SARS-CoV-2 IgG antibody Antibody titre antibody titres arbitrary unit assigned AstraZeneca AZD1222 baseline capsular Cellular responses ChAdOx1 ChAdOx1 nCoV-19 children chronic respiratory conditions Concentration Controlled trial COVID-19 COVID-19 vaccine COVID-19 vaccines Cutoff Department dose doses Efficacy enrolled Fever first dose first vaccination four group four groups geometric geometric mean geometric mean ratios Geometric means group half-maximal inhibitory concentration Humoral response humoral responses immune response immune responses immunogenic immunogenicity in some intramuscular dose introduced investigators ISRCTN Laboratory laboratory-confirmed Laboratory-confirmed COVID-19 Local nucleocapsid protein Pain and tenderness participant Participants peaked Phase 2 phase 3 study preliminary report Primary outcome prime and boost raised randomised Randomly receive receiving recruitment Registered remained reported resolved respiratory response Safety safety population SARS-CoV-2 second dose second vaccination secondary outcome Serious Adverse Event Serious Adverse Events seronegative seronegative participant seronegative participants seropositive serostatus single-blind stratified study drug study groups tenderness Tolerability treatment allocation Trial vaccination Vaccine Viral viral particle were recorded
[DOI] 10.1016/S0140-6736(22)00770-X PMC 바로가기 [Article Type] Clinical Trial

Inactivated Whole-virus Vaccine Triggers Low Response Against SARS-CoV-2 Infection Among Renal Transplant Patients: Prospective Phase 4 Study Results

비활성화된 전체 바이러스 백신은 신장 이식 환자에서 SARS-CoV-2 감염에 대한 낮은 반응을 유발합니다: 예상 4상 연구 결과

Clinical 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

Efficacy of the adjuvanted subunit protein COVID-19 vaccine, SCB-2019: a phase 2 and 3 multicentre, double-blind, randomised, placebo-controlled trial

보조제 서브유닛 단백질 COVID-19 백신, SCB-2019의 효능: 2상 및 3상 다기관, 이중 맹검, 무작위 배정, 위약 대조 시험

Clinical Trial

Published on 2022-01-292022-09-11
Journal: Lancet (London, England)
[Category] 변종, 임상,

[키워드] 1:1 95% CI alum assigned baseline Belgium biopharmaceutical Brazil caused chloride circulating Clover Coalition country COVID 19 COVID-19 COVID-19 case COVID-19 vaccine CpG Cutoff dose doses double-blind effective vaccine Effective vaccines Efficacy efficacy analysis elicited Endpoint enrolled EudraCT exclusion FIVE follow-up period groups Health health condition injection injection site pain intramuscular dose Local median Mild-to-moderate moderate-to-severe COVID-19 MOST multicentre notable Older pandemic participant per-protocol per-protocol population Phase 2 Placebo placebo recipients placebo-controlled trial predominant primary endpoints Protein provide randomisation randomised Randomly receive Registered RT-PCR Safe SAR-CoV-2 SARS CoV SARS-CoV-2 SCB-2019 second dose seronegative participant Seropositivity severe COVID-19 severity Sodium chloride South Africa subset subunit systemic adverse event systemic adverse events Vaccine vaccine efficacy vaccinee vaccinees variant virus virus variants viruses was done
[DOI] 10.1016/S0140-6736(22)00055-1 PMC 바로가기 [Article Type] Clinical Trial

Efficacy, safety, and lot-to-lot immunogenicity of an inactivated SARS-CoV-2 vaccine (BBV152): interim results of a randomised, double-blind, controlled, phase 3 trial

Clinical Trial

Published on 2021-12-112022-10-05
Journal: Lancet (London, England)
[Category] Fulltext, MERS, 임상,

[키워드] 1:1 95% CI absence Administered Adults adverse event age Analysis anaphylaxis assigned Bharat chronic conditions clinical Clinical efficacy clinical trial clinically clinics computer-generated Council COVID-19 COVID-19 infection Cutoff deaths dependent on distribution dose double-blind Efficacy evaluate Follow-up groups healthy hospital immunocompromising condition immunological immunosuppressive inactivated India interim analysis intramuscular dose investigators laboratory-confirmed median medical condition multicentre Nurse occurred Occurrence outcome outcomes participant Participants per-protocol population Phase 3 phase 3 trial Placebo placebo group placebo recipients placebo-controlled Primary outcome proportion raised randomisation randomised Randomly reactogenicity receive recipient recruited Registered registry reported Research safety population SARS-CoV-2 vaccine second dose Serious Adverse Event seronegative participant severity significant difference Sponsor stratified study population symptomatic symptomatic COVID-19 disease the vaccine therapy Toll-like receptor Treatment treatment group Trial Vaccine virion
[DOI] 10.1016/S0140-6736(21)02000-6 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 trial

청소년 및 노인의 SARS-COV-2 재조합 스파이크 단백질 백신 (NVX-COV2373)의 상이한 용량 요법 : 2 상 무작위 위약 대조 시험

Clinical 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 immunogenicity of an mRNA-lipid nanoparticle vaccine candidate against SARS-CoV-2 A phase 1 randomized clinical trial

SARS-COV-2에 대한 mRNA- 지질 나노 입자 백신 후보의 안전성 및 면역 원성은 1 상 무작위 임상 시험

Clinical Trial

Published on 2021-08-102022-08-13
Journal: Wiener Klinische Wochenschrift
[Category] MERS, SARS, 임상, 진단,

