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1. Incidental findings in UK healthy volunteers screened for a COVID‐19 vaccine trial

Author

Susanne H. Hodgson, Poppy Iveson, Jessica Larwood, Sophie Roche, Hazel Morrison, Catherine Cosgrove, Eva Galiza, Sabina Ikram, Nana‐Marie Lemm, Savviz Mehdipour, Daniel Owens, Mihaela Pacurar, Michael Schumacher, Robert H. Shaw, Saul N. Faust, Paul T. Heath, Andrew J. Pollard, Katherine R. W. Emary, Katrina M. Pollock, and Rajeka Lazarus

Subjects
Therapeutics. Pharmacology, RM1-950, Public aspects of medicine, RA1-1270
Abstract

Abstract The safety of novel therapeutics and vaccines are typically assessed in early phase clinical trials involving “healthy volunteers.” Abnormalities in such individuals can be difficult to interpret and may indicate previously unrecognized medical conditions. The frequency of incidental findings (IFs) in healthy volunteers who attend for clinical trial screening is unclear. To assess this, we retrospectively analyzed data for 1838 “healthy volunteers” screened for enrolment in a UK multicenter, phase I/II severe acute respiratory syndrome‐coronavirus 2 (SARS‐COV‐2) vaccine trial. Participants were predominantly White (89.7%, 1640/1828) with a median age of 34 years (interquartile range [IQR] = 27–44). There were 27.7% of participants (510/1838) who had at least one IF detected. The likelihood of identifying evidence of a potential, new blood‐borne virus infection was low (1 in 238 participants) compared with identification of an elevated alanine transaminase (ALT; 1 in 17 participants). A large proportion of participants described social habits that could impact negatively on their health; 21% consumed alcohol in excess, 10% were current smokers, 11% described recreational drug use, and only 48% had body weight in the ideal range. Our data demonstrate that screening prior to enrollment in early phase clinical trials identifies a range of IFs, which should inform discussion during the consent process. Greater clarity is needed to ensure an appropriate balance is struck between early identification of medical problems and avoidance of exclusion of volunteers due to spurious or physiological abnormalities. Debate should inform the role of the trial physician in highlighting and advising about unhealthy social habits.

Published
2022
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2. Safety, immunogenicity, and efficacy of a COVID-19 vaccine (NVX-CoV2373) co-administered with seasonal influenza vaccines: an exploratory substudy of a randomised, observer-blinded, placebo-controlled, phase 3 trial

Author

Seth Toback, Eva Galiza, Catherine Cosgrove, James Galloway, Anna L Goodman, Pauline A Swift, Sankarasubramanian Rajaram, Alison Graves-Jones, Jonathan Edelman, Fiona Burns, Angela M Minassian, Iksung Cho, Lakshmi Kumar, Joyce S Plested, E Joy Rivers, Andreana Robertson, Filip Dubovsky, Greg Glenn, Paul T Heath, Roy L. Soiza, Robin Brittain-Long, Chiara Scicluna, Carole Edwards, Lynn Mackay, Mariella D'Allesandro, Amy Nicol, Karen Norris, Sandra Mann, Heather Lawrence, Ruth Valentine, Marianne Elizabeth Viljoen, Carol H. Pretswell, Helen Nicholls, Imrozia Munsoor, Agnieszka Meyrick, Christina Kyriakidou, Shalini Iyengar, Arham Jamal, Nick Richards, Helen Price, Bridie Rowbotham, Danielle Bird, Karen Smith, Olga Littler, Kirsty Fielding, Anna Townsend-Rose, Karen Miller, Jessica Davis, Alison Elliot-Garwood, Lauren Trottier, Paul Edwards, Margaret McFarland, Orod Osanlou, Laura Longshaw, Jane Stockport, Lynne Grundy, Katharine Lucy Broad, Karen Regan, Kim Storton, Declan Ryan-Wakeling, Brad Wilson, Malathy Munisamy, John Wright, Anil Shenoy, Beverley English, Lucy Brear, Paola Cicconi, Marta Boffito, Ana Milinkovic, Ruth Byrne, Roya Movahedi, Rosalie Housman, Naveed Kara, Ellen Brown, Andrea Cipriani, Mary-Jane Attenburrow, Katharine A. Smith, Jonathan Packham, Geoff Sparrow, Richard Smith, Josephine M. Rosier, Khalid Saja, Nyasha Nago, Brian Camilleri, Anita Immanuel, Mike Hamblin, Rawlings Osagie, Mahalakshmi Mohan, Hilary Floyd, Suzanne Goddard, Sanjay Mutgi, John Evans, Sean McKeon, Neringa Vilimiene, Rosavic Chicano, Rachel Hayre, Alice Pandaan, Catherine Henshall, Sonia Serrano, Andrea Mazzella, Thurkka Rajeswaran, Moncy Mathew, Karen Bisnauthsing, Laura Bremner, Henry Fok, Franca Morselli, Paola Cinardo, Blair Merrick, Lucy Sowole, Samantha Broadhead, Natalie Palmer, Jessica Cordle, Jaimie Wilson Goldsmith, Enya Cooney, Beth Jackson, Thilina Jayatilleke, Zelda Cheng, Toby Helliwell, Adrian Chudyk, Rafaela Giemza, John Lord Villajin, Noah Yogo, Esther Makanju, Pearl Dulawan, Deepak Nagra, April Buazon, Alice Russell, Georgie Bird, Amardeep Heer, Rex Sarmiento, Balraj Sanghera, Melanie Mullin, Adam Champion, Aisling Bevan, Kinzah Iqbal, Alshia Johnson, Rebecca Clark, Sarah Shaw, Steven Shaw, Amanda Chalk, Martin Lovatt, Caroline Lillicrap, Angela Parker, Jan Hansel, Zhi Wong, Galvin Gan, Eyad Tuma, Jane Minton, Jennifer Murira, Razan Saman, Alistair Hall, Kyra Holliday, Zara Khan, James Calderwood, George Twigg, Helena Baker, Julie Corrigan, Katy Houseman, Subhra Raguvanshi, Dominic Heining, Jake Weddell, Liz Glaves, Kim Thompson, Francis Davies, Ruth Lambley Burke, Emma C. Thomson, Dinesh Saralaya, Lisa Berry, Nancy Hopewell, Leigh Gerdes, Mihaela Pacurar, Saul N. Faust, Jeremy Turner, Christopher Jeanes, Adele Cooper, Jocelyn Keshet-Price, Lou Coke, Melissa Cambell-Kelly, Ketan Dhatariya, Claire Williams, Georgina Marks, James Sudbury, Lisa Rodolico, Judy Bradley, Sharon Carr, Roisin Martin, Angelina Madden, Paul Biagioni, Sonia McKenna, Alison Clinton, Maurice O'Kane, Justin Carter, Matthew Dewhurst, Bill Wetherill, Thandiwe Hoggarth, Katrina Lennon Collins, Marie Chowdhury, Adil Nathoo, Anna Heinen, Orla MacDonald, Claudia Hurducas, Liliana Cifuentes, Harjeevan Gill, Andy Gibson, Raha West, Jane Ewing, Rachel Blacow, John Haughney, Jonathan MacDonald, John Paul Seenan, Stewart Webb, Colin O'Leary, Scott Muir, Beth White, Neil Ritchie, Daniel F. McAuley, Jonathan Stewart, Mariella D'Alessandro, Nicki Lakeman, Laura Purandare, Duncan Browne, David Tucker, Peter Luck, Angharad Everden, Lisa Trembath, Michael Visick, Nick Morley, Laura Reid, Helen Chenoweth, Kirsty Maclean, Ray P. Sheridan, Tom Burden, Craig Francis Lunt, Shirley Todd, Stephanie Estcourt, Jasmine Marie Pearce, Suzanne Wilkins, Cathryn Love-Rouse, Eva Torok-Pollok, Mike Youle, Sara Madge, Danielle Solomon, Aarti Nandani, Janet M. North, Nargis Hemat, Rachel Newport, Philip A. Kalra, Chukwuma Chukwu, Olivia Wickens, Vikki O'Loughlin, Hema Mistry, Louise Harrison, Robert Oliver, Anne-Marie Peers, Jess Zadik, Katie Doyle, David R. Chadwick, Kerry Colling, Caroline Wroe, Marie Branch, Alison Chilvers, Sarah Essex, Mark Stone, Alberto San Francisco Ramos, Emily Beales, Olivia Bird, Zsofia Danos, Hazel Fofie, Cecilia Hultin, Sabina Ikram, Fran Mabesa, Aoife Mescall, Josyanne Pereira, Jennifer Pearce, Natalina Sutton, Emma Snashall, David Neil Baxter, Sara Bennett, Debbie Suggitt, Kerry Hughes, Wiesia Woodyatt, Lynsey Beacon, Alissa Kent, Chris Cooper, Milan Rudic, Simon Tunstall, Matthew Jackson, Claire Hombersley, Patrick Moore, Rebecca Cutts, Andrew Higham, Marwan Bukhari, Mohamed Elnaggar, Michelle Glover, Fiona Richardson, Alexandra Dent, Shahzeb Mirza, Rajiv Ark, Jennie Han, Suzy V. Hope, Philip J. Mitchelmore, Rostam Osanlou, Andrew Freedman, Alison Cooper, Katherine Burton, Kashyap Katechia, Michael Barrett, Jo Salkeld, Natalie Hill, Nathaniel Lee, Jon Perkins, and Polly Fox

