TY - JOUR
AU - Voysey, Merryn
AU - Clemens, Sue Ann Costa
AU - Madhi, Shabir A.
AU - Weckx, Lily Y.
AU - Folegatti, Pedro M.
AU - Aley, Parvinder K.
AU - Angus, Brian
AU - Baillie, Vicky L.
AU - Barnabas, Shaun L.
AU - Bhorat, Qasim E.
AU - Bibi, Sagida
AU - Briner, Carmen
AU - Cicconi, Paola
AU - Collins, Andrea M.
AU - Colin-Jones, Rachel
AU - Cutland, Clare L.
AU - Darton, Thomas C.
AU - Dheda, Keertan
AU - Duncan, Christopher J.A.
AU - Emary, Katherine R.W.
AU - Ewer, Katie J.
AU - Fairlie, Lee
AU - Faust, Saul N.
AU - Feng, Shuo
AU - Ferreira, Daniela M.
AU - Finn, Adam
AU - Goodman, Anna L.
AU - Green, Catherine M.
AU - Green, Christopher A.
AU - Heath, Paul T.
AU - Hill, Catherine
AU - Hill, Helen C.
AU - Hirsch, Ian
AU - Hodgson, Susanne H. C.
AU - Izu, Alane
AU - Jackson, Susan
AU - Jenkin, Daniel
AU - Joe, Carina
AU - Kerridge, Simon
AU - Koen, Anthonet
AU - Kwatra, Gaurav
AU - Lazarus, Rajeka
AU - Lawrie, Alison M.
AU - Lelliott, Alice
AU - Libri, Vincenzo
AU - Lillie, Patrick J.
AU - Mallory, Raburn
AU - Mendes, Ana V.A.
AU - Milan, Eveline P.
AU - Minassian, Angela M.
AU - McGregor, Alastair C.
AU - Morrison, Hazel
AU - Mujadidi, Yama F.
AU - Nana, Anusha
AU - O'Reilly, Peter J.
AU - Padayachee, Sherman D.
AU - Pittella, Ana
AU - Plested, Emma
AU - Pollock, Katrina M.
AU - Ramasamy, Maheshi N.
AU - Rhead, Sarah
AU - Schwarzbold, Alexandre V.
AU - Singh, Nisha
AU - Smith, Andrew
AU - Song, Rinn
AU - Snape, Matthew D.
AU - Sprinz, Eduardo
AU - Sutherland, Rebecca K.
AU - Tarrant, Richard
AU - Thomson, Emma C.
AU - Török, Mark and Turner
AU - Sorio, Guilherme L.
AU - Sorley, Kim
AU - Sosa-Rodriguez, Tiffany
AU - Souza, Cinthia M.C.D.L.
AU - Souza, Bruno S.D.F.
AU - Souza, Alessandra R.
AU - Spencer, Alexandra J.
AU - Spina, Fernanda
AU - Spoors, Louise
AU - Stafford, Lizzie
AU - Stamford, Imogen
AU - Starinskij, Igor
AU - Stein, Ricardo
AU - Steven, Jill
AU - Stockdale, Lisa
AU - Stockwell, Lisa V.
AU - Strickland, Louise H.
AU - Stuart, Arabella C.
AU - Sturdy, Ann
AU - Sutton, Natalina
AU - Szigeti, Anna
AU - Tahiri-Alaoui, Abdessamad
AU - Tanner, Rachel
AU - Taoushanis, Carol
AU - Tarr, Alexander W.
AU - Taylor, Keja
AU - Taylor, Ursula
AU - Taylor, Iona Jennifer
AU - Taylor, Justin
AU - te Water Naude, Rebecca
AU - Themistocleous, Yrene
AU - Themistocleous, Andreas
AU - Thomas, Merin
AU - Thomas, Kelly
AU - Thomas, Tonia M.
AU - Thombrayil, Asha
AU - Thompson, Fawziyah
AU - Thompson, Amber
AU - Thompson, Kevin
AU - Thompson, Ameeka
AU - Thomson, Julia
AU - Thornton-Jones, Viv
AU - Tighe, Patrick J.
AU - Tinoco, Lygia Accioly
AU - Tiongson, Gerlynn
AU - Tladinyane, Bonolo
AU - Tomasicchio, Michele
AU - Tomic, Adriana
AU - Tonks, Susan
AU - Tran, Nguyen
AU - Tree, Julia
AU - Trillana, Gerry
AU - Trinham, Charlotte
AU - Trivett, Rose
AU - Truby, Adam
AU - Tsheko, Betty Lebogang
AU - Turabi, Aadil
AU - Turner, Richard
AU - Turner, Cheryl
AU - Ulaszewska, Marta
AU - Underwood, Benjamin R.
