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Immunogenicity and safety of a bivalent (omicron BA.5 plus ancestral) SARS-CoV-2 recombinant spike protein vaccine as a heterologous booster dose: interim analysis of a phase 3, non-inferiority, randomised, clinical trial

2024; Elsevier BV; Volume: 24; Issue: 6 Linguagem: Inglês

10.1016/s1473-3099(24)00077-x

1474-4457

Chijioke Bennett, Wayne Woo, Mark Bloch, King Cheung, Paul Griffin, Rahul Mohan, Sachin Kumar Deshmukh, Mark Arya, Oscar Cumming, A. Munro Neville, Toni G. McCallum Pardey, Joyce S. Plested, Shane Cloney-Clark, Mingzhu Zhu, Raj Kalkeri, Nita Patel, Alex Marcheschi, Jennifer L. Swan, Gale Smith, Iksung Cho, Gregory M. Glenn, Robert Walker, Raburn M. Mallory, Anna Anderson, Mary Jasmin Ang, Timothy Barnes, Michelle Bassin, Kate Bessey, Simon Bowler, S. A. Bull, Lucy Burr, Robert Burton, Michelle L. Byrne, Robert J. Carroll, Nicholas Chee, Aaron Choy, Malcolm Clark, Marije Dalebout, Peter De Wet, Kshama Deshmukh, Sergio Diez Alvarez, Dominic Douglas, Jacqueline Engelander, Carla Evangelista, Stuart Game, Noor Glass, Elizabeth Gunner, Jennifer Han, Michael Harrison, J Kiang, Thazin Hlaing, Divyansh Joshi, Sheree Joyce, Karen Kaluhin, Milanka Kavic, Juliana Kononov, Gary Lee, Wei‐I Lee, Indika Leelasena, Esmond Leong, Ivan Lim, Graham Lister, Denissa Loh, Mary Magdy, Callum Maggs, Amith Mammoottil, Shannon McCarthy, Nicole McKay, M. Melek, Adrian Michael Barnett, Rahul Mohan, Andrew Moore, Amanda L. Moore, Louise Murdoch, Fiona Napier-Flood, Ushma Narsai, Alexander Neville, Paul Nguyen, Ekaterina Odarchenko, Toni McCallum Pardey, Dick Quan, Ushank Ranagsinghe, Roy Rasalam, Shiva Rayar, Gonasagaran Jay Ruthnam, Pi Seet, Deon Smith, Krishna Srilakshmanan, Angela Taggart, Florence Tiong, Boon Toh, Eniko Ujvary, Stephanie E Wallace, Rebecca B. Wolf, Ian Chi Kei Wong, Hye Jin Yoo, Rhys Young,

SARS-CoV-2 detection and testing

SARS-CoV-2 variants evade immunity despite vaccination with prototype COVID-19 vaccines or previous infection. The 2019nCoV-311 (part 2) study is evaluating immune responses after two booster doses of a vaccine containing the omicron BA.5 subvariant spike protein in adults previously vaccinated with a prototype mRNA vaccine. This interim analysis reports on day 28 immunogenicity and safety outcomes after one booster dose.