Subjects
Adult, Pulmonary and Respiratory Medicine, Trivalent influenza vaccine, medicine.medical_specialty, COVID-19 Vaccines, Adolescent, Influenza vaccine, Population, Placebo, Young Adult, Immunogenicity, Vaccine, Double-Blind Method, Internal medicine, Humans, Medicine, education, Adverse effect, Aged, education.field_of_study, Reactogenicity, SARS-CoV-2, business.industry, COVID-19, Articles, Middle Aged, Vaccine efficacy, Vaccination, Influenza Vaccines, Seasons, business
Abstract

Background The safety and immunogenicity profile of COVID-19 vaccines when administered concomitantly with seasonal influenza vaccines have not yet been reported. We therefore aimed to report the results of a substudy within a phase 3 UK trial, by evaluating the safety, immunogenicity, and efficacy of NVX-CoV2373 when co-administered with licensed seasonal influenza vaccines. Methods We did a planned exploratory substudy as part of the randomised, observer-blinded, placebo-controlled, phase 3 trial of the safety and efficacy of the COVID-19 vaccine (NVX-CoV2373) by co-administrating the influenza vaccine at four study hospitals in the UK. Approximately, the first 400 participants meeting the main study entry criteria—with no contraindications to influenza vaccination—were invited to join the substudy. Participants of the main study were randomly assigned (1:1) to receive two intramuscular injections of either NVX-CoV2373 (5 μg) or placebo (normal saline) 21 days apart; participants enrolled into the substudy were co-vaccinated with a single (0·5 mL) intramuscular, age-appropriate (quadrivalent influenza cell-based vaccine [Flucelvax Quadrivalent; Seqirus UK, Maidenhead] for those aged 18–64 years and adjuvanted trivalent influenza vaccine [Fluad; Seqirus UK, Maidenhead] for those ≥65 years), licensed, influenza vaccine on the opposite deltoid to that of the first study vaccine dose or placebo. The influenza vaccine was administered in an open-label manner and at the same time as the first study injection. Reactogenicity was evaluated via an electronic diary for 7 days after vaccination in addition to monitoring for unsolicited adverse events, medically attended adverse events, and serious adverse events. Immunogenicity was assessed with influenza haemagglutination inhibition and SARS-CoV-2 anti-spike protein IgG assays. Vaccine efficacy against PCR-confirmed, symptomatic COVID-19 was assessed in participants who were seronegative at baseline, received both doses of study vaccine or placebo, had no major protocol deviations affecting the primary endpoint, and had no confirmed cases of symptomatic COVID-19 from the first dose until 6 days after the second dose (per-protocol efficacy population). Immunogenicity was assessed in participants who received scheduled two doses of study vaccine, had a baseline sample and at least one post-vaccination sample, and had no major protocol violations before unmasking (per-protocol immunogenicity population). Reactogenicity was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo and had data collected for reactogenicity events. Safety was analysed in all participants who received at least one dose of NVX-CoV2373 or placebo. Comparisons were made between participants of the substudy and the main study (who were not co-vaccinated for influenza). This study is registered with ClinicalTrials.gov, number NCT04583995. Findings Between Sept 28, 2020, and Nov 28, 2020, a total of 15 187 participants were randomised into the main phase 3 trial, of whom 15 139 received treatment (7569 received dose one of NVX-CoV2373 and 7570 received dose one of placebo). 431 participants were co-vaccinated with a seasonal influenza vaccine in the substudy (217 received NVX-CoV2373 plus the influenza vaccine and 214 received placebo plus the influenza vaccine). In general, the substudy participants were younger, more racially diverse, and had fewer comorbid conditions than those in the main study. Reactogenicity events were more common in the co-administration group than in the NVX-CoV2373 alone group: tenderness (113 [64·9%] of 174 vs 592 [53·3%] of 1111) or pain (69 [39·7%] vs 325 [29·3%]) at injection site, fatigue (48 [27·7%] vs 215 [19·4%]), and muscle pain (49 [28·3%] vs 237 [21·4%]). Incidences of unsolicited adverse events, treatment-related medically attended adverse events, and serious adverse events were low and balanced between the co-administration group and the NVX-CoV2373 alone group. No episodes of anaphylaxis or deaths were reported within the substudy. Co-administration resulted in no change to influenza vaccine immune response although a reduction in antibody responses to the NVX-CoV2373 vaccine was noted. NVX-CoV2373 vaccine efficacy in the substudy (ie, participants aged 18 to

Published
2022

3. Comparing reactogenicity of COVID-19 vaccines: a systematic review and meta-analysis

Author

Natalina Sutton, Alberto San Francisco Ramos, Emily Beales, David Smith, Sabina Ikram, Eva Galiza, Yingfen Hsia, and Paul T. Heath

