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1. Complement lectin pathway activation is associated with COVID-19 disease severity, independent of MBL2 genotype subgroups

Author

Lisa Hurler, Ágnes Szilágyi, Federica Mescia, Laura Bergamaschi, Blanka Mező, György Sinkovits, Marienn Réti, Veronika Müller, Zsolt Iványi, János Gál, László Gopcsa, Péter Reményi, Beáta Szathmáry, Botond Lakatos, János Szlávik, Ilona Bobek, Zita Z. Prohászka, Zsolt Förhécz, Dorottya Csuka, Erika Kajdácsi, László Cervenak, Petra Kiszel, Tamás Masszi, István Vályi-Nagy, Reinhard Würzner, Cambridge Institute of Therapeutic Immunology and Infectious Disease-National Institute of Health Research (CITIID-NIHR) COVID BioResource Collaboration, Paul A. Lyons, Erik J. M. Toonen, Zoltán Prohászka, Stephen Baker, John R. Bradley, Patrick F. Chinnery, Daniel J. Cooper, Gordon Dougan, Ian G. Goodfellow, Ravindra K. Gupta, Nathalie Kingston, Paul J. Lehner, Nicholas J. Matheson, Caroline Saunders, Kenneth G. C. Smith, Charlotte Summers, James Thaventhiran, M. Estee Torok, Mark R. Toshner, Michael P. Weekes, Gisele Alvio, Sharon Baker, Areti Bermperi, Karen Brookes, Ashlea Bucke, Jo Calder, Laura Canna, Cherry Crucusio, Isabel Cruz, Rnalie de Jesus, Katie Dempsey, Giovanni Di Stephano, Jason Domingo, Anne Elmer, Julie Harris, Sarah Hewitt, Heather Jones, Sherly Jose, Jane Kennet, Yvonne King, Jenny Kourampa, Emily Li, Caroline McMahon, Anne Meadows, Vivien Mendoza, Criona O’Brien, Charmain Ocaya, Ciro Pascuale, Marlyn Perales, Jane Price, Rebecca Rastall, Carla Ribeiro, Jane Rowlands, Valentina Ruffolo, Hugo Tordesillas, Phoebe Vargas, Bensi Vergese, Laura Watson, Jieniean Worsley, Julie-Ann Zerrudo, Ariana Betancourt, Georgie Bower, Ben Bullman, Chiara Cossetti, Aloka De Sa, Benjamin J. Dunore, Maddie Epping, Stuart Fawke, Stefan Gräf, Richard Grenfell, Andrew Hinch, Josh Hodgson, Christopher Huang, Oisin Huhn, Kelvin Hunter, Isobel Jarvis, Emma Jones, Maša Josipović, Ekaterina Legchenko, Daniel Lewis, Joe Marsden, Jennifer Martin, Francesca Nice, Ciara O’Donnell, Ommar Omarjee, Marianne Perera, Linda Pointon, Nicole Pond, Nathan Richoz, Nika Romashova, Natalia Savoinykh, Rahul Sharma, Joy Shih, Mateusz Strezlecki, Rachel Sutcliffe, Tobias Tilly, Zhen Tong, Carmen Treacy, Lori Turner, Jennifer Wood, Marta Wylot, John Allison, Heather Biggs, Helen Butcher, Daniela Caputo, Debbie Clapham-Riley, Eleanor Dewhurst, Christian Fernandez, Anita Furlong, Barbara Graves, Jennifer Gray, Tasmin Ivers, Emma Le Gresley, Rachel Linger, Mary Kasanicki, Sarah Meloy, Francesca Muldoon, Nigel Ovington, Sofia Papadia, Christopher J. Penkett, Isabel Phelan, Venkatesh Ranganath, Jennifer Sambrook, Katherine Schon, Hannah Stark, Kathleen E. Stirrups, Paul Townsend, Julie von Ziegenweidt, Jennifer Webster, Ali Asaripour, Lucy Mwaura, Caroline Patterson, Gary Polwarth, Katherine Bunclark, Michael Mackay, Alice Michael, Sabrina Rossi, Mayurun Selvan, Sarah Spencer, Cissy Yong, and Petra Polgarova

Subjects
mannose binding lectin (MBL), MBL2 genotypes, COVID-19, severe acute respiratory coronavirus 2 (SARS-CoV-2), lectin pathway activation, lectin pathway of complement, Immunologic diseases. Allergy, RC581-607
Abstract

IntroductionWhile complement is a contributor to disease severity in severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections, all three complement pathways might be activated by the virus. Lectin pathway activation occurs through different pattern recognition molecules, including mannan binding lectin (MBL), a protein shown to interact with SARS-CoV-2 proteins. However, the exact role of lectin pathway activation and its key pattern recognition molecule MBL in COVID-19 is still not fully understood.MethodsWe therefore investigated activation of the lectin pathway in two independent cohorts of SARS-CoV-2 infected patients, while also analysing MBL protein levels and potential effects of the six major single nucleotide polymorphisms (SNPs) found in the MBL2 gene on COVID-19 severity and outcome.ResultsWe show that the lectin pathway is activated in acute COVID-19, indicated by the correlation between complement activation product levels of the MASP-1/C1-INH complex (p=0.0011) and C4d (p

Published
2023
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2. Distinction of early complement classical and lectin pathway activation via quantification of C1s/C1-INH and MASP-1/C1-INH complexes using novel ELISAs

