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Comparison of bivalent and monovalent SARS-CoV-2 variant vaccines: the phase 2 randomized open-label COVAIL trial

2023; Nature Portfolio; Volume: 29; Issue: 9 Linguagem: Inglês

10.1038/s41591-023-02503-4

1546-170X

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 C. Martin, Satoshi Kamidani, 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, Kalyani Telu, Jinjian Mu, Teri C Lewis, Lisa Giebeig, Amanda Eaton, Antonia Netzl, Samuel Wilks, Sina Türeli, Mamodikoe Makhene, Sonja Crandon, David C. Montefiori, Mat Makowski, Derek J. Smith, Seema Nayak, Paul C. Roberts, John H. Beigel, Edward E. Walsh, Patrick Kingsley, Kari Steinmetz, Michael Peasley, Cassie Grimsley Ackerley, Kristen Unterberger, Aimee Desrosiers, Marc Siegel, Alexandra Tong, Rebecca Rooks, Daniel F. Hoft, Irene Graham, Wendy A. Keitel, Catherine Healy, Nicole Carter, Steven Hendrickx, Christina A. Rostad, Etza Peters, L. Nolan, M. Anthony Moody, Kenneth E. Schmader, Andrea Wendrow, Jessica Herrick, Rebecca Lau, Barbara Carste, Taylor Krause, Kirsten Hauge, Celia Engelson, Vijaya L Soma, Chloe Harris, Azquena Munoz Lopez, Erica Johnson, Austin Chan, Fatima Ali, Trisha Chan Parker, Jane A. O’Halloran, Ryley M. Thompson, Kimberly R. Byrnes, Asif Noor, Jeffery L. Meier, Jack T. Stapleton, Cynthia Maxwell, Sarah Shami, Arnaud Drouin, Florice K Numbi, M. Juliana McElrath, Mike Gale, Holly Baughman, Lisa McQuarrie, Theresa Engel, Caleb Griffith, W L McDonald, Alissa E Burkey, Lisa Hoopengardner, Jessica E. Linton, Nikki Gettinger, Marina Lee, Mohammed Elsafy, Rhonda Pikaart-Tautges, Janice Arega, Binh Hoang, Dan Curtin, Hyung Il Koo, Elisa Sindall, Marciela M. DeGrace, Diane J. Post, David S. Stephens, Kathleen M. Neuzil, Monica M. Farley, Jeanne Marrazzo, Sidnee Paschal Young, Jeffery Lennox, Robert L. Atmar, Linda M. McNeil, Elizabeth R. Brown,

Vaccine Coverage and Hesitancy

Vaccine protection against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection wanes over time, requiring updated boosters. In a phase 2, open-label, randomized clinical trial with sequentially enrolled stages at 22 US sites, we assessed safety and immunogenicity of a second boost with monovalent or bivalent variant vaccines from mRNA and protein-based platforms targeting wild-type, Beta, Delta and Omicron BA.1 spike antigens. The primary outcome was pseudovirus neutralization titers at 50% inhibitory dilution (ID