Subjects
Pharmacology, Adult, COVID-19 Vaccines, Adolescent, Immunology, COVID-19, reactogenicity, COVID-19 vaccines, adverse events, Meta-analysis, Adjuvants, Immunologic, Vaccines, Inactivated, SDG 3 - Good Health and Well-being, Drug Discovery, Systematic review, Molecular Medicine, Humans
Abstract

OBJECTIVES: A number of vaccines have now been developed against COVID-19. Differences in reactogenicity and safety profiles according to the vaccine technologies employed are becoming apparent from clinical trials. METHODS: Five databases (Medline, EMBASE, Science Citation Index, Cochrane Central Register of Controlled Trials, London School of Hygiene and Tropical Medicine COVID-19 vaccine tracker) were searched for relevant randomised controlled trials between 1 January 2020 and 12 January 2022 according to predetermined criteria with no language limitations. RESULTS: Forty-two datasets were identified, with 20 vaccines using four different technologies (viral vector, inactivated, mRNA and protein sub-unit). Adults and adolescents over 12 years were included. Control groups used saline placebos, adjuvants, and comparator vaccines. The most consistently reported solicited adverse events were fever, fatigue, headache, pain at injection site, redness, and swelling. Both doses of mRNA vaccines, the second dose of protein subunit and the first dose of adenovirus vectored vaccines were the most reactogenic, while the inactivated vaccines were the least reactogenic. CONCLUSIONS: The different COVID-19 vaccines currently available appear to have distinct reactogenicity profiles, dependent on the vaccine technology employed. Awareness of these differences may allow targeted recommendations for specific populations. Greater standardization of methods for adverse event reporting will aid future research in this field.

Published
2022

4. Incidental findings in UK healthy volunteers screened for a COVID‐19 vaccine trial

Author

Nana-Marie Lemm, Sabina Ikram, Jessica Poppy Jane Larwood, Katherine R. W. Emary, Saul N. Faust, Savviz Mehdipour, Rajeka Lazarus, Hazel Morrison, Robert Shaw, Michael Schumacher, Katarina M Pollock, Poppy Iveson, Paul T. Heath, Mihaela Pacurar, Eva P. Galiza, Daniel R Owens, Susanne H. Hodgson, Catherine Cosgrove, Sophie Roche, and Andrew J. Pollard

Subjects
Adult, Male, medicine.medical_specialty, COVID-19 Vaccines, Coronavirus disease 2019 (COVID-19), COVID-19/prevention & control, MEDLINE, RM1-950, Research & Experimental Medicine, General Biochemistry, Genetics and Molecular Biology, SARS-CoV-2/immunology, Article, Body Mass Index, Interquartile range, Internal medicine, Healthy volunteers, medicine, Humans, 1112 Oncology and Carcinogenesis, General Pharmacology, Toxicology and Pharmaceutics, Alanine Transaminase/blood, General Clinical Medicine, 1102 Cardiorespiratory Medicine and Haematology, Retrospective Studies, Incidental Findings, Science & Technology, biology, business.industry, SARS-CoV-2, General Neuroscience, Research, Vaccine trial, COVID-19, Alanine Transaminase, General Medicine, Recreational drug use, Healthy Volunteers, Clinical trial, Alanine transaminase, Medicine, Research & Experimental, biology.protein, Female, Therapeutics. Pharmacology, COVID-19 Vaccines/immunology, Public aspects of medicine, RA1-1270, business, Life Sciences & Biomedicine, 1199 Other Medical and Health Sciences
Abstract

The safety of novel therapeutics and vaccines are typically assessed in early phase clinical trials involving “healthy volunteers.” Abnormalities in such individuals can be difficult to interpret and may indicate previously unrecognized medical conditions. The frequency of incidental findings (IFs) in healthy volunteers who attend for clinical trial screening is unclear. To assess this, we retrospectively analyzed data for 1838 “healthy volunteers” screened for enrolment in a UK multicenter, phase I/II severe acute respiratory syndrome‐coronavirus 2 (SARS‐COV‐2) vaccine trial. Participants were predominantly White (89.7%, 1640/1828) with a median age of 34 years (interquartile range [IQR] = 27–44). There were 27.7% of participants (510/1838) who had at least one IF detected. The likelihood of identifying evidence of a potential, new blood‐borne virus infection was low (1 in 238 participants) compared with identification of an elevated alanine transaminase (ALT; 1 in 17 participants). A large proportion of participants described social habits that could impact negatively on their health; 21% consumed alcohol in excess, 10% were current smokers, 11% described recreational drug use, and only 48% had body weight in the ideal range. Our data demonstrate that screening prior to enrollment in early phase clinical trials identifies a range of IFs, which should inform discussion during the consent process. Greater clarity is needed to ensure an appropriate balance is struck between early identification of medical problems and avoidance of exclusion of volunteers due to spurious or physiological abnormalities. Debate should inform the role of the trial physician in highlighting and advising about unhealthy social habits.

Published
2021

5. Training final year medical students in telephone communication and prioritization skills: An evaluation in the simulated environment

Author

Josephine Seale, Lewis Whittingham, Colin Butchers, Nicola Purkiss Bejarano, Sophie C Ragbourne, Sabina Ikram, and Ranjana Raj

Subjects
Adult, Male, Students, Medical, Medical psychology, 020205 medical informatics, education, MEDLINE, 02 engineering and technology, Training (civil), Session (web analytics), Education, law.invention, Task (project management), Young Adult, 03 medical and health sciences, Patient safety, 0302 clinical medicine, Randomized controlled trial, law, Surveys and Questionnaires, London, ComputingMilieux_COMPUTERSANDEDUCATION, 0202 electrical engineering, electronic engineering, information engineering, Humans, 030212 general & internal medicine, Curriculum, Physician-Patient Relations, Medical education, Communication, General Medicine, Telephone, Patient Simulation, Female, Triage, Psychology, Education, Medical, Undergraduate
Abstract

Introduction: Receiving clinical tasks via the telephone and correctly prioritizing job lists are integral to patient safety. However, structured training on these skills is currently lacking in many medical curriculums. This study evaluated the impact of telephone communication and prioritization training on the ability of final year medical students to carry out these skills during an on-call simulation. Methods: Twenty-five final year King's College London medical students underwent a training session focused on telephone communication and task prioritization (group A). The performance of group A students in an on-call simulation involving these tasks was compared with twenty-five untrained final year students (group B). All participants completed a questionnaire about their training and/or simulation experience. Results: Group A compared to B students asked for more task-related information during each simulated call and correctly prioritized the resultant job list on significantly more occasions. Significantly more group A students reported being confident in answering calls and prioritizing their lists. The majority of students supported the addition of telephone communication and prioritization training into the medical curriculum. Conclusions: This study demonstrates the educational benefit of structured teaching on the ability of final year medical students to receive telephone handovers and prioritize job lists.

