Interim Results of a Phase 1–2a Trial of Ad26.COV2.S Covid-19 Vaccine

作者：Jerald Sadoff, Mathieu Le Gars, Georgi Shukarev, Dirk Heerwegh, Carla Truyers, Anne Marit de Groot, Jeroen N. Stoop, Sarah M. Tete, Wim Van Damme, Isabel Leroux‐Roels, Pieter-Jan Berghmans, Murray Kimmel, Pierre Van Damme, Jan de Hoon, William Smith, Kathryn E. Stephenson, Stephen C. De Rosa, Kristen W. Cohen, M. Juliana McElrath, Emmanuel Cormier, Gert C. Scheper, Dan H. Barouch, Jenny Hendriks, Frank Struyf, Macaya Douoguih, Johan Van Hoof, Hanneke Schuitemaker · 发表于：New England Journal of Medicine · 年份：2021 · DOI：10.1056/nejmoa2034201 · 被引用次数：1187 · 研究领域：Virus-based gene therapy research、SARS-CoV-2 and COVID-19 Research、COVID-19 Clinical Research Studies

BACKGROUND: Efficacious vaccines are urgently needed to contain the ongoing coronavirus disease 2019 (Covid-19) pandemic of infection with severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). A candidate vaccine, Ad26.COV2.S, is a recombinant, replication-incompetent adenovirus serotype 26 (Ad26) vector encoding a full-length and stabilized SARS-CoV-2 spike protein. METHODS: viral particles (high dose) per milliliter or placebo in a single-dose or two-dose schedule. Longer-term data comparing a single-dose regimen with a two-dose regimen are being collected in cohort 2; those results are not reported here. The primary end points were the safety and reactogenicity of each dose schedule. RESULTS: After the administration of the first vaccine dose in 805 participants in cohorts 1 and 3 and after the second dose in cohort 1, the most frequent solicited adverse events were fatigue, headache, myalgia, and injection-site pain. The most frequent systemic adverse event was fever. Systemic adverse events were less common in cohort 3 than in cohort 1 and in those who received the low vaccine dose than in those who received the high dose. Reactogenicity was lower after the second dose. Neutralizing-antibody titers against wild-type virus were detected in 90% or more of all participants on day 29 after the first vaccine dose (geometric mean titer [GMT], 212 to 354), regardless of vaccine dose or age group, and reached 96% by day 57 with a further increase in titers (GMT, 288 to 4...