SARS-CoV-2 Variant Vaccine Boosters Trial: Preliminary Analyses

作者：Angela R Branche, Nadine Rouphael, David Diemert, Ann R. Falsey, Cecilia Losada, Lindsey R. Baden, Sharon E. Frey, Jennifer A. Whitaker, Susan J. Little, Evan J. Anderson, Emmanuel B. Walter, Richard M. Novak, Richard Rupp, Lisa A. Jackson, Tara M. Babu, Angelica C Kottkamp, Anne F. Luetkemeyer, Lilly Cheng Immergluck, Rachel M. Presti, Martín Bäcker, Patricia Winokur, Siham Mahgoub, Paul Goepfert, Dahlene N. Fusco, Elissa Malkin, Jeffrey M. Bethony, Edward E. Walsh, Daniel S. Graciaa, Hady Samaha, Amy C Sherman, Stephen R. Walsh, Getahun Abate, Zacharoula Oikonomopoulou, Hana M. El Sahly, Thomas Martin, Christina A. Rostad, Michael J. Smith, Benjamin G Ladner, Laura Porterfield, Maya Dunstan, Anna Wald, Tamia Davis, Robert L. Atmar, Mark J. Mulligan, Kirsten E. Lyke, Christine M. Posavad, Megan A Meagher, David S. Stephens, Kathleen M. Neuzil, Kuleni Abebe, Heather Hill, Jim Albert, Teri C Lewis, Lisa Giebeig, Amanda Eaton, Antonia Netzl, Samuel Wilks, Sina Türeli, Mamodikoe Makhene, Sonja Crandon, Marina Lee, Seema Nayak, David C. Montefiori, Mat Makowski, Derek J. Smith, Paul C. Roberts, John H. Beigel, the COVAIL Study Group · 发表于：medRxiv · 年份：2022 · DOI：10.1101/2022.07.12.22277336 · 被引用次数：30 · 研究领域：SARS-CoV-2 and COVID-19 Research、vaccines and immunoinformatics approaches、SARS-CoV-2 detection and testing

ABSTRACT Background Protection from SARS-CoV-2 vaccines wanes over time and is compounded by emerging variants including Omicron subvariants. This study evaluated safety and immunogenicity of SARS-CoV-2 variant vaccines. Methods This phase 2 open-label, randomized trial enrolled healthy adults previously vaccinated with a SARS-CoV-2 primary series and a single boost. Eligible participants were randomized to one of six Moderna COVID19 mRNA vaccine arms (50µg dose): Prototype (mRNA-1273), Omicron BA.1+Beta (1 or 2 doses), Omicron BA.1+Delta, Omicron BA.1 monovalent, and Omicron BA.1+Prototype. Neutralization antibody titers (ID 50 ) were assessed for D614G, Delta, Beta and Omicron BA.1 variants and Omicron BA.2.12.1 and BA.4/BA.5 subvariants 15 days after vaccination. Results From March 30 to May 6, 2022, 597 participants were randomized and vaccinated. Median age was 53 years, and 20% had a prior SARS-CoV-2 infection. All vaccines were safe and well-tolerated. Day 15 geometric mean titers (GMT) against D614G were similar across arms and ages, and higher with prior infection. For uninfected participants, Day 15 Omicron BA.1 GMTs were similar across Omicron-containing vaccine arms (3724-4561) and higher than Prototype (1,997 [95%CI:1,482-2,692]). The Omicron BA.1 monovalent and Omicron BA.1+Prototype vaccines induced a geometric mean ratio (GMR) to Prototype for Omicron BA.1 of 2.03 (97.5%CI:1.37-3.00) and 1.56 (97.5%CI:1.06-2.31), respectively. A subset of samples from uninfect...