Published
2019

6. 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

Author

Merryn Voysey, Sue Ann Costa Clemens, Shabir A Madhi, Lily Y Weckx, Pedro M Folegatti, Parvinder K Aley, Brian Angus, Vicky L Baillie, Shaun L Barnabas, Qasim E Bhorat, Sagida Bibi, Carmen Briner, Paola Cicconi, Andrea M Collins, Rachel Colin-Jones, Clare L Cutland, Thomas C Darton, Keertan Dheda, Christopher J A Duncan, Katherine R W Emary, Katie J Ewer, Lee Fairlie, Saul N Faust, Shuo Feng, Daniela M Ferreira, Adam Finn, Anna L Goodman, Catherine M Green, Christopher A Green, Paul T Heath, Catherine Hill, Helen Hill, Ian Hirsch, Susanne H C Hodgson, Alane Izu, Susan Jackson, Daniel Jenkin, Carina C D Joe, Simon Kerridge, Anthonet Koen, Gaurav Kwatra, Rajeka Lazarus, Alison M Lawrie, Alice Lelliott, Vincenzo Libri, Patrick J Lillie, Raburn Mallory, Ana V A Mendes, Eveline P Milan, Angela M Minassian, Alastair McGregor, Hazel Morrison, Yama F Mujadidi, Anusha Nana, Peter J O’Reilly, Sherman D Padayachee, Ana Pittella, Emma Plested, Katrina M Pollock, Maheshi N Ramasamy, Sarah Rhead, Alexandre V Schwarzbold, Nisha Singh, Andrew Smith, Rinn Song, Matthew D Snape, Eduardo Sprinz, Rebecca K Sutherland, Richard Tarrant, Emma C Thomson, M Estée Török, Mark Toshner, David P J Turner, Johan Vekemans, Tonya L Villafana, Marion E E Watson, Christopher J Williams, Alexander D Douglas, Adrian V S Hill, Teresa Lambe, Sarah C Gilbert, Andrew J Pollard, Marites Aban, Fatola Abayomi, Kushala Abeyskera, Jeremy Aboagye, Matthew Adam, Kirsty Adams, James Adamson, Yemi A. Adelaja, Gbadebo Adewetan, Syed Adlou, Khatija Ahmed, Yasmeen Akhalwaya, Saajida Akhalwaya, Andrew Alcock, Aabidah Ali, Elizabeth R. Allen, Lauren Allen, Thamires C. D. S. C Almeida, Mariana P.S. Alves, Fabio Amorim, Foteini Andritsou, Rachel Anslow, Matthew Appleby, Edward H. Arbe-Barnes, Mark P. Ariaans, Beatriz Arns, Laiana Arruda, Paula Azi, Lorena Azi, Gavin Babbage, Catherine Bailey, Kenneth F. Baker, Megan Baker, Natalie Baker, Philip Baker, Lisa Baldwin, Ioana Baleanu, Danieli Bandeira, Anna Bara, Marcella A.S. Barbosa, Debbie Barker, Gavin D. Barlow, Eleanor Barnes, Andrew S. Barr, Jordan R. Barrett, Jessica Barrett, Louise Bates, Alexander Batten, Kirsten Beadon, Emily Beales, Rebecca Beckley, Sandra Belij-Rammerstorfer, Jonathan Bell, Duncan Bellamy, Nancy Bellei, Sue Belton, Adam Berg, Laura Bermejo, Eleanor Berrie, Lisa Berry, Daniella Berzenyi, Amy Beveridge, Kevin R. Bewley, Helen Bexhell, Sutika Bhikha, Asad E. Bhorat, Zaheda E. Bhorat, Else Bijker, Geeta Birch, Sarah Birch, Adam Bird, Olivia Bird, Karen Bisnauthsing, Mustapha Bittaye, Katherine Blackstone, Luke Blackwell, Heather Bletchly, Caitlin L. Blundell, Susannah R. Blundell, Pritesh Bodalia, Bruno C. Boettger, Emma Bolam, Elena Boland, Daan Bormans, Nicola Borthwick, Francesca Bowring, Amy Boyd, Penny Bradley, Tanja Brenner, Phillip Brown, Claire Brown, Charlie Brown-O'Sullivan, Scott Bruce, Emily Brunt, Ruaridh Buchan, William Budd, Yusuf A. Bulbulia, Melanie Bull, Jamie Burbage, Hassan Burhan, Aileen Burn, Karen R. Buttigieg, Nicholas Byard, Ingrid Cabera Puig, Gloria Calderon, Anna Calvert, Susana Camara, Michelangelo Cao, Federica Cappuccini, João R. Cardoso, Melanie Carr, Miles W. Carroll, Andrew Carson-Stevens, Yasmin de M. Carvalho, José A.M. Carvalho, Helen R. Casey, Paul Cashen, Thais Castro, Lucia Carratala Castro, Katrina Cathie, Ana Cavey, José Cerbino-Neto, Jim Chadwick, David Chapman, Sue Charlton, Irina Chelysheva, Oliver Chester, Sunder Chita, Jee-Sun Cho, Liliana Cifuentes, Elizabeth Clark, Matthew Clark, Andrea Clarke, Elizabeth A. Clutterbuck, Sarah L.K. Collins, Christopher P. Conlon, Sean Connarty, Naomi Coombes, Cushla Cooper, Rachel Cooper, Lynne Cornelissen, Tumena Corrah, Catherine Cosgrove, Tony Cox, Wendy E.M. Crocker, Sarah Crosbie, Lorraine Cullen, Dan Cullen, Debora R.M.F. Cunha, Christina Cunningham, Fiona C. Cuthbertson, Suzete N. Farias Da Guarda, Larissa P. da Silva, Brad E. Damratoski, Zsofia Danos, Maria T.D.C. Dantas, Paula Darroch, Mehreen S. Datoo, Chandrabali Datta, Malika Davids, Sarah L. Davies, Hannah Davies, Elizabeth Davis, Judith Davis, John Davis, Maristela M.D. De Nobrega, Lis Moreno De Oliveira Kalid, David Dearlove, Tesfaye Demissie, Amisha Desai, Stefania Di Marco, Claudio Di Maso, Maria I.S. Dinelli, Tanya Dinesh, Claire Docksey, Christina Dold, Tao Dong, Francesca R. Donnellan, Tannyth Dos Santos, Thainá G. dos Santos, Erika Pachecho Dos Santos, Naomi Douglas, Charlotte Downing, Jonathan Drake, Rachael Drake-Brockman, Kimberley Driver, Ruth Drury, Susanna J. Dunachie, Benjamin S. Durham, Lidiana Dutra, Nicholas J.W. Easom, Samual van Eck, Mandy Edwards, Nick J. Edwards, Omar M. El Muhanna, Sean C. Elias, Mike Elmore, Marcus English, Alisgair Esmail, Yakub Moosa Essack, Eoghan Farmer, Mutjaba Farooq, Madi Farrar, Leonard Farrugia, Beverley Faulkner, Sofiya Fedosyuk, Sally Felle, Carla Ferreira Da Silva, Samantha Field, Richard Fisher, Amy Flaxman, James Fletcher, Hazel Fofie, Henry Fok, Karen J. Ford, Jamie Fowler, Pedro H.A. Fraiman, Emma Francis, Marilia M. Franco, John Frater, Marilúcia S.M. Freire, Samantha H. Fry, Sabrina Fudge, Julie Furze, Michelle Fuskova, Pablo Galian-Rubio, Eva Galiza, Harriet Garlant, Madita Gavrila, Ailsa Geddes, Karyna A. Gibbons, Ciaran Gilbride, Hardeep Gill, Sharon Glynn, Kerry Godwin, Karishma Gokani, Ursula Carvalho Goldoni, Maria Goncalves, Isabela G.S. Gonzalez, Jayne Goodwin, Amina Goondiwala, Katherine Gordon-Quayle, Giacomo Gorini, Janet Grab, Lara Gracie, Melanie Greenland, Nicola Greenwood, Johann Greffrath, Marisa M. Groenewald, Leonardo Grossi, Gaurav Gupta, Mark Hackett, Bassam Hallis, Mainga Hamaluba, Elizabeth Hamilton, Joseph Hamlyn, Daniel Hammersley, Aidan T. Hanrath, Brama Hanumunthadu, Stephanie A. Harris, Clair Harris, Tara Harris, Thomas D. Harrison, Daisy Harrison, Thomas C. Hart, Birgit Hartnell, Shadin Hassan, John Haughney, Sophia Hawkins, Jodie Hay, Ian Head, John Henry, Macarena Hermosin Herrera, David B. Hettle, Jennifer Hill, Gina Hodges, Elizea Horne, Mimi M. Hou, Catherine Houlihan, Elizabeth Howe, Nicola Howell, Jonathan Humphreys, Holly E. Humphries, Katrina Hurley, Claire Huson, Angela Hyder-Wright, Catherine Hyams, Sabina Ikram, Alka Ishwarbhai, Monica Ivan, Poppy Iveson, Vidyashankara Iyer, Frederic Jackson, Jeanne De Jager, Shameem Jaumdally, Helen Jeffers, Natasha Jesudason, Bryony Jones, Kathryn Jones, Elizabeth Jones, Christopher Jones, Marianna Rocha