Safety and Efficacy of Single-Dose Ad26.COV2.S Vaccine against Covid-19
| Autor: | Jerald, Sadoff, Glenda, Gray, An, Vandebosch, Vicky, Cárdenas, Georgi, Shukarev, Beatriz, Grinsztejn, Paul A, Goepfert, Carla, Truyers, Hein, Fennema, Bart, Spiessens, Kim, Offergeld, Gert, Scheper, Kimberly L, Taylor, Merlin L, Robb, John, Treanor, Dan H, Barouch, Jeffrey, Stoddard, Martin F, Ryser, Mary A, Marovich, Kathleen M, Neuzil, Lawrence, Corey, Nancy, Cauwenberghs, Tamzin, Tanner, Karin, Hardt, Javier, Ruiz-Guiñazú, Mathieu, Le Gars, Hanneke, Schuitemaker, Johan, Van Hoof, Frank, Struyf, Macaya, Douoguih, Marcus, Zervos |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
Male 2019-20 coronavirus outbreak COVID-19 Vaccines Adolescent Coronavirus disease 2019 (COVID-19) viruses Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) 030204 cardiovascular system & hematology law.invention Young Adult 03 medical and health sciences Immunogenicity Vaccine 0302 clinical medicine Double-Blind Method law Humans Medicine 030212 general & internal medicine Vector (molecular biology) Aged Proportional Hazards Models Ad26COVS1 business.industry Incidence Immunogenicity Patient Acuity COVID-19 virus diseases General Medicine Middle Aged Virology Hospitalization Clinical trial Multicenter study Asymptomatic Diseases Recombinant DNA Female business |
| Zdroj: | New England Journal of Medicine. 384:2187-2201 |
| ISSN: | 1533-4406 0028-4793 |
| DOI: | 10.1056/nejmoa2101544 |
| Popis: | The Ad26.COV2.S vaccine is a recombinant, replication-incompetent human adenovirus type 26 vector encoding full-length severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) spike protein in a prefusion-stabilized conformation.In an international, randomized, double-blind, placebo-controlled, phase 3 trial, we randomly assigned adult participants in a 1:1 ratio to receive a single dose of Ad26.COV2.S (5×10The per-protocol population included 19,630 SARS-CoV-2-negative participants who received Ad26.COV2.S and 19,691 who received placebo. Ad26.COV2.S protected against moderate to severe-critical Covid-19 with onset at least 14 days after administration (116 cases in the vaccine group vs. 348 in the placebo group; efficacy, 66.9%; adjusted 95% confidence interval [CI], 59.0 to 73.4) and at least 28 days after administration (66 vs. 193 cases; efficacy, 66.1%; adjusted 95% CI, 55.0 to 74.8). Vaccine efficacy was higher against severe-critical Covid-19 (76.7% [adjusted 95% CI, 54.6 to 89.1] for onset at ≥14 days and 85.4% [adjusted 95% CI, 54.2 to 96.9] for onset at ≥28 days). Despite 86 of 91 cases (94.5%) in South Africa with sequenced virus having the 20H/501Y.V2 variant, vaccine efficacy was 52.0% and 64.0% against moderate to severe-critical Covid-19 with onset at least 14 days and at least 28 days after administration, respectively, and efficacy against severe-critical Covid-19 was 73.1% and 81.7%, respectively. Reactogenicity was higher with Ad26.COV2.S than with placebo but was generally mild to moderate and transient. The incidence of serious adverse events was balanced between the two groups. Three deaths occurred in the vaccine group (none were Covid-19-related), and 16 in the placebo group (5 were Covid-19-related).A single dose of Ad26.COV2.S protected against symptomatic Covid-19 and asymptomatic SARS-CoV-2 infection and was effective against severe-critical disease, including hospitalization and death. Safety appeared to be similar to that in other phase 3 trials of Covid-19 vaccines. (Funded by Janssen Research and Development and others; ENSEMBLE ClinicalTrials.gov number, NCT04505722.). |
| Databáze: | OpenAIRE |
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