Efficacy and Safety of NVX-CoV2373 in Adults in the United States and Mexico
| Autor: | Dunkle, Lisa M, Kotloff, Karen L, Gay, Cynthia L, Áñez, Germán, Adelglass, Jeffrey M, Barrat Hernández, Alejandro Q, Harper, Wayne L, Duncanson, Daniel M, McArthur, Monica A, Florescu, Diana F, McClelland, R Scott, Garcia-Fragoso, Veronica, Riesenberg, Robert A, Musante, David B, Fried, David L, Safirstein, Beth E, McKenzie, Mark, Jeanfreau, Robert J, Kingsley, Jeffrey K, Henderson, Jeffrey A, Lane, Dakotah C, Ruíz-Palacios, Guillermo M, Corey, Lawrence, Neuzil, Kathleen M, Coombs, Robert W, Greninger, Alex L, Hutter, Julia, Ake, Julie A, Smith, Katherine, Woo, Wayne, Cho, Iksung, Glenn, Gregory M, Dubovsky, Filip, 2019nCoV-301 Study Group |
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| Rok vydání: | 2022 |
| Předmět: |
Adult
Male COVID-19 Vaccines Adolescent Clinical Trials and Supportive Activities Vaccine Efficacy Medical and Health Sciences Vaccine Related Clinical Research General & Internal Medicine Genetics Humans Single-Blind Method 2019nCoV-301 Study Group Mexico Lung Aged Vaccines SARS-CoV-2 Incidence Prevention COVID-19 Evaluation of treatments and therapeutic interventions General Medicine Middle Aged United States Infectious Diseases Emerging Infectious Diseases Good Health and Well Being COVID-19 Nucleic Acid Testing 6.1 Pharmaceuticals Original Article Immunization Infection |
| Zdroj: | The New England journal of medicine, vol 386, iss 6 The New England Journal of Medicine |
| ISSN: | 0461-1802 |
| Popis: | Background NVX-CoV2373 is an adjuvanted, recombinant spike protein nanoparticle vaccine that was shown to have clinical efficacy for the prevention of coronavirus disease 2019 (Covid-19) in phase 2b–3 trials in the United Kingdom and South Africa, but its efficacy had not yet been tested in North America. Methods We conducted a phase 3, randomized, observer-blinded, placebo-controlled trial in the United States and Mexico during the first half of 2021 to evaluate the efficacy and safety of NVX-CoV2373 in adults (≥18 years of age) who had not had severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection. Participants were randomly assigned in a 2:1 ratio to receive two doses of NVX-CoV2373 or placebo 21 days apart. The primary objective was to determine vaccine efficacy against reverse-transcriptase–polymerase-chain-reaction–confirmed Covid-19 occurring at least 7 days after the second dose. Vaccine efficacy against moderate-to-severe disease and against different variants was also assessed. Results Of the 29,949 participants who underwent randomization between December 27, 2020, and February 18, 2021, a total of 29,582 (median age, 47 years; 12.6% ≥65 years of age) received at least one dose: 19,714 received vaccine and 9868 placebo. Over a period of 3 months, 77 cases of Covid-19 were noted — 14 among vaccine recipients and 63 among placebo recipients (vaccine efficacy, 90.4%; 95% confidence interval [CI], 82.9 to 94.6; P |
| Databáze: | OpenAIRE |
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