[키워드] Belgium comparable convalescent sera CureVac CVnCoV CVnCoV dose CVnCoV doses CVnCoV vaccination dosage Dosage-dependent increases Dose-response elicited ELISA enzyme enzyme-linked immunosorbent enzyme-linked immunosorbent assay Escalation Frequency Germany Ghent group Hannover healthy IgG antibodies IgG antibody immune response immune responses immunogenicity increases in interim analysis intramuscular dose Lipid nanoparticle Lipid nanoparticles LNP Local local AEs Mild moderate Munich Neutralizing antibodies overlapped Phase 1 phase 1 study Placebo platform Protein randomized clinical trial RBD reactogenicity Receptor binding domain response Result S protein S‑protein Safe Safety SARS-CoV-2 SARS-CoV‑2 SARS-CoV‑2 neutralizing titer SARS-CoV‑2 neutralizing titers SARS-CoV‑2 S‑protein second dose sequence-optimized mRNA coding serious AEs seroconverted severity supplementary material systemic adverse event systemic adverse events systemic AEs Tübingen vaccination Vaccine vaccine candidate Volunteer was measured
[DOI] 10.1007/s00508-021-01922-y PMC 바로가기 [Article Type] Clinical Trial

Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial

비활성화된 SARS-CoV-2 백신, BBV152의 안전성 및 면역원성: 이중 맹검, 무작위, 다기관, 2상 시험 및 이중 맹검, 무작위 1상 시험의 3개월 추적 조사의 중간 결과

Clinical Trial

Published on 2021-07-012022-09-12
Journal: The Lancet. Infectious Diseases
[Category] Fulltext, SARS, 임상, 진단,

[키워드] 1:1 95% CI Abstract addition Administered Antigen assigned baseline Bharat block blood draw cell-mediated immune response clinical trial collected defined dose double-blind Efficacy elevated elicited enrolled evaluate first dose Follow-up geometric mean GMT healthy high neutralising antibody Hindi hospital humoral inactivated India intramuscular dose investigators Local material microneutralisation test MNT multicentre neutralisation test neutralising antibody titre nine outcomes participant phase 1 trial Phase 2 study phase 2 trial Phase 3 positive Primary outcome PRNT proportion randomisation randomised Randomly reactogenicity receive Registered remained reported response Safety SARS-CoV-2 SARS-CoV-2 nucleic acid SARS-CoV-2 vaccine screened second dose second vaccination secondary outcome selected Serious Adverse Event seroconversion rate serology test significant difference significantly higher Sponsor T-cell Response Th1 phenotype the vaccine titre Toll-like receptor translation treatment group Trial Vaccine was done were assessed were excluded wild-type
[DOI] 10.1016/S1473-3099(21)00070-0 PMC 바로가기 [Article Type] Clinical Trial

Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19

COVID-19에 대한 식물 유래 바이러스 유사 입자 백신의 1상 무작위 시험

Clinical Trial

Published on 2021-05-182022-10-27
Journal: Nature Medicine
[Category] COVID-19,

[키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 adjuvants adverse event adverse events AS03 AS03 or CpG1018 Canada cellular response Cellular responses convalescent sera coronavirus COVID-19 CoVLP CoVLP + AS03 CoVLP vaccine CpG1018 Day dose Dose escalation Efficacy generally mild group groups highest Human immunogenicity immunogenicity assessment immunogenicity assessments immunogenicity data include interferon interim analysis interleukin intramuscular dose mild to moderate moderate NAb NAbs neutralizing antibody observer-blinded outcome Phase 1 plant plants populations produced Quebec, Canada Randomized randomized controlled study randomized trial receive required respiratory Safety SARS-CoV-2 SARS-CoV-2 spike glycoprotein SARS-CoV-2 vaccine second dose secondary Secondary outcomes serum serum NAbs short-term tolerability/safety significantly spike glycoprotein spike protein-specific interferon-γ supply Support the SARS-CoV-2 titers vaccination Vaccine virus-like particle vaccine
PMC 바로가기 [Article Type] Clinical Trial

Phase 1 randomized trial of a plant-derived virus-like particle vaccine for COVID-19

COVID-19에 대한 식물 유래 바이러스 유사 입자 백신의 1상 무작위 시험

Clinical Trial

Published on 2021-05-182022-08-13
Journal: Nature Medicine
[Category] MERS, SARS, 임상, 진단, 치료기술, 치료법,

[키워드] acute respiratory syndrome acute respiratory syndrome coronavirus acute respiratory syndrome coronavirus 2 adjuvants adverse event adverse events AS03 AS03 or CpG1018 Canada cellular response Cellular responses convalescent sera coronavirus COVID-19 CoVLP CoVLP + AS03 CoVLP vaccine CpG1018 Day dose Dose escalation Drug development Efficacy generally mild group groups highest Human immunogenicity immunogenicity assessment immunogenicity assessments immunogenicity data include interferon interim analysis interleukin intramuscular dose mild to moderate moderate NAb NAbs neutralizing antibody observer-blinded outcome Phase 1 plant plants populations produced Quebec, Canada Randomized randomized controlled study randomized trial receive required respiratory Safety SARS-CoV-2 SARS-CoV-2 spike glycoprotein SARS-CoV-2 vaccine second dose secondary Secondary outcomes serum serum NAbs short-term tolerability/safety significantly spike glycoprotein spike protein-specific interferon-γ supply Support the SARS-CoV-2 titers Translational research vaccination Vaccine virus-like particle vaccine
[DOI] 10.1038/s41591-021-01370-1 PMC 바로가기 [Article Type] Clinical Trial