Author

Lisa Hurler, Erik J. M. Toonen, Erika Kajdácsi, Bregje van Bree, Ricardo J. M. G. E. Brandwijk, Wieke de Bruin, Paul A. Lyons, Laura Bergamaschi, Cambridge Institute of Therapeutic Immunology and Infectious Disease-National Institute of Health Research (CITIID-NIHR) COVID BioResource Collaboration, György Sinkovits, László Cervenak, Reinhard Würzner, Zoltán Prohászka, Stephen Baker, John R. Bradley, Patrick F. Chinnery, Daniel J. Cooper, Gordon Dougan, Ian G. Goodfellow, Ravindra K. Gupta, Nathalie Kingston, Paul J. Lehner, Nicholas J. Matheson, Caroline Saunders, Kenneth G. C. Smith, Charlotte Summers, James Thaventhiran, M. Estee Torok, Mark R. Toshner, Michael P. Weekes, Gisele Alvio, Sharon Baker, Areti Bermperi, Karen Brookes, Ashlea Bucke, Jo Calder, Laura Canna, Cherry Crucusio, Isabel Cruz, Rnalie de Jesus, Katie Dempsey, Giovanni Di Stephano, Jason Domingo, Anne Elmer, Julie Harris, Sarah Hewitt, Heather Jones, Sherly Jose, Jane Kennet, Yvonne King, Jenny Kourampa, Emily Li, Caroline McMahon, Anne Meadows, Vivien Mendoza, Criona O’Brien, Charmain Ocaya, Ciro Pascuale, Marlyn Perales, Jane Price, Rebecca Rastall, Carla Ribeiro, Jane Rowlands, Valentina Ruffolo, Hugo Tordesillas, Phoebe Vargas, Bensi Vergese, Laura Watson, Jieniean Worsley, Julie-Ann Zerrudo, Ariana Betancourt, Georgie Bower, Ben Bullman, Chiara Cossetti, Aloka De Sa, Benjamin J. Dunore, Maddie Epping, Stuart Fawke, Stefan Gräf, Richard Grenfell, Andrew Hinch, Josh Hodgson, Christopher Huang, Oisin Huhn, Kelvin Hunter, Isobel Jarvis, Emma Jones, Maša Josipović, Ekaterina Legchenko, Daniel Lewis, Joe Marsden, Jennifer Martin, Federica Mescia, Francesca Nice, Ciara O’Donnell, Ommar Omarjee, Marianne Perera, Linda Pointon, Nicole Pond, Nathan Richoz, Nika Romashova, Natalia Savoinykh, Rahul Sharma, Joy Shih, Mateusz Strezlecki, Rachel Sutcliffe, Tobias Tilly, Zhen Tong, Carmen Treacy, Lori Turner, Jennifer Wood, Marta Wylot, John Allison, Heather Biggs, Helen Butcher, Daniela Caputo, Debbie Clapham-Riley, Eleanor Dewhurst, Christian Fernandez, Anita Furlong, Barbara Graves, Jennifer Gray, Tasmin Ivers, Emma Le Gresley, Rachel Linger, Mary Kasanicki, Sarah Meloy, Francesca Muldoon, Nigel Ovington, Sofia Papadia, Christopher J. Penkett, Isabel Phelan, Venkatesh Ranganath, Jennifer Sambrook, Katherine Schon, Hannah Stark, Kathleen E. Stirrups, Paul Townsend, Julie von Ziegenweidt, Jennifer Webster, Ali Asaripour, Lucy Mwaura, Caroline Patterson, Gary Polwarth, Katherine Bunclark, Michael Mackay, Alice Michael, Sabrina Rossi, Mayurun Selvan, Sarah Spencer, Cissy Yong, and Petra Polgarova

Subjects
early complement activation, classical pathway activation, lectin pathway activation, C1-INH complexes, assay development and validation, C1s/C1-INH complex, Immunologic diseases. Allergy, RC581-607
Abstract

The most commonly used markers to assess complement activation are split products that are produced through activation of all three pathways and are located downstream of C3. In contrast, C4d derives from the cleavage of C4 and indicates either classical (CP) or lectin pathway (LP) activation. Although C4d is perfectly able to distinguish between CP/LP and alternative pathway (AP) activation, no well-established markers are available to differentiate between early CP and LP activation. Active enzymes of both pathways (C1s/C1r for the CP, MASP-1/MASP-2 for the LP) are regulated by C1 esterase inhibitor (C1-INH) through the formation of covalent complexes. Aim of this study was to develop validated immunoassays detecting C1s/C1-INH and MASP-1/C1-INH complex levels. Measurement of the complexes reveals information about the involvement of the respective pathways in complement-mediated diseases. Two sandwich ELISAs detecting C1s/C1-INH and MASP-1/C1-INH complex were developed and tested thoroughly, and it was investigated whether C1s/C1-INH and MASP-1/C1-INH complexes could serve as markers for either early CP or LP activation. In addition, a reference range for these complexes in healthy adults was defined, and the assays were clinically validated utilizing samples of 414 COVID-19 patients and 96 healthy controls. The immunoassays can reliably measure C1s/C1-INH and MASP-1/C1-INH complex concentrations in EDTA plasma from healthy and diseased individuals. Both complex levels are increased in serum when activated with zymosan, making them suitable markers for early classical and early lectin pathway activation. Furthermore, measurements of C1-INH complexes in 96 healthy adults showed normally distributed C1s/C1-INH complex levels with a physiological concentration of 1846 ± 1060 ng/mL (mean ± 2SD) and right-skewed distribution of MASP-1/C1-INH complex levels with a median concentration of 36.9 (13.18 - 87.89) ng/mL (2.5-97.5 percentile range), while levels of both complexes were increased in COVID-19 patients (p

Published
2022
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3. Levels of soluble complement regulators predict severity of COVID-19 symptoms