Jorge, Aylin Jose, Amar Joshi, Eduardo A.M.S. Júnior, Joanne Kadziola, Reshma Kailath, Faeeza Kana, Konstantinos Karampatsas, Mwila Kasanyinga, Jade Keen, Elizabeth J. Kelly, Dearbhla M. Kelly, Debbie Kelly, Sarah Kelly, David Kerr, Renato de Ávila Kfouri, Liaquat Khan, Baktash Khozoee, Sarah Kidd, Annabel Killen, Jasmin Kinch, Patrick Kinch, Lloyd D.W. King, Thomas B. King, Lucy Kingham, Paul Klenerman, Francesca Knapper, Julian C. Knight, Daniel Knott, Stanislava Koleva, Matilda Lang, Gail Lang, Colin W. Larkworthy, Jessica P.J. Larwood, Rebecca Law, Erica M. Lazarus, Amanda Leach, Emily A. Lees, Nana-Marie Lemm, Alvaro Lessa, Stephanie Leung, Yuanyuan Li, Amelia M. Lias, Kostas Liatsikos, Aline Linder, Samuel Lipworth, Shuchang Liu, Xinxue Liu, Adam Lloyd, Stephanie Lloyd, Lisa Loew, Raquel Lopez Ramon, Leandro Lora, Vicki Lowthorpe, Kleber Luz, Jonathan C. MacDonald, Gordon MacGregor, Meera Madhavan, David O. Mainwaring, Edson Makambwa, Rebecca Makinson, Mookho Malahleha, Ross Malamatsho, Garry Mallett, Kushal Mansatta, Takalani Maoko, Katlego Mapetla, Natalie G. Marchevsky, Spyridoula Marinou, Emma Marlow, Gabriela N. Marques, Paula Marriott, Richard P. Marshall, Julia L. Marshall, Flávia J. Martins, Masebole Masenya, Mduduzi Masilela, Shauna K. Masters, Moncy Mathew, Hosea Matlebjane, Kedidimetse Matshidiso, Olga Mazur, Andrea Mazzella, Hugh McCaughan, Joanne McEwan, Joanna McGlashan, Lorna McInroy, Zoe McIntyre, Daniela McLenaghan, Nicky McRobert, Steve McSwiggan, Clare Megson, Savviz Mehdipour, Wilma Meijs, Renata N.Á. Mendonça, Alexander J. Mentzer, Neginsadat Mirtorabi, Celia Mitton, Sibusiso Mnyakeni, Fiona Moghaddas, Kgaogelo Molapo, Mapule Moloi, Maria Moore, M. Isabel Moraes-Pinto, Marni Moran, Ella Morey, Róisín Morgans, Susan Morris, Sheila Morris, Helen C. Morris, Franca Morselli, Gertraud Morshead, Richard Morter, Lynelle Mottal, Andrew Moultrie, Nathifa Moya, Mushiya Mpelembue, Sibekezelo Msomi, Yvonne Mugodi, Ekta Mukhopadhyay, Jilly Muller, Alasdair Munro, Claire Munro, Sarah Murphy, Philomena Mweu, Celia Hatsuko Myasaki, Gurudutt Naik, Kush Naker, Eleni Nastouli, Abida Nazir, Bongani Ndlovu, Fabio Neffa, Cecilia Njenga, Helena Noal, Andrés Noé, Gabrielle Novaes, Fay L. Nugent, Géssika Nunes, Katie O'Brien, Daniel O'Connor, Miranda Odam, Suzette Oelofse, Blanche Oguti, Victoria Olchawski, Neil J. Oldfield, Marianne G. Oliveira, Catarina Oliveira, Angela Oosthuizen, Paula O'Reilly, Piper Osborne, David R.J. Owen, Lydia Owen, Daniel Owens, Nelly Owino, Mihaela Pacurar, Brenda V.B. Paiva, Edna M.F. Palhares, Susan Palmer, Sivapriyai Parkinson, Helena M.R.T. Parracho, Karen Parsons, Dipak Patel, Bhumika Patel, Faeezah Patel, Kelly Patel, Maia Patrick-Smith, Ruth O. Payne, Yanchun Peng, Elizabeth J. Penn, Anna Pennington, Marco Polo Peralta Alvarez, James Perring, Nicola Perry, Rubeshan Perumal, Sahir Petkar, Tricia Philip, Daniel J. Phillips, Jennifer Phillips, Mary Kgomotso Phohu, Lorinda Pickup, Sonja Pieterse, Jo Piper, Dimitra Pipini, Mary Plank, Joan Du Plessis, Samuel Pollard, Jennifer Pooley, Anil Pooran, Ian Poulton, Claire Powers, Fernando B. Presa, David A. Price, Vivien Price, Marcelo Primeira, Pamela C. Proud, Samuel Provstgaard-Morys, Sophie Pueschel, David Pulido, Sheena Quaid, Ria Rabara, Alexandra Radford, Kajal Radia, Durga Rajapaska, Thurkka Rajeswaran, Alberto San Francisco Ramos, Fernando Ramos Lopez, Tommy Rampling, Jade Rand, Helen Ratcliffe, Tom Rawlinson, David Rea, Byron Rees, Jesús Reiné, Mila Resuello-Dauti, Emilia Reyes Pabon, Carla M. Ribiero, Marivic Ricamara, Alex Richter, Neil Ritchie, Adam J. Ritchie, Alexander J. Robbins, Hannah Roberts, Ryan E. Robinson, Hannah Robinson, Talita T. Rocchetti, Beatriz Pinho Rocha, Sophie Roche, Christine Rollier, Louisa Rose, Amy L. Ross Russell, Lindie Rossouw, Simon Royal, Indra Rudiansyah, Sarah Ruiz, Stephen Saich, Claudia Sala, Jessica Sale, Ahmed M. Salman, Natalia Salvador, Stephannie Salvador, Milla Sampaio, Annette D. Samson, Amada Sanchez-Gonzalez, Helen Sanders, Katherine Sanders, Erika Santos, Mayara F.S. Santos Guerra, Iman Satti, Jack E. Saunders, Caroline Saunders, Aakifah Sayed, Ina Schim van der Loeff, Annina B. Schmid, Ella Schofield, Gavin Screaton, Samiullah Seddiqi, Rameswara R. Segireddy, Roberta Senger, Sonia Serrano, Rajiv Shah, Imam Shaik, Hannah E. Sharpe, Katherine Sharrocks, Robert Shaw, Adam Shea, Amy Shepherd, James G. Shepherd, Farah Shiham, Emad Sidhom, Sarah E. Silk, Antonio Carlos da Silva Moraes, Gilberto Silva-Junior, Laura Silva-Reyes, Anderson D. Silveira, Mariana B.V. Silveira, Jaisi Sinha, Donal T. Skelly, Daniel C. Smith, Nick Smith, Holly E. Smith, David J. Smith, Catherine C. Smith, Airanuédida Soares, Tiago Soares, Carla Solórzano, Guilherme L. Sorio, Kim Sorley, Tiffany Sosa-Rodriguez, Cinthia M.C.D.L. Souza, Bruno S.D.F. Souza, Alessandra R. Souza, Alexandra J. Spencer, Fernanda Spina, Louise Spoors, Lizzie Stafford, Imogen Stamford, Igor Starinskij, Ricardo Stein, Jill Steven, Lisa Stockdale, Lisa V. Stockwell, Louise H. Strickland, Arabella C. Stuart, Ann Sturdy, Natalina Sutton, Anna Szigeti, Abdessamad Tahiri-Alaoui, Rachel Tanner, Carol Taoushanis, Alexander W. Tarr, Keja Taylor, Ursula Taylor, Iona Jennifer Taylor, Justin Taylor, Rebecca te Water Naude, Yrene Themistocleous, Andreas Themistocleous, Merin Thomas, Kelly Thomas, Tonia M. Thomas, Asha Thombrayil, Fawziyah Thompson, Amber Thompson, Kevin Thompson, Ameeka Thompson, Julia Thomson, Viv Thornton-Jones, Patrick J. Tighe, Lygia Accioly Tinoco, Gerlynn Tiongson, Bonolo Tladinyane, Michele Tomasicchio, Adriana Tomic, Susan Tonks, James Towner, Nguyen Tran, Julia Tree, Gerry Trillana, Charlotte Trinham, Rose Trivett, Adam Truby, Betty Lebogang Tsheko, Aadil Turabi, Richard Turner, Cheryl Turner, Marta Ulaszewska, Benjamin R. Underwood, Rachel Varughese, Dennis Verbart, Marije Verheul, Iason Vichos, Taiane Vieira, Claire S. Waddington, Laura Walker, Erica Wallis, Matthew Wand, Deborah Warbick, Theresa Wardell, George Warimwe, Sarah C. Warren, Bridget Watkins, Ekaterina Watson, Stewart Webb, Alice Webb-Bridges, Angela Webster, Jessica Welch, Jeanette Wells, Alison West, Caroline White, Rachel White, Paul Williams, Rachel L. Williams, Rebecca Winslow, Mark Woodyer, Andrew T. Worth, Danny Wright, Marzena Wroblewska, Andy Yao, Rafael Zimmer, Dalila Zizi, Peter Zuidewind, Group, Oxford COVID Vaccine Trial, Toshner, Mark [0000-0002-3969-6143], and Apollo - University of Cambridge Repository

