Immunogenicity of the Ad26.COV2.S Vaccine for COVID-19

作者：Kathryn E. Stephenson, Mathieu Le Gars, Jerald Sadoff, Anne Marit de Groot, Dirk Heerwegh, Carla Truyers, Caroline Atyeo, Carolin Loos, Abishek Chandrashekar, Katherine McMahan, Lisa H. Tostanoski, Jingyou Yu, Makda S. Gebre, Catherine Jacob-Dolan, Zhenfeng Li, Shivani Patel, Lauren Peter, Jinyan Liu, Erica N. Borducchi, Joseph P. Nkolola, Morgana Souza, Chen Sabrina Tan, Rebecca Zash, Boris Jülg, Ruvandhi R. Nathavitharana, Roger Shapiro, Ahmed Abdul Azim, Carolyn D. Alonso, Kate Jaegle, Jessica L. Ansel, Diane G. Kanjilal, Caitlin J. Guiney, Connor Bradshaw, Anna L. Tyler, Tatenda Makoni, Katherine E. Yanosick, Michael S. Seaman, Douglas A. Lauffenburger, Galit Alter, Frank Struyf, Macaya Douoguih, Johan Van Hoof, Hanneke Schuitemaker, Dan H. Barouch · 发表于：JAMA · 年份：2021 · DOI：10.1001/jama.2021.3645 · 被引用次数：336 · 研究领域：SARS-CoV-2 and COVID-19 Research、vaccines and immunoinformatics approaches、COVID-19 Clinical Research Studies

Importance: Control of the global COVID-19 pandemic will require the development and deployment of safe and effective vaccines. Objective: To evaluate the immunogenicity of the Ad26.COV2.S vaccine (Janssen/Johnson & Johnson) in humans, including the kinetics, magnitude, and phenotype of SARS-CoV-2 spike-specific humoral and cellular immune responses. Design, Setting, and Participants: Twenty-five participants were enrolled from July 29, 2020, to August 7, 2020, and the follow-up for this day 71 interim analysis was completed on October 3, 2020; follow-up to assess durability will continue for 2 years. This study was conducted at a single clinical site in Boston, Massachusetts, as part of a randomized, double-blind, placebo-controlled phase 1 clinical trial of Ad26.COV2.S. Interventions: Participants were randomized to receive 1 or 2 intramuscular injections with 5 × 1010 viral particles or 1 × 1011 viral particles of Ad26.COV2.S vaccine or placebo administered on day 1 and day 57 (5 participants in each group). Main Outcomes and Measures: Humoral immune responses included binding and neutralizing antibody responses at multiple time points following immunization. Cellular immune responses included immunospot-based and intracellular cytokine staining assays to measure T-cell responses. Results: Twenty-five participants were randomized (median age, 42; age range, 22-52; 52% women, 44% male, 4% undifferentiated), and all completed the trial through the day 71 interim end point. B...