Author

Anna L. Tierney, Wajd Mohammed Alali, Thomas Scott, Karen S. Rees-Unwin, CITIID-NIHR BioResource COVID-19 Collaboration, Simon J. Clark, Richard D. Unwin, Stephen Baker, John Bradley, Patrick Chinnery, Daniel Cooper, Gordon Dougan, Ian Goodfellow, Ravindra Gupta, Nathalie Kingston, Paul J. Lehner, Paul A. Lyons, Nicholas J. Matheson, Caroline Saunders, Kenneth G. C. Smith, Charlotte Summers, James Thaventhiran, M. Estee Torok, Mark R. Toshner, Michael P. Weekes, Gisele Alvio, Sharon Baker, Areti Bermperi, Karen Brookes, Ashlea Bucke, Jo Calder, Laura Canna, Cherry Crucusio, Isabel Cruz, Ranalie de Jesus, Katie Dempsey, Giovanni Di Stephano, Jason Domingo, Anne Elmer, Julie Harris, Sarah Hewitt, Heather Jones, Sherly Jose, Jane Kennet, Yvonne King, Jenny Kourampa, Emily Li, Caroline McMahon, Anne Meadows, Vivien Mendoza, Criona O’Brien, Charmain Ocaya, Ciro Pasquale, Marlyn Perales, Jane Price, Rebecca Rastall, Carla Ribeiro, Jane Rowlands, Valentina Ruffolo, Hugo Tordesillas, Phoebe Vargas, Bensi Vergese, Laura Watson, Jieniean Worsley, Julie-Ann Zerrudo, Laura Bergamashi, Ariana Betancourt, Georgie Bower, Ben Bullman, Chiara Cossetti, Aloka De Sa, Benjamin J. Dunmore, Maddie Epping, Stuart Fawke, Stefan Gräf, Richard Grenfell, Andrew Hinch, Josh Hodgson, Christopher Huang, Oisin Huhn, Kelvin Hunter, Isobel Jarvis, Emma Jones, Maša Josipović, Ekaterina Legchenko, Daniel Lewis, Joe Marsden, Jennifer Martin, Federica Mescia, Ciara O’Donnell, Ommar Omarjee, Marianne Perera, Linda Pointon, Nicole Pond, Nathan Richoz, Nika Romashova, Natalia Savoinykh, Rahul Sharma, Joy Shih, Mateusz Strezlecki, Rachel Sutcliffe, Tobias Tilly, Zhen Tong, Carmen Treacy, Lori Turner, Jennifer Wood, Marta Wylot, John Allison, Heather Biggs, John R. Bradley, Helen Butcher, Daniela Caputo, Matt Chandler, Debbie Clapham-Riley, Eleanor Dewhurst, Christian Fernandez, Anita Furlong, Barbara Graves, Jennifer Gray, Sabine Hein, Tasmin Ivers, Emma Le Gresley, Rachel Linger, Mary Kasanicki, Rebecca King, Sarah Meloy, Alexei Moulton, Francesca Muldoon, Nigel Ovington, Sofia Papadia, Christopher J. Penkett, Isabel Phelan, Venkatesh Ranganath, Roxana Paraschiv, Abigail Sage, Jennifer Sambrook, Ingrid Scholtes, Katherine Schon, Hannah Stark, Kathleen E. Stirrups, Paul Townsend, Neil Walker, Jennifer Webster, Mayurun Selvan, Petra Polgarova, Sarah L. Caddy, Laura G. Caller, Yasmin Chaudhry, Martin D. Curran, Theresa Feltwell, Stewart Fuller, Iliana Georgana, Grant Hall, William L. Hamilton, Myra Hosmillo, Charlotte J. Houldcroft, Rhys Izuagbe, Aminu S. Jahun, Fahad A. Khokhar, Anna G. Kovalenko, Luke W. Meredith, Surendra Parmar, Malte L. Pinckert, Anna Yakovleva, Emily C. Horner, Lucy Booth, Alexander Ferreira, Rebecca Boston, Robert Hughes, Juan Carlos Yam Puc, Nonantzin Beristain-Covarrubias, Maria Rust, Thevinya Gurugama, Lihinya Gurugama, Thomas Mulroney, Sarah Spencer, Zhaleh Hosseini, and Kate Williamson

Subjects
COVID-19, SARS-CoV-2, complement, factor H, factor H-related proteins, biomarkers, Immunologic diseases. Allergy, RC581-607
Abstract

The SARS-CoV-2 virus continues to cause significant morbidity and mortality worldwide from COVID-19. One of the major challenges of patient management is the broad range of symptoms observed. While the majority of individuals experience relatively mild disease, a significant minority of patients require hospitalisation, with COVID-19 still proving fatal for some. As such, there remains a desperate need to better understand what drives this severe disease, both in terms of the underlying biology, but also to potentially predict at diagnosis which patients are likely to require further interventions, thus enabling better outcomes for both patients and healthcare systems. Several lines of evidence have pointed to dysregulation of the complement cascade as a major factor in severe COVID-19 outcomes. How this is underpinned mechanistically is not known. Here, we have focussed on the role of the soluble complement regulators Complement Factor H (FH), its splice variant Factor H-like 1 (FHL-1) and five Factor H-Related proteins (FHR1-5). Using a targeted mass spectrometry approach, we quantified these proteins in a cohort of 188 plasma samples from controls and SARS-CoV-2 patients taken at diagnosis. This analysis revealed significant elevations in all FHR proteins, but not FH, in patients with more severe disease, particularly FHR2 and FHR5 (FHR2: 1.97-fold, p

Published
2022
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4. Combined Point-of-Care Nucleic Acid and Antibody Testing for SARS-CoV-2 following Emergence of D614G Spike Variant

