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Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial

Title: Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial
Authors: Munro, Alasdair P.S.; Janani, Leila; Cornelius, Victoria; Aley, Parvinder K.; Babbage, Gavin; Baxter, David; Bula, Marcin; Cathie, Katrina; Chatterjee, Krishna; Dodd, Kate; Enever, Yvanne; Gokani, Karishma; Goodman, Anna L.; Green, Christopher A.; Harndahl, Linda; Haughney, John; Hicks, Alexander; van der Klaauw, Agatha A.; Kwok, Jonathan; Libri, Vincenzo; Llewelyn, Martin J.; McGregor, Alastair C.; Minassian, Angela M.; Moore, Patrick; Mughal, Mehmood; Mujadidi, Yama F; Murira, Jennifer; Osanlou, Orod; Osanlou, Rostam; Owens, Daniel R.; Pacurar, Mihaela; Palfreeman, Adrian; Pan, Daniel; Rampling, Tommy; Regan, Karen; Saich, Stephen; Salkeld, Jo; Saralaya, Dinesh; Sharma, Sunil; Sheridan, Ray; Sturdy, Ann; Thomson, Emma C.; Todd, Shirley; Twelves, Chris; Read, Robert C.; Charlton, Sue; Hallis, Bassam; Ramsay, Mary; Andrews, Nick; Nguyen-Van-Tam, Jonathan S.; Snape, Matthew D.; Liu, Xinxue; Faust, Saul N; Riordan, Andrew; Ustianowski, Andrew; Rogers, Chris A; Hughes, Stephen; Longshaw, Laura; Stockport, Jane; Hughes, Rachel; Grundy, Lynne; Tudor Jones, Lona; Guha, Arpan; Snashall, Emma; Eadsforth, Tom; Reeder, Sally; Storton, Kim; Munusamy, Malathi; Tandy, Bridget; Egbo, Akamino; Cox, Stephen; Ahmed, Nabeela Nazir; Shenoy, Anil; Bousfield, Rachel; Wixted, Donna; Gutteridge, Helen; Mansfield, Becky; Herbert, Christopher; Holliday, Kyra; Calderwood, James; Barker, Dominique; Brandon, Jacqueline; Tulloch, Hayley; Colquhoun, Suzie; Thorp, Helen; Radford, Helen; Evans, Julie; Baker, Helena; Thorpe, Jeanette; Batham, Sally; Hailstone, Jessica; Phillips, Rachael; Kumar, Dileep; Westwell, Fran; Makia, Fiona; Hopkins, NinaSimone; Barcella, Lara; Mpelembue, Mushiya; dabagh, Maja; lang, Matilda; khan, Farida; Adebambo, Olumide; Chita, Sunder; Corrah, Tumena; Whittington, Ashley; John, Laurence; Roche, Siobhan; Wagstaff, Lynda; Farrier, Adam; Bisnauthsing, Karen; Serafimova, Teona; Nanino, Elisa; Cooney, Enya; Wilson-Goldsmith, Jaimie; Nguyen, Hanna; Mazzella, Andrea; Jackson, Beth; Aslam, Suahil; Bawa, Tanveer; Broadhead, Samantha; Farooqi, Sadaf; Piper, Jo; Weighell, Rowena; Pickup, Lorinda; Shamtally, Djamila; Domingo, Jason; Kourampa, Evgenia; Hale, Colin; Gibney, Jennifer; Stackpoole, Michael; Rashid-Gardner, Zalina; Lyon, Rebecca; McDonnell, Chloe; Cole, Christine; Stewart, Anna; McMillan, Gillian; Savage, Mary; Beckett, Helen; Moorbey, Chantelle; Desai, Amisha; Brown, Claire; Naker, Kush; Qureshi, Ehsaan; Trinham, Charlotte; Sabine, Charlotte; Moore, Sophie; Hurdover, Steve; Justice, Edwin; Smith, David; Plested, Emma; Ferreira Da Silva, Carla; White, Rachel; Robinson, Hannah; Cifuentes, Liliana; Morshead, Gertraud; Drake-Brockman, Rachael; Kinch, Patrick; Kasanyinga, Mwila; Clutterbuck, Elizabeth A.; Bibi, Sagida; Stuart, Arabella S.V.; Shaw, Robert H.; Singh, Michael; Champaneri, Trishna; Irwin, Margaret; Khan, Mohammed; Kownacka, Alicja; Nabunjo, Martha; Osuji, Carool; Hladkiwskyj, John; Galvin, Dominic; Patel, Gita; Mouland, Johanna; Longhurst, Beverley; Moon, Maria; Giddins, Beth; Pereira Dias Alves, Carlota; Richmond, Leah; Minnis, Christine; Baryschpolec, Sonia; Elliott, Scott; Fox, Lauren; Graham, Victoria; Baker, Natalie; Godwin, Kerry; Buttigieg, Karren; Knight, Chanice; Brown, Phillip; Lall, Paminder; Shaik, Imam; Chiplin, Emily; Brunt, Emily; Leung, Stephanie; Allen, Lauren; Thomas, Steve; Fraser, Sara; Choi, Bea; Gouriet, Jade; Freedman, Andrew; Perkins, Jonathan; Gowland, Andrew; Macdonald, Jonathan; Seenan, John Paul; Starinskij, Igor; Seaton, Andrew; Peters, Erica; Singh, Stephen; Gardside, Ben; Bonnaud, Avril; Davies, Ceri; Gordon, Elizabeth; Keenan, Samantha; Hall, Jane; Wilkins, Suzanne; Tasker, Suzanne; James, Rob; Seath, Ingrid; Littlewood, Kelly; Newman, Joseph; Boubriak, Iryna; Suggitt, Debbie; Haydock, Helen; Bennett, Sara; Woodyatt, Wiesia; Hughes, Kerry; Bell, Judith; Coughlan, Tricia; van Welsenes, Donald; Kamal, Mohammed; Cooper, Chris; Tunstall, Simon; Ronan, Nicholas; Cutts, Rebecca; Dare, Tracey; Yim, Yee