Subjects
Male, COVID-19/prevention & control, 030204 cardiovascular system & hematology, law.invention, South Africa, 0302 clinical medicine, Randomized controlled trial, law, Oxford COVID Vaccine Trial Group, wc_505, Single-Blind Method, 030212 general & internal medicine, Young adult, 11 Medical and Health Sciences, wa_105, Covid19, General Medicine, Articles, Middle Aged, Treatment Outcome, Cohort, Perspective, Female, Brazil, Adult, medicine.medical_specialty, COVID-19 Vaccines, Adolescent, qw_806, qw_805, 03 medical and health sciences, Young Adult, Double-Blind Method, Conjugate vaccine, Internal medicine, General & Internal Medicine, ChAdOx1 nCoV-19, medicine, Humans, Adverse effect, Aged, business.industry, SARS-CoV-2, COVID-19, Viral Vaccines, Vaccine efficacy, Interim analysis, United Kingdom, Clinical trial, bf023de6, business, COVID-19 Vaccines/adverse effects
Abstract

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. \ud \ud \ud 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. \ud \ud \ud 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. \ud \ud \ud 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. \ud \ud \ud FUNDING: UK Research and Innovation, National Institutes for Health Research (NIHR), Coalition for Epidemic Preparedness Innovations, Bill & Melinda Gates Foundation, Lemann Foundation, Rede D'Or, Brava and Telles Foundation, NIHR Oxford Biomedical Research Centre, Thames Valley and South Midland's NIHR Clinical Research Network, and AstraZeneca.

Published
2020

8. Safety and immunogenicity of the ChAdOx1 nCoV-19 vaccine against SARS-CoV-2: a preliminary report of a phase 1/2, single-blind, randomised controlled trial