Author

Petra Mlcochova, Dami Collier, Allyson Ritchie, Sonny M. Assennato, Myra Hosmillo, Neha Goel, Bo Meng, Krishna Chatterjee, Vivien Mendoza, Nigel Temperton, Leo Kiss, Leo C. James, Katarzyna A. Ciazynska, Xiaoli Xiong, John A.G. Briggs, James A. Nathan, Federica Mescia, Laura Bergamaschi, Hongyi Zhang, Petros Barmpounakis, Nikos Demeris, Richard Skells, Paul A. Lyons, John Bradley, Steven Baker, Jean Pierre Allain, Kenneth G.C. Smith, Rachel Bousfield, Michael Wilson, Dominic Sparkes, Glenn Amoroso, Effrosyni Gkrania-Klotsas, Susie Hardwick, Adrian Boyle, Ian Goodfellow, Ravindra K. Gupta, Stephen Baker, Gordon Dougan, Ravi Gupta, Paul J. Lehner, Paul Lyons, Nicholas J. Matheson, Mark Toshner, Michael P. Weekes, Nick Brown, Martin Curran, Surendra Palmar, David Enoch, Daniel Chapman, Ashley Shaw, Sherly Jose, Areti Bermperi, Julie Ann Zerrudo, Evgenia Kourampa, Laura Watson, Jieniean Worsley, Caroline Saunders, Ranalie de Jesus, Jason Domingo, Ciro Pasquale, Bensi Vergese, Phoebe Vargas, Marivic Fabiculana, Marlyn Perales, Lee Mynott, Elizabeth Blake, Amy Bates, Anne-Laure Vallier, Alexandra Williams, David Phillips, Edmund Chiu, Alex Overhill, Nicola Ramenatte, Jamal Sipple, Steven Frost, Helena Knock, Richard Hardy, Emily Foster, Fiona Davidson, Viona Rundell, Purity Bundi, Richmond Abeseabe, Sarah Clark, Isabel Vicente, Anne Elmer, Carla Ribeiro, Jenny Kourampa, Jane Kennet, Jane Rowlands, Anne Meadows, Criona O’Brien, Rebecca Rastall, Cherry Crucusio, Sarah Hewitt, Jane Price, Jo Calder, Laura Canna, Ashlea Bucke, Hugo Tordesillas, Julie Harris, Valentina Ruffolo, Barbara Graves, Helen Butcher, Daniela Caputo, Emma Le Gresley, Benjamin J. Dunmore, Jennifer Martin, Ekaterina Legchenko, Carmen Treacy, Christopher Huang, Jennifer Wood, Rachel Sutcliffe, Josh Hodgson, Joy Shih, Stefan Graf, Zhen Tong, Tobias Tilly, Ciara O’Donnell, Kelvin Hunter, Linda Pointon, Nicole Pond, Marta Wylot, Emma Jones, Stuart Fawke, Ben Bullman, Lori Turner, Isobel Jarvis, Ommar Omarjee, Aloka De Sa, Joe Marsden, Ariana Betancourt, Marianne Perera, Maddie Epping, Nathan Richoz, Georgie Bower, Rahul Sharma, Francesca Nice, Oisin Huhn, Natalia Savoinykh Yarkoni, Nika Romashova, Daniel Lewis, Andrew Hinch, Chiara Cossetti, Mateusz Strezlecki, Richard Grenfell, Hannah Stark, Neil Walker, Kathy Stirrups, Nigel Ovington, Eleanor Dewhust, Emily Li, Sofia Papadia, Nathalie Kingston, Andrew Lever, Estee Torok, William Hamilton, Grant Hall, Aminu Jahun, Yasmin Chaudhry, Malte Pinckert, Iliana Georgana, Anna Yakovleva, Laura Caller, Sarah Caddy, Theresa Feltwell, Fahad Khokhar, Luke Meredith, Charlotte Holdcroft, and Surendra Parmar

Subjects
SARS-CoV-2, COVID-19, rapid diagnoses, point of care testing, D614G, Medicine (General), R5-920
Abstract

Summary: Rapid COVID-19 diagnosis in the hospital is essential, although this is complicated by 30%–50% of nose/throat swabs being negative by SARS-CoV-2 nucleic acid amplification testing (NAAT). Furthermore, the D614G spike mutant dominates the pandemic and it is unclear how serological tests designed to detect anti-spike antibodies perform against this variant. We assess the diagnostic accuracy of combined rapid antibody point of care (POC) and nucleic acid assays for suspected COVID-19 disease due to either wild-type or the D614G spike mutant SARS-CoV-2. The overall detection rate for COVID-19 is 79.2% (95% CI 57.8–92.9) by rapid NAAT alone. The combined point of care antibody test and rapid NAAT is not affected by D614G and results in very high sensitivity for COVID-19 diagnosis with very high specificity.

Published
2020
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5. Point of Care Nucleic Acid Testing for SARS-CoV-2 in Hospitalized Patients: A Clinical Validation Trial and Implementation Study

Author

Dami A. Collier, Sonny M. Assennato, Ben Warne, Nyarie Sithole, Katherine Sharrocks, Allyson Ritchie, Pooja Ravji, Matthew Routledge, Dominic Sparkes, Jordan Skittrall, Anna Smielewska, Isobel Ramsey, Neha Goel, Martin Curran, David Enoch, Rhys Tassell, Michelle Lineham, Devan Vaghela, Clare Leong, Hoi Ping Mok, John Bradley, Kenneth G.C. Smith, Vivienne Mendoza, Nikos Demiris, Martin Besser, Gordon Dougan, Paul J. Lehner, Mark J. Siedner, Hongyi Zhang, Claire S. Waddington, Helen Lee, Ravindra K. Gupta, Stephen Baker, Ian Goodfellow, Paul Lyons, Nicholas J. Matheson, Mark Toshner, Michael P. Weekes, Nick Brown, Surendra Palmar, Daniel Chapman, Ashley Shaw, Vivien Mendoza, Sherly Jose, Areti Bermperi, Julie Ann Zerrudo, Evgenia Kourampa, Caroline Saunders, Ranalie de Jesus, Jason Domingo, Ciro Pasquale, Bensi Vergese, Phoebe Vargas, Marivic Fabiculana, Marlyn Perales, Richard Skells, Lee Mynott, Elizabeth Blake, Amy Bates, Anne-laure Vallier, Alexandra Williams, David Phillips, Edmund Chiu, Alex Overhill, Nicola Ramenante, Jamal Sipple, Steven Frost, Helena Knock, Richard Hardy, Emily Foster, Fiona Davidson, Viona Rundell, Purity Bundi, Richmond Abeseabe, Sarah Clark, and Isabel Vicente

