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Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomised controlled trials (COV001 and COV002)

Title: Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomised controlled trials (COV001 and COV002)
Authors: Flaxman, Amy; Marchevsky, Natalie G; Jenkin, Daniel; Aboagye, Jeremy; Aley, Parvinder K; Angus, Brian; Belij-Rammerstorfer, Sandra; Bibi, Sagida; Bittaye, Mustapha; Cappuccini, Federica; Cicconi, Paola; Clutterbuck, Elizabeth A; Davies, Sophie; Dejnirattisai, Wanwisa; Dold, Christina; Ewer, Katie J; Folegatti, Pedro M; Fowler, Jamie; Hill, Adrian V S; Kerridge, Simon; Minassian, Angela M; Mongkolsapaya, Juthathip; Mujadidi, Yama F; Plested, Emma; Ramasamy, Maheshi N; Robinson, Hannah; Sanders, Helen; Sheehan, Emma; Smith, Holly; Snape, Matthew D; Song, Rinn; Woods, Danielle; Screaton, Gavin; Gilbert, Sarah C; Voysey, Merryn; Pollard, Andrew J; Lambe, Teresa; Adlou, Syed; Aley, Robert; Ali, Aabidah; Anslow, Rachel; Baker, Megan; Baker, Phillip; Barrett, Jordan R.; Bates, Louise; Beadon, Kirsten; Beckley, Rebecca; Bell, Jonathan; Bellamy, Duncan; Beveridge, Amy; Bissett, Cameron; Blackwell, Luke; Bletchly, Heather; Boyd, Amy; Bridges-Webb, Alice; Brown, Charlie; Byard, Nicholas; Camara, Susana; Cifuentes Gutierrez, Liliana; Collins, Andrea M.; Cooper, Rachel; Crocker, Wendy E.M.; Darton, Thomas C.; Davies, Hannah; Davies, Judith; Demissie, Tesfaye; Di Maso, Claudio; Dinesh, Tanya; Donnellan, Francesca R.; Douglas, Alexander D.; Drake-Brockman, Rachael; Duncan, Christopher J.A.; Elias, Sean C.; Emary, Katherine R.W.; Ghulam Farooq, Mutjaba; Faust, Saul N.; Felle, Sally; Ferreira, Daniela; Ferreira Da Silva, Carla; Finn, Adam; Ford, Karen J.; Francis, Emma; Furze, Julie; Fuskova, Michelle; Galiza, Eva; Gibertoni Cruz, Ana; Godfrey, Leila; Goodman, Anna L.; Green, Catherine; Green, Christopher A.; Greenwood, Nicola; Harrison, Daisy; Hart, Thomas C.; Hawkins, Sophia; Heath, Paul T.; Hill, Helen; Hillson, Kushalinii; Horsington, Bryn; Hou, Mimi M.; Howe, Elizabeth; Howell, Nicola; Joe, Carina; Jones, Elizabeth; Kasanyinga, Mwila; Keen, Jade; Kelly, Sarah; Kerr, David; Khan, Liaquat; Khozoee, Baktash; Kinch, Jasmin; Kinch, Patrick; Koleva, Stanislava; Kwok, Jonathan; Larkworthy, Colin W.; Lawrie, Alison M.; Lazarus, Rajeka; Lees, Emily A.; Li, Grace; Libri, Vincenzo; Lillie, Patrick J.; Linder, Aline; Long, Fei; Lopez Ramon, Raquel; Mabbett, Reece; Makinson, Rebecca; Marinou, Spyridoula; Marlow, Emma; Marshall, Julia L.; Mazur, Olga; McEwan, Joanne; McGregor, Alastair C.; Mokaya, Jolynne; Morey, Ella; Morshead, Gertraud; Morter, Richard; Muller, Jilly; Mweu, Philomena; Noristani, Rabiullah; Owino, Nelly; Polo Peralta Alvarez, Marco; Platt, Abigail; Pollock, Katrina M.; Poulton, Ian; Provstgaard-Morys, Samuel; Pulido-Gomez, David; Rajan, Matthew; Ramos Lopez, Fernando; Ritchie, Adam; Roberts, Hannah; Rollier, Christine; Rudiansyah, Indra; Sanders, Katherine; Saunders, Jack E.; Seddiqi, Samiullah; Sharpe, Hannah R.; Shaw, Robert; Silva-Reyes, Laura; Singh, Nisha; Smith, David J.; Smith, Catherine C.; Smith, Andrew; Spencer, Alexandra J.; Stuart, Arabella S.V.; Sutherland, Rebecca; Szigeti, Anna; Tang, Karly; Thomas, Merin; Thomas, Tonia M.; Thompson, Amber; Thomson, Emma C.; Török, Estée M.; Toshner, Mark; Tran, Nguyen; Trivett, Rose; Turnbull, Iain; Turner, Cheryl; Turner, David P.J.; Ulaszewska, Marta; Vichos, Iason; Walker, Laura; Watson, Marion E.; Whelan, Conor; White, Rachel; Williams, Sarah J.; Williams, Christopher J.A.; Wright, Daniel; Yao, Andy
