Final Analysis of Efficacy and Safety of Single-Dose Ad26.COV2.S

作者：JERALD C. SADOFF, Glenda Gray, An Vandebosch, Vicky Cárdenas, Georgi Shukarev, Beatriz Gilda Jegerhorn Grinsztejn, Paul Goepfert, Carla Truyers, Ilse Van Dromme, Bart Spiessens, Johan Vingerhoets, Jerome H. H. V. Custers, Gert C. Scheper, Merlin Lee Robb, John J. Treanor, Martin F. Ryser, Dan H. Barouch, Edith M. Swann, Mary Marovich, Kathleen Maletic Neuzil, Lawrence Corey, Jeffrey J. Stoddard, Karin Hardt, Javier Ruiz‐Guiñazú, Mathieu Le Gars, Hanneke Schuitemaker, Johan Van Hoof, Frank Struyf, Macaya Douoguih · 发表于：New England Journal of Medicine · 年份：2022 · DOI：10.1056/nejmoa2117608 · 被引用次数：254 · 研究领域：SARS-CoV-2 and COVID-19 Research、COVID-19 Clinical Research Studies、Immune responses and vaccinations

BACKGROUND: The Ad26.COV2.S vaccine was highly effective against severe-critical coronavirus disease 2019 (Covid-19), hospitalization, and death in the primary phase 3 efficacy analysis. METHODS: viral particles) or placebo. The primary end points were vaccine efficacy against moderate to severe-critical Covid-19 with onset at least 14 days after administration and at least 28 days after administration in the per-protocol population. Safety and key secondary and exploratory end points were also assessed. RESULTS: Median follow-up in this analysis was 4 months; 8940 participants had at least 6 months of follow-up. In the per-protocol population (39,185 participants), vaccine efficacy against moderate to severe-critical Covid-19 at least 14 days after administration was 56.3% (95% confidence interval [CI], 51.3 to 60.8; 484 cases in the vaccine group vs. 1067 in the placebo group); at least 28 days after administration, vaccine efficacy was 52.9% (95% CI, 47.1 to 58.1; 433 cases in the vaccine group vs. 883 in the placebo group). Efficacy in the United States, primarily against the reference strain (B.1.D614G) and the B.1.1.7 (alpha) variant, was 69.7% (95% CI, 60.7 to 76.9); efficacy was reduced elsewhere against the P.1 (gamma), C.37 (lambda), and B.1.621 (mu) variants. Efficacy was 74.6% (95% CI, 64.7 to 82.1) against severe-critical Covid-19 (with only 4 severe-critical cases caused by the B.1.617.2 [delta] variant), 75.6% (95% CI, 54.3 to 88.0) against Covid-19 leading to ...