Subjects
COVID-19, SARS-CoV-2, POC, point of care, diagnostic test, nosocomial, Medicine (General), R5-920
Abstract

Summary: There is an urgent need for rapid SARS-CoV-2 testing in hospitals to limit nosocomial spread. We report an evaluation of point of care (POC) nucleic acid amplification testing (NAAT) in 149 participants with parallel combined nasal and throat swabbing for POC versus standard lab RT-PCR testing. Median time to result is 2.6 (IQR 2.3–4.8) versus 26.4 h (IQR 21.4–31.4, p < 0.001), with 32 (21.5%) positive and 117 (78.5%) negative. Cohen’s κ correlation between tests is 0.96 (95% CI 0.91–1.00). When comparing nearly 1,000 tests pre- and post-implementation, the median time to definitive bed placement from admission is 23.4 (8.6-41.9) versus 17.1 h (9.0–28.8), p = 0.02. Mean length of stay on COVID-19 “holding” wards is 58.5 versus 29.9 h (p < 0.001). POC testing increases isolation room availability, avoids bed closures, allows discharge to care homes, and expedites access to hospital procedures. POC testing could mitigate the impact of COVID-19 on hospital systems.

Published
2020
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6. COVID-19 vaccine-induced antibody responses in immunosuppressed patients with inflammatory bowel disease (VIP): a multicentre, prospective, case-control study

Author

James L Alexander, Nicholas A Kennedy, Hajir Ibraheim, Sulak Anandabaskaran, Aamir Saifuddin, Rocio Castro Seoane, Zhigang Liu, Rachel Nice, Claire Bewshea, Andrea D'Mello, Laura Constable, Gareth R Jones, Sharmili Balarajah, Francesca Fiorentino, Shaji Sebastian, Peter M Irving, Lucy C Hicks, Horace R T Williams, Alexandra J Kent, Rachel Linger, Miles Parkes, Klaartje Kok, Kamal V Patel, Julian P Teare, Daniel M Altmann, Rosemary J Boyton, James R Goodhand, Ailsa L Hart, Charlie W Lees, Tariq Ahmad, Nick Powell, Ijeoma Chukwurah, Sulaimaan Haq, Parita Shah, Stephanie Wilken-Smith, Anitha Ramanathan, Mikin Patel, Lidia Romanczuk, Rebecca King, Jason Domingo, Djamila Shamtally, Vivien Mendoza, Joanne Sanchez, Hannah Stark, Bridget Knight, Louise Bee, Charmaine Estember, Anna Barnes, Darcy Watkins, Sam Stone, John Kirkwood, Marian Parkinson, Helen Gardner-Thorpe, Kate Covil, Lauranne Derikx, Beatriz Gros Alcalde, Irish Lee, Bessie Cipriano, Giuseppe Ruocco, Manisha Baden, Graham Cooke, Katrina Pollock, Freed Foundation, Imperial College Healthcare NHS Trust- BRC Funding, National Institute for Health Research, Bewshea, Claire [0000-0002-0965-9587], Jones, Gareth R [0000-0001-7355-2357], and Apollo - University of Cambridge Repository

Subjects
Adult, COVID-19 Vaccines, VIP study investigators, Adolescent, Hepatology, SARS-CoV-2, COVID-19/prevention & control, Gastroenterology, COVID-19, Articles, Inflammatory Bowel Diseases, Inflammatory Bowel Diseases/drug therapy, Case-Control Studies, ChAdOx1 nCoV-19, Antibody Formation, Humans, Prospective Studies, Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5], BNT162 Vaccine
Abstract

Contains fulltext : 288037.pdf (Publisher’s version ) (Closed access) BACKGROUND: The effects that therapies for inflammatory bowel disease (IBD) have on immune responses to SARS-CoV-2 vaccination are not yet fully known. Therefore, we sought to determine whether COVID-19 vaccine-induced antibody responses were altered in patients with IBD on commonly used immunosuppressive drugs. METHODS: In this multicentre, prospective, case-control study (VIP), we recruited adults with IBD treated with one of six different immunosuppressive treatment regimens (thiopurines, infliximab, a thiopurine plus infliximab, ustekinumab, vedolizumab, or tofacitinib) and healthy control participants from nine centres in the UK. Eligible participants were aged 18 years or older and had received two doses of COVID-19 vaccines (either ChAdOx1 nCoV-19 [Oxford-AstraZeneca], BNT162b2 [Pfizer-BioNTech], or mRNA1273 [Moderna]) 6-12 weeks apart (according to scheduling adopted in the UK). We measured antibody responses 53-92 days after a second vaccine dose using the Roche Elecsys Anti-SARS-CoV-2 spike electrochemiluminescence immunoassay. The primary outcome was anti-SARS-CoV-2 spike protein antibody concentrations in participants without previous SARS-CoV-2 infection, adjusted by age and vaccine type, and was analysed by use of multivariable linear regression models. This study is registered in the ISRCTN Registry, ISRCTN13495664, and is ongoing. FINDINGS: Between May 31 and Nov 24, 2021, we recruited 483 participants, including patients with IBD being treated with thiopurines (n=78), infliximab (n=63), a thiopurine plus infliximab (n=72), ustekinumab (n=57), vedolizumab (n=62), or tofacitinib (n=30), and 121 healthy controls. We included 370 participants without evidence of previous infection in our primary analysis. Geometric mean anti-SARS-CoV-2 spike protein antibody concentrations were significantly lower in patients treated with infliximab (156·8 U/mL [geometric SD 5·7]; p