Publisher Information: The Lancet Publishing Group
Publication Year: 2021
Collection: University of Glasgow: Enlighten - Publications
Description: Background: COVID-19 vaccine supply shortages are causing concerns about compromised immunity in some countries as the interval between the first and second dose becomes longer. Conversely, countries with no supply constraints are considering administering a third dose. We assessed the persistence of immunogenicity after a single dose of ChAdOx1 nCoV-19 (AZD1222), immunity after an extended interval (44–45 weeks) between the first and second dose, and response to a third dose as a booster given 28–38 weeks after the second dose. Methods: In this substudy, volunteers aged 18–55 years who were enrolled in the phase 1/2 (COV001) controlled trial in the UK and had received either a single dose or two doses of 5 × 1010 viral particles were invited back for vaccination. Here we report the reactogenicity and immunogenicity of a delayed second dose (44–45 weeks after first dose) or a third dose of the vaccine (28–38 weeks after second dose). Data from volunteers aged 18–55 years who were enrolled in either the phase 1/2 (COV001) or phase 2/3 (COV002), single-blinded, randomised controlled trials of ChAdOx1 nCoV-19 and who had previously received a single dose or two doses of 5 × 1010 viral particles are used for comparison purposes. COV001 is registered with ClinicalTrials.gov, NCT04324606, and ISRCTN, 15281137, and COV002 is registered with ClinicalTrials.gov, NCT04400838, and ISRCTN, 15281137, and both are continuing but not recruiting. Findings: Between March 11 and 21, 2021, 90 participants were enrolled in the third-dose boost substudy, of whom 80 (89%) were assessable for reactogenicity, 75 (83%) were assessable for evaluation of antibodies, and 15 (17%) were assessable for T-cells responses. The two-dose cohort comprised 321 participants who had reactogenicity data (with prime-boost interval of 8–12 weeks: 267 [83%] of 321; 15–25 weeks: 24 [7%]; or 44–45 weeks: 30 [9%]) and 261 who had immunogenicity data (interval of 8–12 weeks: 115 [44%] of 261; 15–25 weeks: 116 [44%]; and 44–45 weeks: 30 [11%]). 480 ...
Document Type: article in journal/newspaper
File Description: text
Language: English
Relation: https://eprints.gla.ac.uk/260578/1/260578.pdf; Flaxman, A. et al. (2021) Reactogenicity and immunogenicity after a late second dose or a third dose of ChAdOx1 nCoV-19 in the UK: a substudy of two randomised controlled trials (COV001 and COV002). Lancet , 398(10304), pp. 981-990. (doi:10.1016/S0140-6736(21)01699-8 ) (PMID:34480858) (PMCID:PMC8409975)
Availability: https://eprints.gla.ac.uk/260578/; https://eprints.gla.ac.uk/260578/1/260578.pdf
Rights: cc_by_4
Accession Number: edsbas.4AE5136F
Database: BASE