Ting Nicole; Whittley, Sarah; Ricamara, Marivic; Hamal, Shama; Adams, Kirsty; Baker, Holly; Driver, Kimberley; Turner, Nicola; Rawlins, Todd; Roy, Subarna; Merida-Morillas, Marta; Sakagami, Yukari; Andrews, Antonette; Goncalves cordeiro, Lillian; Stokes, Matthew; Ambihapathy, Wythehi; Spencer, Joanne; Parungao, Nina; Berry, Lisa; Cullinane, James; Presland, Laura; Ross-Russell, Amy; Warren, Sarah; Baker, Jonathan; Oliver, Abigail; Buadi, Amanda; Lee, Kim; Haskell, Louise; Romani, Rossana; Bentley, Ian; Whitbred, Tim; Fowler, Simon; Gavin, John; Magee, Alan; Watson, Tara; Nightingale, Kari; Marius, Phedra; Summerton, Eloise; Locke, Emily; Honey, Thomas; Lingwood, Aidan; de la Haye, Anastasia; Elliott, Ryan Stephen; Underwood, Karen; King, Mikayala; Davies-Dear, Sharon; Horsfall, Emily; Chalwin, Olivia; Burton, Holly; Edwards, Christopher J.; Welham, Benjamin; Garrahy, Sarah; Hall, Fran; Ladikou, Eleni; Mullan, Dee; Hansen, Daniel; Campbell, Marion; Dos Santos, Filipa; Habash-Bailey, Haniah; Lakeman, Nicki; Branney, Debbie; Vamplew, Luke; Hogan, Alison; Frankham, Jorden; Wiselka, Martin; Vail, Dennyl; Wenn, Victoria; Renals, Valerie; Ellis, Kate; Lewis-Taylor, Jessica; Magan, Javier; Hardy, Anna; Appleby, Kim
Publisher Information: The Lancet Publishing Group
Publication Year: 2021
Collection: University of Glasgow: Enlighten - Publications
Description: Background: Few data exist on the comparative safety and immunogenicity of different COVID-19 vaccines given as a third (booster) dose. To generate data to optimise selection of booster vaccines, we investigated the reactogenicity and immunogenicity of seven different COVID-19 vaccines as a third dose after two doses of ChAdOx1 nCov-19 (Oxford–AstraZeneca; hereafter referred to as ChAd) or BNT162b2 (Pfizer–BioNtech, hearafter referred to as BNT). Methods: COV-BOOST is a multicentre, randomised, controlled, phase 2 trial of third dose booster vaccination against COVID-19. Participants were aged older than 30 years, and were at least 70 days post two doses of ChAd or at least 84 days post two doses of BNT primary COVID-19 immunisation course, with no history of laboratory-confirmed SARS-CoV-2 infection. 18 sites were split into three groups (A, B, and C). Within each site group (A, B, or C), participants were randomly assigned to an experimental vaccine or control. Group A received NVX-CoV2373 (Novavax; hereafter referred to as NVX), a half dose of NVX, ChAd, or quadrivalent meningococcal conjugate vaccine (MenACWY) control (1:1:1:1). Group B received BNT, VLA2001 (Valneva; hereafter referred to as VLA), a half dose of VLA, Ad26.COV2.S (Janssen; hereafter referred to as Ad26) or MenACWY (1:1:1:1:1). Group C received mRNA1273 (Moderna; hereafter referred to as m1273), CVnCov (CureVac; hereafter referred to as CVn), a half dose of BNT, or MenACWY (1:1:1:1). Participants and all investigatory staff were blinded to treatment allocation. Coprimary outcomes were safety and reactogenicity and immunogenicity of anti-spike IgG measured by ELISA. The primary analysis for immunogenicity was on a modified intention-to-treat basis; safety and reactogenicity were assessed in the intention-to-treat population. Secondary outcomes included assessment of viral neutralisation and cellular responses. This trial is registered with ISRCTN, number 73765130. Findings: Between June 1 and June 30, 2021, 3498 people were screened. 2878 ...
Document Type: article in journal/newspaper
File Description: text
Language: English
Relation: https://eprints.gla.ac.uk/259998/1/259998.pdf; Munro, A. P.S. et al. (2021) Safety and immunogenicity of seven COVID-19 vaccines as a third dose (booster) following two doses of ChAdOx1 nCov-19 or BNT162b2 in the UK (COV-BOOST): a blinded, multicentre, randomised, controlled, phase 2 trial. Lancet , 398(10318), pp. 2258-2276. (doi:10.1016/S0140-6736(21)02717-3 ) (PMID:34863358) (PMCID:PMC8639161)
Availability: https://eprints.gla.ac.uk/259998/; https://eprints.gla.ac.uk/259998/1/259998.pdf
Rights: cc_by_4
Accession Number: edsbas.E7D4F2DF
Database: BASE