Published
2022

7. COVID-19 vaccine-induced antibody and T-cell responses in immunosuppressed patients with inflammatory bowel disease after the third vaccine dose (VIP): a multicentre, prospective, case-control study

Author

James L Alexander, Zhigang Liu, Diana Muñoz Sandoval, Catherine Reynolds, Hajir Ibraheim, Sulak Anandabaskaran, Aamir Saifuddin, Rocio Castro Seoane, Nikhil Anand, Rachel Nice, Claire Bewshea, Andrea D'Mello, Laura Constable, Gareth R Jones, Sharmili Balarajah, Francesca Fiorentino, Shaji Sebastian, Peter M Irving, Lucy C Hicks, Horace R T Williams, Alexandra J Kent, Rachel Linger, Miles Parkes, Klaartje Kok, Kamal V Patel, Julian P Teare, Daniel M Altmann, James R Goodhand, Ailsa L Hart, Charlie W Lees, Rosemary J Boyton, Nicholas A Kennedy, Tariq Ahmad, Nick Powell, Ijeoma Chukwurah, Sulaimaan Haq, Parita Shah, Stephanie Wilken-Smith, Anitha Ramanathan, Mikin Patel, Lidia Romanczuk, Rebecca King, Jason Domingo, Djamila Shamtally, Vivien Mendoza, Joanne Sanchez, Hannah Stark, Bridget Knight, Louise Bee, Charmaine Estember, Anna Barnes, Darcy Watkins, Sam Stone, John Kirkwood, Marian Parkinson, Helen Gardner-Thorpe, Kate Covil, Lauranne Derikx, Beatriz Gros Alcalde, Irish Lee, Bessie Cipriano, Giuseppe Ruocco, Manisha Baden, Graham Cooke, Katrina Pollock, Evgenia Kourampa, Ciro Pasquale, Elena Robisco-Diaz, Suhaylah Bhatti, Joyce and Norman Freed Charitable Trust, Pfizer Limited, Medical Research Council (MRC), Alexander, James L [0000-0001-8542-327X], Powell, Nick [0000-0003-3231-6950], and Apollo - University of Cambridge Repository

Subjects
COVID-19 Vaccines, VIP study investigators, Hepatology, SARS-CoV-2, T-Lymphocytes, Gastroenterology, COVID-19, Antibodies, Viral, Inflammatory Bowel Diseases, Infliximab, Case-Control Studies, Humans, Janus Kinase Inhibitors, Tumor Necrosis Factor Inhibitors, Ustekinumab, Prospective Studies, Immunosuppressive Agents, Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5]
Abstract

Contains fulltext : 288038.pdf (Publisher’s version ) (Open Access) BACKGROUND: COVID-19 vaccine-induced antibody responses are reduced in patients with inflammatory bowel disease (IBD) taking anti-TNF or tofacitinib after two vaccine doses. We sought to assess whether immunosuppressive treatments were associated with reduced antibody and T-cell responses in patients with IBD after a third vaccine dose. METHODS: VIP was a multicentre, prospective, case-control study done in nine centres in the UK. We recruited immunosuppressed patients with IBD and non-immunosuppressed healthy individuals. All participants were aged 18 years or older. The healthy control group had no diagnosis of IBD and no current treatment with systemic immunosuppressive therapy for any other indication. The immunosuppressed patients with IBD had an established diagnosis of Crohn's disease, ulcerative colitis, or unclassified IBD using standard definitions of IBD, and were receiving established treatment with one of six immunosuppressive regimens for at least 12 weeks at the time of first dose of SARS-CoV-2 vaccination. All participants had to have received three doses of an approved COVID-19 vaccine. SARS-CoV-2 spike antibody binding and T-cell responses were measured in all participant groups. The primary outcome was anti-SARS-CoV-2 spike (S1 receptor binding domain [RBD]) antibody concentration 28-49 days after the third vaccine dose, adjusted by age, homologous versus heterologous vaccine schedule, and previous SARS-CoV-2 infection. The primary outcome was assessed in all participants with available data. FINDINGS: Between Oct 18, 2021, and March 29, 2022, 352 participants were included in the study (thiopurine n=65, infliximab n=46, thiopurine plus infliximab combination therapy n=49, ustekinumab n=44, vedolizumab n=50, tofacitinib n=26, and healthy controls n=72). Geometric mean anti-SARS-CoV-2 S1 RBD antibody concentrations increased in all groups following a third vaccine dose, but were significantly lower in patients treated with infliximab (2736·8 U/mL [geometric SD 4·3]; p

Published
2022

8. Infliximab and Tofacitinib Attenuate Neutralizing Antibody Responses Against SARS-CoV-2 Ancestral and Omicron Variants in Inflammatory Bowel Disease Patients After 3 Doses of COVID-19 Vaccine