Author

Pedro M Folegatti, Katie J Ewer, Parvinder K Aley, Brian Angus, Stephan Becker, Sandra Belij-Rammerstorfer, Duncan Bellamy, Sagida Bibi, Mustapha Bittaye, Elizabeth A Clutterbuck, Christina Dold, Saul N Faust, Adam Finn, Amy L Flaxman, Bassam Hallis, Paul Heath, Daniel Jenkin, Rajeka Lazarus, Rebecca Makinson, Angela M Minassian, Katrina M Pollock, Maheshi Ramasamy, Hannah Robinson, Matthew Snape, Richard Tarrant, Merryn Voysey, Catherine Green, Alexander D Douglas, Adrian V S Hill, Teresa Lambe, Sarah C Gilbert, Andrew J Pollard, Jeremy Aboagye, Kelly Adams, Aabidah Ali, Elizabeth Allen, Jennifer L. Allison, Rachel Anslow, Edward H. Arbe-Barnes, Gavin Babbage, Kenneth Baillie, Megan Baker, Natalie Baker, Philip Baker, Ioana Baleanu, Juliana Ballaminut, Eleanor Barnes, Jordan Barrett, Louise Bates, Alexander Batten, Kirsten Beadon, Rebecca Beckley, Eleanor Berrie, Lisa Berry, Amy Beveridge, Kevin R. Bewley, Else Margreet Bijker, Tracey Bingham, Luke Blackwell, Caitlin L. Blundell, Emma Bolam, Elena Boland, Nicola Borthwick, Thomas Bower, Amy Boyd, Tanja Brenner, Philip D. Bright, Charlie Brown-O'Sullivan, Emily Brunt, Jamie Burbage, Sharon Burge, Karen R. Buttigieg, Nicholas Byard, Ingrid Cabera Puig, Anna Calvert, Susana Camara, Michelangelo Cao, Federica Cappuccini, Melanie Carr, Miles W. Carroll, Victoria Carter, Katrina Cathie, Ruth J. Challis, Sue Charlton, Irina Chelysheva, Jee-Sun Cho, Paola Cicconi, Liliana Cifuentes, Helen Clark, Elizabeth Clark, Tom Cole, Rachel Colin-Jones, Christopher P. Conlon, Aislinn Cook, Naomi S. Coombes, Rachel Cooper, Catherine A. Cosgrove, Karen Coy, Wendy E.M. Crocker, Christina J. Cunningham, Brad E. Damratoski, Lynne Dando, Mehreen S. Datoo, Hannah Davies, Hans De Graaf, Tesfaye Demissie, Claudio Di Maso, Isabelle Dietrich, Tao Dong, Francesca R. Donnellan, Naomi Douglas, Charlotte Downing, Jonathan Drake, Rachael Drake-Brockman, Ruth Elizabeth Drury, Susanna Jane Dunachie, Nick J. Edwards, Frances D.L. Edwards, Chris J. Edwards, Sean C. Elias, Michael J. Elmore, Katherine R.W. Emary, Marcus Rex English, Susanne Fagerbrink, Sally Felle, Shuo Feng, Samantha Field, Carine Fixmer, Clare Fletcher, Karen J. Ford, Jamie Fowler, Polly Fox, Emma Francis, John Frater, Julie Furze, Michelle Fuskova, Eva Galiza, Diane Gbesemete, Ciaran Gilbride, Kerry Godwin, Giacomo Gorini, Lyndsey Goulston, Caroline Grabau, Lara Gracie, Zoe Gray, Lucy Belle Guthrie, Mark Hackett, Sandro Halwe, Elizabeth Hamilton, Joseph Hamlyn, Brama Hanumunthadu, Irasha Harding, Stephanie A. Harris, Andrew Harris, Daisy Harrison, Clare Harrison, Thomas C. Hart, Louise Haskell, Sophia Hawkins, Ian Head, John Aaron Henry, Jennifer Hill, Susanne H.C. Hodgson, Mimi M. Hou, Elizabeth Howe, Nicola Howell, Cecilia Hutlin, Sabina Ikram, Catherine Isitt, Poppy Iveson, Susan Jackson, Frederic Jackson, Sir William James, Megan Jenkins, Elizabeth Jones, Kathryn Jones, Christine E. Jones, Bryony Jones, Reshma Kailath, Konstantinos Karampatsas, Jade Keen, Sarah Kelly, Dearbhla Kelly, David Kerr, Simon Kerridge, Liaquat Khan, Uzma Khan, Annabel Killen, Jasmin Kinch, Thomas B. King, Lloyd King, Jade King, Lucy Kingham-Page, Paul Klenerman, Francesca Knapper, Julian C. Knight, Daniel Knott, Stanislava Koleva, Alexandra Kupke, Colin W. Larkworthy, Jessica P.J. Larwood, Anna Laskey, Alison M. Lawrie, Arlene Lee, Kim Yee Ngan Lee, Emily A Lees, Helen Legge, Alice Lelliott, Nana-Marie Lemm, Amelia M. Lias, Aline Linder, Samuel Lipworth, Xinxue Liu, Shuchang Liu, Raquel Lopez Ramon, May Lwin, Francesca Mabesa, Meera Madhavan, Garry Mallett, Kushal Mansatta, Ines Marcal, Spyridoula Marinou, Emma Marlow, Julia L. Marshall, Jane Martin, Joanne McEwan, Lorna McInroy, Gretchen Meddaugh, Alexander J. Mentzer, Neginsadat Mirtorabi, Maria Moore, Edward Moran, Ella Morey, Victoria Morgan, Susan Jane Morris, Hazel Morrison, Gertraud Morshead, Richard Morter, Yama F. Mujadidi, Jilly Muller, Tatiana Munera-Huertas, Claire Munro, Alasdair Munro, Sarah Murphy, Vincent J. Munster, Philomena Mweu, Andrés Noé, Fay L. Nugent, Elizabeth Nuthall, Katie O'Brien, Daniel O'Connor, Blanché Oguti, Jennifer L. Oliver, Catarina Oliveira, Peter John O'Reilly, Mairead Osborn, Piper Osborne, Cathy Owen, Daniel Owens, Nelly Owino, Mihaela Pacurar, Kaye Parker, Helena Parracho, Maia Patrick-Smith, Victoria Payne, Jennifer Pearce, Yanchun Peng, Marco Polo Peralta Alvarez, James Perring, Katja Pfafferott, Dimitra Pipini, Emma Plested, Helen Pluess-Hall, Katrina Pollock, Ian Poulton, Laura Presland, Samuel Provstgaard-Morys, David Pulido, Kajal Radia, Fernando Ramos Lopez, Jade Rand, Helen Ratcliffe, Thomas Rawlinson, Sarah Rhead, Amy Riddell, Adam John Ritchie, Hannah Roberts, Joanna Robson, Sophie Roche, Cornelius Rohde, Christine S. Rollier, Rossana Romani, Indra Rudiansyah, Stephen Saich, Sara Sajjad, Stephannie Salvador, Lidia Sanchez Riera, Helen Sanders, Katherine Sanders, Shari Sapaun, Chloe Sayce, Ella Schofield, Gavin Screaton, Beatrice Selby, Calum Semple, Hannah R. Sharpe, Imam Shaik, Adam Shea, Holly Shelton, Sarah Silk, Laura Silva-Reyes, Donal T. Skelly, Heather Smee, Catherine C. Smith, David J. Smith, Rinn Song, Alexandra J. Spencer, Elizabeth Stafford, Amy Steele, Elena Stefanova, Lisa Stockdale, Anna Szigeti, Abdessamad Tahiri-Alaoui, Moira Tait, Helen Talbot, Rachel Tanner, Iona Jennifer Taylor, Victoria Taylor, Rebecca Te Water Naude, Nazia Thakur, Yrene Themistocleous, Andreas Themistocleous, Merin Thomas, Tonia M. Thomas, Amber Thompson, Samantha Thomson-Hill, Jennifer Tomlins, Susan Tonks, James Towner, Nguyen Tran, Julia A. Tree, Adam Truby, Kate Turkentine, Cheryl Turner, Nicola Turner, Sally Turner, Toby Tuthill, Marta Ulaszewska, Rachel Varughese, Neeltje Van Doremalen, Kristin Veighey, Marije K. Verheul, Iason Vichos, Elia Vitale, Laura Walker, Marion E.E. Watson, Benjamin Welham, Julie Wheat, Caroline White, Rachel White, Andrew T. Worth, Danny Wright, Suzie Wright, Xin Li Yao, Yasmine Yau, and Hodgson, S

