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Efficacy of a bivalent (D614 + B.1.351) SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant in adults: a phase 3, parallel, randomised, modified double-blind, placebo-controlled trial

Authors :
Dayan, Gustavo H
Rouphael, Nadine
Walsh, Stephen R
Chen, Aiying
Grunenberg, Nicole
Allen, Mary
Antony, Johannes
Asante, Kwaku Poku
Bhate, Amit Suresh
Beresnev, Tatiana
Bonaparte, Matthew I
Celle, Médéric
Ceregido, Maria Angeles
Corey, Lawrence
Dobrianskyi, Dmytro
Fu, Bo
Grillet, Marie-Helene
Keshtkar-Jahromi, Maryam
Juraska, Michal
Kee, Jia Jin
Kibuuka, Hannah
Koutsoukos, Marguerite
Masotti, Roger
Michael, Nelson L
Neuzil, Kathleen M
Reynales, Humberto
Robb, Merlin L
Villagómez Martínez, Sandra M
Sawe, Fredrick
Schuerman, Lode
Tong, Tina
Treanor, John
Wartel, T Anh
Diazgranados, Carlos A
Chicz, Roman M
Gurunathan, Sanjay
Savarino, Stephen
Sridhar, Saranya
Abalos, Karina
Accini, Jose
Aloysia, Naveena
Amuasi, John Humphrey
Ansah, Nana Akosua
Benkeser, David
Berge, Aude
Beyko, Hanna
Bilotkach, Oleksandra
Breuer, Thomas
Bonfanti, Alberto Cadena
Bukusi, Elisabeth
Canter, Richard
Carrillo, Jaime Augusto
Chansinghakul, Danaya
Coux, Florence
Das, Chandan
Das, Santa Kumar
Devlin, Louis
Espinoza, Luis
Fay, Michael
Follmann, Dean
Frago, Carina
Garinga, Agnes
Gilbert, Peter B
Gonzalez, Claudia
Granados, Maria Angelica
Guillery, Lea
Huang, Ying
Hudzina, Kathy
Jain, Manish
Kanodia, Piush
Khandelwal, Nitin
Mutuluuza, Cissy Kityo
Kiweewa, Francis
Kiwanuka, Noah
Kosolsak, Chalit
Kukian, Darshna
Kushwaha, Jitendra Singh
Laot, Thelma
Lopez-Medina, Eduardo
Macareno Arroyo, Hugo
Mandaliya, Kishorchandra
Mamod, Stephanie
Mangarule, Somnath
Martínez, Javier
McClelland, Scott
Menard, Lisa
Mendoza, Sandra
Mohapatra, Satyajit
Moreau, Catherine
Mugo, Nelly
Nduba, Videlis
Noriega, Fernando
Ntege, Patricia Nahirya
Okech, Brenda
Otero, Maria
Ouma, Samuel Gurrion
Oyieko, Janet
Paredes, Mercedes
Pardo, Erwin
Postol, Svitlana
Pekala, David
Peng, Penny
Py, Marie-Laure
Rivas, Enrique
Rivero, Rafael
Rodriguez, Edith
Saleh, Mansoor
Sánchez, Pedro
Sater, Nessryne
Shah, Jinen
Shrestha, Rajeev
Siika, Abraham
Singh, Chandramani
Singh, Veer Bahadur
Tamrakar, Dipesh
Tavares Da-Silva, Fernanda
Otieno Tina, Lucas
Velasquez, Hector
Wabwire, Deo
Wajja, Anne
Zaworski, Elodie
Zhang, Nianxian
Source :
The Lancet Respiratory Medicine; 20230101, Issue: Preprints
Publication Year :
2023

Abstract

COVID-19 vaccines with alternative strain compositions are needed to provide broad protection against newly emergent SARS-CoV-2 variants of concern. This study aimed to describe the clinical efficacy and safety of a bivalent SARS-CoV-2 recombinant protein vaccine as a two-injection primary series during a period of circulation of the omicron (B.1.1.529) variant.

Details

Language :
English
ISSN :
22132600 and 22132619
Issue :
Preprints
Database :
Supplemental Index
Journal :
The Lancet Respiratory Medicine
Publication Type :
Periodical
Accession number :
ejs63976215
Full Text :
https://doi.org/10.1016/S2213-2600(23)00263-1