Author

Zhigang Liu, James L. Alexander, Kathy Weitung Lin, Tariq Ahmad, Katrina M. Pollock, Nick Powell, Kaixing Le, Xin Zhou, Hajir Ibraheim, Sulak Anandabaskaran, Aamir Saifuddin, Leon R. McFarlane, Nikhil Anand, Laura Constable, Rocio Castro Seoane, Andrea D’Mello, Sharmili Balarajah, Lucy C. Hicks, Horace R.T. Williams, Jonathan W. Lo, Ailsa L. Hart, Daniel M. Altmann, Rosemary J. Boyton, Julian P. Teare, Rachel Nice, Claire Bewshea, James R. Goodhand, Nicholas A. Kennedy, Anna Barnes, John Kirkwood, Marian Parkinson, Helen Gardner-Thorpe, Charlie W. Lees, Gareth R. Jones, Kate Covil, Lauranne Derikx, Francesca Fiorentino, Peter M. Irving, Miles Parkes, Rachel Linger, Klaartje Kok, Irish Lee, Bessie Cipriano, Kamal V. Patel, Shaji Sebastian, Alexandra J. Kent, Ijeoma Chukwurah, Sulaimaan Haq, Parita Shah, Stephanie Wilken-Smith, Anitha Ramanathan, Mikin Patel, Lidia Romanczuk, Rebecca King, Jason Domingo, Bridget Knight, Djamila Shamtally, Vivien Mendoza, Joanne Sanchez, Hannah Stark, Louise Bee, Charmaine Estember, Darcy Watkins, Sam Stone, Beatriz Gros Alcalde, Giuseppe Ruocco, Manisha Baden, Graham Cooke, Evgenia Kourampa, Ciro Pasquale, Elena Robisco-Diaz, and Suhaylah Bhatti

Subjects
Hepatology, Gastroenterology, Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5]
Abstract

Contains fulltext : 291656.pdf (Publisher’s version ) (Open Access)

Published
2023

9. Challenges and opportunities for conducting a vaccine trial during the COVID-19 pandemic in the United Kingdom

Author

M Estée Török, Benjamin R Underwood, Mark Toshner, Claire Waddington, Emad Sidhom, Katherine Sharrocks, Rachel Bousfield, Charlotte Summers, Caroline Saunders, Zoe McIntyre, Helen Morris, Jo Piper, Gloria Calderon, Sarah Dennis, Tracy Assari, Anita Marguerie de Rotrou, Ashley Shaw, John Bradley, John O’Brien, Robert C Rintoul, Ian Smith, Ed Bullmore, Krishna Chatterjee, Carla Ribeiro, Lorinda Pickup, Ranalie de Jesus, Karen Brookes, Phoebe Vargas, Caroline McMahon, Chiara Macor, Ciro Pasquale, Areti Bermperi, Evgenia Kourampa, Marivic Fabiculcana, Julie Ann Zerudo, Vivien Mendoza, Stewart Fuller, Claire Glemas, Sharon Baker, Greta Lyons, Marina Bishop, Siobhan Coleman, Naomi Thomas, Vince Mlilo, Edward Stanton, Rachel Michel, Julie Philips, Heidi Rice, Lucie Garner, Francesca Rosa, Saji Victor, Julie Zamikula, Sue Mepham, Fatima Hajee, Juan Carlos Quijano-Campos, Laura Watson, Christopher Georgiou, Jieniean Worsley, Djamilla Shamtally-Amode, Ferishta Rahimi, Heather Jones, Isabel Cruz, Gayle Lindsay, Christian Sparke, Anna Chapman, Katie Keating-Fedders, Codie Fahey, Danielle Johnson, Lucy Worboys, Simone Hargreaves, Ashlea Bucke, Lindsay Carr, Jackie Hampshire, Tracy Richardson, Jenny Sharpe, Lynne Whitehead, Naval Vyse, Stephen Kelleher, Mary-Beth Sherwood, Vicki Hughes, Kim Giraud, Török, M Estée [0000-0001-9098-8590], and Apollo - University of Cambridge Repository

Subjects
medicine.medical_specialty, COVID-19 Vaccines, Design, Best practice, coronavirus, 01 natural sciences, State Medicine, 010104 statistics & probability, 03 medical and health sciences, 0302 clinical medicine, vaccine, Political science, Pandemic, medicine, Humans, 030212 general & internal medicine, 0101 mathematics, Pandemics, Pharmacology, Clinical Trials as Topic, Medical education, SARS-CoV-2, business.industry, pandemic, Public health, Teleconference, Vaccine trial, COVID-19, Information technology, clinical trial, General Medicine, Project team, United Kingdom, 3. Good health, Clinical trial, business
Abstract

The COVID-19 pandemic has resulted in unprecedented challenges for healthcare systems worldwide. It has also stimulated research in a wide range of areas including rapid diagnostics, novel therapeutics, use of technology to track patients and vaccine development. Here, we describe our experience of rapidly setting up and delivering a novel COVID-19 vaccine trial, using clinical and research staff and facilities in three National Health Service Trusts in Cambridgeshire, United Kingdom. We encountered and overcame a number of challenges including differences in organisational structures, research facilities available, staff experience and skills, information technology and communications infrastructure, and research training and assessment procedures. We overcame these by setting up a project team that included key members from all three organisations that met at least daily by teleconference. This group together worked to identify the best practices and procedures and to harmonise and cascade these to the wider trial team. This enabled us to set up the trial within 25 days and to recruit and vaccinate the participants within a further 23 days. The lessons learned from our experiences could be used to inform the conduct of clinical trials during a future infectious disease pandemic or public health emergency.