AU - Varughese, Rachel
AU - Verbart, Dennis
AU - Verheul, Marije
AU - Vichos, Iason
AU - Vieira, Taiane
AU - Waddington, Claire S.
AU - Walker, Laura
AU - Wallis, Erica
AU - Wand, Matthew
AU - Warbick, Deborah
AU - Wardell, Theresa
AU - Warimwe, George
AU - Warren, Sarah C.
AU - Watkins, Bridget
AU - Watson, Ekaterina
AU - Webb, Stewart
AU - Webb-Bridges, Alice
AU - Webster, Angela
AU - Welch, Jessica
AU - Wells, Jeanette
AU - West, Alison
AU - White, Caroline
AU - White, Rachel
AU - Williams, Paul
AU - Williams, Rachel L.
AU - Winslow, Rebecca
AU - Woodyer, Mark
AU - Worth, Andrew T.
AU - Wright, Danny
AU - Wroblewska, Marzena
AU - Yao, Andy
AU - Zimmer, Rafael
AU - Zizi, Dalila
AU - Zuidewind, Peter
PY - 2021
DA - January
TI - Safety and efficacy of the ChAdOx1 nCoV-19 vaccine (AZD1222) against SARS-CoV-2: an interim analysis of four randomised controlled trials in Brazil, South Africa, and the UK
JO - The Lancet
EP - 111
VL - 397
IS - 10269
DO - http://dx.doi.org/10.1016/S0140-6736(20)32661-1
AB - Background: A safe and efficacious vaccine against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), if deployed with high coverage, could contribute to the control of the COVID-19 pandemic. We evaluated the safety and efficacy of the ChAdOx1 nCoV-19 vaccine in a pooled interim analysis of four trials. Methods: This analysis includes data from four ongoing blinded, randomised, controlled trials done across the UK, Brazil, and South Africa. Participants aged 18 years and older were randomly assigned (1:1) to ChAdOx1 nCoV-19 vaccine or control (meningococcal group A, C, W, and Y conjugate vaccine or saline). Participants in the ChAdOx1 nCoV-19 group received two doses containing 5 × 1010 viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort). The primary efficacy analysis included symptomatic COVID-19 in seronegative participants with a nucleic acid amplification test-positive swab more than 14 days after a second dose of vaccine. Participants were analysed according to treatment received, with data cutoff on Nov 4, 2020. Vaccine efficacy was calculated as 1 - relative risk derived from a robust Poisson regression model adjusted for age. Studies are registered at ISRCTN89951424 and ClinicalTrials.gov, NCT04324606, NCT04400838, and NCT04444674. Findings: Between April 23 and Nov 4, 2020, 23 848 participants were enrolled and 11 636 participants (7548 in the UK, 4088 in Brazil) were included in the interim primary efficacy analysis. In participants who received two standard doses, vaccine efficacy was 62·1% (95% CI 41·0–75·7; 27 [0·6%] of 4440 in the ChAdOx1 nCoV-19 group vs71 [1·6%] of 4455 in the control group) and in participants who received a low dose followed by a standard dose, efficacy was 90·0% (67·4–97·0; three [0·2%] of 1367 vs 30 [2·2%] of 1374; pinteraction=0·010). Overall vaccine efficacy across both groups was 70·4% (95·8% CI 54·8–80·6; 30 [0·5%] of 5807 vs 101 [1·7%] of 5829). From 21 days after the first dose, there were ten cases hospitalised for COVID-19, all in the control arm; two were classified as severe COVID-19, including one death. There were 74 341 person-months of safety follow-up (median 3·4 months, IQR 1·3–4·8): 175 severe adverse events occurred in 168 participants, 84 events in the ChAdOx1 nCoV-19 group and 91 in the control group. Three events were classified as possibly related to a vaccine: one in the ChAdOx1 nCoV-19 group, one in the control group, and one in a participant who remains masked to group allocation. Interpretation: ChAdOx1 nCoV-19 has an acceptable safety profile and has been found to be efficacious against symptomatic COVID-19 in this interim analysis of ongoing clinical trials.
PB - Elsevier
UR - http://eprints.gla.ac.uk/227004/
KW - Coronavirus (COVID-19)
KW - Immunisation and screening
ER