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10.1056/NEJMoa2103055 http://scihub22266oqcxt.onion/10.1056/NEJMoa2103055 33951374!8091623!33951374     free     free     free Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534 Deprecated: Implicit conversion from float 233.6 to int loses precision in C:\Inetpub\vhosts\kidney.de\httpdocs\pget.php on line 534       N+Engl+J+Med 2021 ; 384 (20): 1899-1909 Nephropedia Template TP {{tp|p=33951374|t=2021. Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B 1 351 Variant |pdf=|usr=}}{{33951374}} gab.com Text Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B 1 351 Variant JO: N Engl J Med http://www.kidney.de/pget.php?&tw=1&pmid=33951374 #FOAvip BACKGROUND: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants threatens progress toward control of the coronavirus disease 2019 (Covid-19) pandemic. In a phase 1-2 trial involving healthy adults, the NVX-CoV2373 nanoparticle vaccine had an acceptable safety profile and was associated with strong neutralizing-antibody and antigen-specific polyfunctional CD4+ T-cell responses. Evaluation of vaccine efficacy was needed in a setting of ongoing SARS-CoV-2 transmission. METHODS: In this phase 2a-b trial in South Africa, we randomly assigned human immunodeficiency virus (HIV)-negative adults between the ages of 18 and 84 years or medically stable HIV-positive participants between the ages of 18 and 64 years in a 1:1 ratio to receive two doses of either the NVX-CoV2373 vaccine (5 mug of recombinant spike protein with 50 mug of Matrix-M1 adjuvant) or placebo. The primary end points were safety and vaccine efficacy against laboratory-confirmed symptomatic Covid-19 at 7 days or more after the second dose among participants without previous SARS-CoV-2 infection. RESULTS: Of 6324 participants who underwent screening, 4387 received at least one injection of vaccine or placebo. Approximately 30% of the participants were seropositive for SARS-CoV-2 at baseline. Among 2684 baseline seronegative participants (94% HIV-negative and 6% HIV-positive), predominantly mild-to-moderate Covid-19 developed in 15 participants in the vaccine group and in 29 in the placebo group (vaccine efficacy, 49.4%; 95% confidence interval [CI], 6.1 to 72.8). Vaccine efficacy among HIV-negative participants was 60.1% (95% CI, 19.9 to 80.1). Of 41 sequenced isolates, 38 (92.7%) were the B.1.351 variant. Post hoc vaccine efficacy against B.1.351 was 51.0% (95% CI, -0.6 to 76.2) among the HIV-negative participants. Preliminary local and systemic reactogenicity events were more common in the vaccine group; serious adverse events were rare in both groups. CONCLUSIONS: The NVX-CoV2373 vaccine was efficacious in preventing Covid-19, with higher vaccine efficacy observed among HIV-negative participants. Most infections were caused by the B.1.351 variant. (Funded by Novavax and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT04533399.). Twit Text FOAVip Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B 1 351 Variant ????N Engl J Med http://www.kidney.de/pget.php?&tw=1&pmid=33951374 #FOAvip Twit Text # Free Paper on # # # # # LINK http://www.kidney.de/pget.php?&tw=1&pmid=33951374 #FOAvip English Wikipedia <ref>{{Cite pmid|33951374}}</ref> Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B 1 351 Variant #MMPMID33951374 Shinde V; Bhikha S; Hoosain Z; Archary M; Bhorat Q; Fairlie L; Lalloo U; Masilela MSL; Moodley D; Hanley S; Fouche L; Louw C; Tameris M; Singh N; Goga A; Dheda K; Grobbelaar C; Kruger G; Carrim-Ganey N; Baillie V; de Oliveira T; Lombard Koen A; Lombaard JJ; Mngqibisa R; Bhorat AE; Benade G; Lalloo N; Pitsi A; Vollgraaff PL; Luabeya A; Esmail A; Petrick FG; Oommen-Jose A; Foulkes S; Ahmed K; Thombrayil A; Fries L; Cloney-Clark S; Zhu M; Bennett C; Albert G; Faust E; Plested JS; Robertson A; Neal S; Cho I; Glenn GM; Dubovsky F; Madhi SA N Engl J Med 2021[May]; 384 (20): 1899-1909 PMID33951374show ga BACKGROUND: The emergence of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) variants threatens progress toward control of the coronavirus disease 2019 (Covid-19) pandemic. In a phase 1-2 trial involving healthy adults, the NVX-CoV2373 nanoparticle vaccine had an acceptable safety profile and was associated with strong neutralizing-antibody and antigen-specific polyfunctional CD4+ T-cell responses. Evaluation of vaccine efficacy was needed in a setting of ongoing SARS-CoV-2 transmission. METHODS: In this phase 2a-b trial in South Africa, we randomly assigned human immunodeficiency virus (HIV)-negative adults between the ages of 18 and 84 years or medically stable HIV-positive participants between the ages of 18 and 64 years in a 1:1 ratio to receive two doses of either the NVX-CoV2373 vaccine (5 mug of recombinant spike protein with 50 mug of Matrix-M1 adjuvant) or placebo. The primary end points were safety and vaccine efficacy against laboratory-confirmed symptomatic Covid-19 at 7 days or more after the second dose among participants without previous SARS-CoV-2 infection. RESULTS: Of 6324 participants who underwent screening, 4387 received at least one injection of vaccine or placebo. Approximately 30% of the participants were seropositive for SARS-CoV-2 at baseline. Among 2684 baseline seronegative participants (94% HIV-negative and 6% HIV-positive), predominantly mild-to-moderate Covid-19 developed in 15 participants in the vaccine group and in 29 in the placebo group (vaccine efficacy, 49.4%; 95% confidence interval [CI], 6.1 to 72.8). Vaccine efficacy among HIV-negative participants was 60.1% (95% CI, 19.9 to 80.1). Of 41 sequenced isolates, 38 (92.7%) were the B.1.351 variant. Post hoc vaccine efficacy against B.1.351 was 51.0% (95% CI, -0.6 to 76.2) among the HIV-negative participants. Preliminary local and systemic reactogenicity events were more common in the vaccine group; serious adverse events were rare in both groups. CONCLUSIONS: The NVX-CoV2373 vaccine was efficacious in preventing Covid-19, with higher vaccine efficacy observed among HIV-negative participants. Most infections were caused by the B.1.351 variant. (Funded by Novavax and the Bill and Melinda Gates Foundation; ClinicalTrials.gov number, NCT04533399.). |*Immunogenicity, Vaccine[MESH] |*SARS-CoV-2/isolation & purification[MESH] |Adolescent[MESH] |Adult[MESH] |Aged[MESH] |Aged, 80 and over[MESH] |Antibodies, Neutralizing/blood[MESH] |COVID-19 Serological Testing[MESH] |COVID-19 Vaccines/adverse effects/*immunology[MESH] |COVID-19/epidemiology/immunology/*prevention & control/virology[MESH] |Double-Blind Method[MESH] |HIV Seronegativity[MESH] |HIV Seropositivity[MESH] |Humans[MESH] |Middle Aged[MESH] |South Africa[MESH]Efficacy of NVX-CoV2373 Covid-19 Vaccine against the B 1 351 Variant (epmc).pdf DeepDyve Pubget Overpricing