Published
2021

10. Combined point-of-care nucleic acid and antibody testing for SARS-CoV-2 following emergence of D614G spike variant

Author

Petra Mlcochova, Dami Collier, Allyson Ritchie, Sonny M. Assennato, Myra Hosmillo, Neha Goel, Bo Meng, Krishna Chatterjee, Vivien Mendoza, Nigel Temperton, Leo Kiss, Leo C. James, Katarzyna A. Ciazynska, Xiaoli Xiong, John A.G. Briggs, James A. Nathan, Federica Mescia, Laura Bergamaschi, Hongyi Zhang, Petros Barmpounakis, Nikos Demeris, Richard Skells, Paul A. Lyons, John Bradley, Steven Baker, Jean Pierre Allain, Kenneth G.C. Smith, Rachel Bousfield, Michael Wilson, Dominic Sparkes, Glenn Amoroso, Effrosyni Gkrania-Klotsas, Susie Hardwick, Adrian Boyle, Ian Goodfellow, Ravindra K. Gupta, Stephen Baker, Gordon Dougan, Ravi Gupta, Paul J. Lehner, Paul Lyons, Nicholas J. Matheson, Mark Toshner, Michael P. Weekes, Nick Brown, Martin Curran, Surendra Palmar, David Enoch, Daniel Chapman, Ashley Shaw, Sherly Jose, Areti Bermperi, Julie Ann Zerrudo, Evgenia Kourampa, Laura Watson, Jieniean Worsley, Caroline Saunders, Ranalie de Jesus, Jason Domingo, Ciro Pasquale, Bensi Vergese, Phoebe Vargas, Marivic Fabiculana, Marlyn Perales, Lee Mynott, Elizabeth Blake, Amy Bates, Anne-Laure Vallier, Alexandra Williams, David Phillips, Edmund Chiu, Alex Overhill, Nicola Ramenatte, Jamal Sipple, Steven Frost, Helena Knock, Richard Hardy, Emily Foster, Fiona Davidson, Viona Rundell, Purity Bundi, Richmond Abeseabe, Sarah Clark, Isabel Vicente, Anne Elmer, Carla Ribeiro, Jenny Kourampa, Jane Kennet, Jane Rowlands, Anne Meadows, Criona O’Brien, Rebecca Rastall, Cherry Crucusio, Sarah Hewitt, Jane Price, Jo Calder, Laura Canna, Ashlea Bucke, Hugo Tordesillas, Julie Harris, Valentina Ruffolo, Barbara Graves, Helen Butcher, Daniela Caputo, Emma Le Gresley, Benjamin J. Dunmore, Jennifer Martin, Ekaterina Legchenko, Carmen Treacy, Christopher Huang, Jennifer Wood, Rachel Sutcliffe, Josh Hodgson, Joy Shih, Stefan Graf, Zhen Tong, Tobias Tilly, Ciara O’Donnell, Kelvin Hunter, Linda Pointon, Nicole Pond, Marta Wylot, Emma Jones, Stuart Fawke, Ben Bullman, Lori Turner, Isobel Jarvis, Ommar Omarjee, Aloka De Sa, Joe Marsden, Ariana Betancourt, Marianne Perera, Maddie Epping, Nathan Richoz, Georgie Bower, Rahul Sharma, Francesca Nice, Oisin Huhn, Natalia Savoinykh Yarkoni, Nika Romashova, Daniel Lewis, Andrew Hinch, Chiara Cossetti, Mateusz Strezlecki, Richard Grenfell, Hannah Stark, Neil Walker, Kathy Stirrups, Nigel Ovington, Eleanor Dewhust, Emily Li, Sofia Papadia, Nathalie Kingston, Andrew Lever, Estee Torok, William Hamilton, Grant Hall, Aminu Jahun, Yasmin Chaudhry, Malte Pinckert, Iliana Georgana, Anna Yakovleva, Laura Caller, Sarah Caddy, Theresa Feltwell, Fahad Khokhar, Luke Meredith, Charlotte Holdcroft, and Surendra Parmar

Subjects
Male, Antibodies, Viral, Serology, 0302 clinical medicine, COVID-19 Testing, 80 and over, Medicine, 030212 general & internal medicine, Viral, Aged, 80 and over, Immunoassay, 0303 health sciences, lcsh:R5-920, biology, Middle Aged, D614G, Spike Glycoprotein, 3. Good health, medicine.anatomical_structure, Point-of-Care Testing, Spike Glycoprotein, Coronavirus, Spike (software development), Female, Antibody, lcsh:Medicine (General), Nucleic Acid Amplification Techniques, Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), Point-of-care testing, Sensitivity and Specificity, General Biochemistry, Genetics and Molecular Biology, Antibodies, 03 medical and health sciences, rapid diagnoses, Neutralization Tests, Throat, Report, Humans, 030304 developmental biology, Point of care, Aged, QR355, COVID-19, point of care testing, SARS-CoV-2, business.industry, Virology, Coronavirus, biology.protein, Nucleic acid, business
Abstract

Rapid COVID-19 diagnosis in the hospital is essential, although this is complicated by 30%–50% of nose/throat swabs being negative by SARS-CoV-2 nucleic acid amplification testing (NAAT). Furthermore, the D614G spike mutant dominates the pandemic and it is unclear how serological tests designed to detect anti-spike antibodies perform against this variant. We assess the diagnostic accuracy of combined rapid antibody point of care (POC) and nucleic acid assays for suspected COVID-19 disease due to either wild-type or the D614G spike mutant SARS-CoV-2. The overall detection rate for COVID-19 is 79.2% (95% CI 57.8–92.9) by rapid NAAT alone. The combined point of care antibody test and rapid NAAT is not affected by D614G and results in very high sensitivity for COVID-19 diagnosis with very high specificity., Graphical Abstract, Highlights Combined rapid antibody + nucleic acid detection correctly diagnoses SARS-CoV-2 Rapid antibody tests detect immune responses against SARS-CoV-2 bearing D614G Rapid SARS-CoV-2 antibody tests do not cross-react with antibodies to seasonal CoV False positivity in SARS-CoV-2 finger prick blood antibody tests can be very low, Mlcochova et al. report that combined rapid nucleic acid amplification testing (NAAT) and finger prick blood antibody tests can substantially improve the diagnosis of COVID-19 as compared to NAAT alone and is able to detect the SARS-CoV-2 Spike D614G variant that dominates the pandemic.

Published
2021

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