Subjects
Male, T-Lymphocytes, Booster dose, 030204 cardiovascular system & hematology, Antibodies, Viral, law.invention, 0302 clinical medicine, Immunogenicity, Vaccine, Randomized controlled trial, law, Oxford COVID Vaccine Trial Group, Medicine, Single-Blind Method, 030212 general & internal medicine, 11 Medical and Health Sciences, Viral Vaccine, Immunogenicity, Covid19, General Medicine, Analgesics, Non-Narcotic, Vaccination, Spike Glycoprotein, Coronavirus, Female, Coronavirus Infections, Life Sciences & Biomedicine, Adult, medicine.medical_specialty, COVID-19 Vaccines, UNCOVER, Genetic Vectors, Pneumonia, Viral, Immunization, Secondary, Department of Error, Article, 03 medical and health sciences, Betacoronavirus, Medicine, General & Internal, Internal medicine, General & Internal Medicine, Humans, Adverse effect, Pandemics, Acetaminophen, Reactogenicity, Science & Technology, business.industry, SARS-CoV-2, COVID-19, Viral Vaccines, Antibodies, Neutralizing, United Kingdom, Clinical trial, Immunoglobulin G, Adenoviruses, Simian, business, ACUTE RESPIRATORY SYNDROME
Abstract

Background: The pandemic of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) might be curtailed by vaccination. We assessed the safety, reactogenicity, and immunogenicity of a viral vectored coronavirus vaccine that expresses the spike protein of SARS-CoV-2. Methods: We did a phase 1/2, single-blind, randomised controlled trial in five trial sites in the UK of a chimpanzee adenovirus-vectored vaccine (ChAdOx1 nCoV-19) expressing the SARS-CoV-2 spike protein compared with a meningococcal conjugate vaccine (MenACWY) as control. Healthy adults aged 18–55 years with no history of laboratory confirmed SARS-CoV-2 infection or of COVID-19-like symptoms were randomly assigned (1:1) to receive ChAdOx1 nCoV-19 at a dose of 5 × 10 10 viral particles or MenACWY as a single intramuscular injection. A protocol amendment in two of the five sites allowed prophylactic paracetamol to be administered before vaccination. Ten participants assigned to a non-randomised, unblinded ChAdOx1 nCoV-19 prime-boost group received a two-dose schedule, with the booster vaccine administered 28 days after the first dose. Humoral responses at baseline and following vaccination were assessed using a standardised total IgG ELISA against trimeric SARS-CoV-2 spike protein, a muliplexed immunoassay, three live SARS-CoV-2 neutralisation assays (a 50% plaque reduction neutralisation assay [PRNT 50]; a microneutralisation assay [MNA 50, MNA 80, and MNA 90]; and Marburg VN), and a pseudovirus neutralisation assay. Cellular responses were assessed using an ex-vivo interferon-γ enzyme-linked immunospot assay. The co-primary outcomes are to assess efficacy, as measured by cases of symptomatic virologically confirmed COVID-19, and safety, as measured by the occurrence of serious adverse events. Analyses were done by group allocation in participants who received the vaccine. Safety was assessed over 28 days after vaccination. Here, we report the preliminary findings on safety, reactogenicity, and cellular and humoral immune responses. The study is ongoing, and was registered at ISRCTN, 15281137, and ClinicalTrials.gov, NCT04324606. Findings: Between April 23 and May 21, 2020, 1077 participants were enrolled and assigned to receive either ChAdOx1 nCoV-19 (n=543) or MenACWY (n=534), ten of whom were enrolled in the non-randomised ChAdOx1 nCoV-19 prime-boost group. Local and systemic reactions were more common in the ChAdOx1 nCoV-19 group and many were reduced by use of prophylactic paracetamol, including pain, feeling feverish, chills, muscle ache, headache, and malaise (all p80 and in 35 (100%) participants when measured in PRNT 50. After a booster dose, all participants had neutralising activity (nine of nine in MNA 80 at day 42 and ten of ten in Marburg VN on day 56). Neutralising antibody responses correlated strongly with antibody levels measured by ELISA (R 2=0·67 by Marburg VN; p

Published
2020

9. Combining medical, physiotherapy and nursing undergraduates in high-fidelity simulation: determining students' perceptions

Author

Sabina Ikram, Josephine Seale, Lewis Whittingham, and Colin Butchers

Subjects
medicine.medical_specialty, 020205 medical informatics, media_common.quotation_subject, education, Specialty, Short Report, 030208 emergency & critical care medicine, Health Informatics, 02 engineering and technology, Interprofessional education, Education, 03 medical and health sciences, 0302 clinical medicine, Nursing, Modeling and Simulation, Perception, High fidelity simulation, 0202 electrical engineering, electronic engineering, information engineering, Physical therapy, medicine, Nursing specialties, Positive attitude, Psychology, media_common
Abstract

High-fidelity simulation (Hi-Fi SIM) is increasingly used to provide undergraduate interprofessional education (IPE). Although research has reported positive student feedback, studies have predominantly involved medical and nursing specialties. The present study sought to further explore this area by determining the perceptions of medical, physiotherapy and nursing students participating in the same simulation session. A total of 145 medical, physiotherapy and nursing undergraduate students jointly participated in a novel Hi-Fi SIM IPE programme. Immediately before and after their session, students completed the KidSIM ATTITUDES questionnaire where statements were rated regarding simulation, IPE and human factors. A high score indicated a more positive attitude. Physiotherapy students reported the lowest level of previous Hi-Fi SIM experience. Students from each specialty had more positive attitudes related to simulation, IPE and human factors following their simulation. Physiotherapy students had predominantly less positive attitudes compared with nursing and medical students. Participation in an IPE Hi-Fi SIM session positively impacted on the perceptions of medical, physiotherapy and nursing students regarding the relevance of simulation, IPE and the importance of human factors. Such findings support the use of this learning modality for the provision of IPE in a range of specialties.

Published
2017

10. P57 The role of high-fidelity simulation in inter-professional education involving medical, nursing and physiotherapy undergraduate students

Author

Josephine Seale, Lewis Whittingham, and Sabina Ikram

Subjects
medicine.medical_specialty, business.industry, Professional development, Specialty, 030208 emergency & critical care medicine, Session (web analytics), Likert scale, 03 medical and health sciences, 0302 clinical medicine, Nursing, Health care, High fidelity simulation, Physical therapy, medicine, 030212 general & internal medicine, Nurse education, business, Psychology, Curriculum
Abstract

Introduction High-Fidelity Simulation (HFS) involving a mix of healthcare students provides a controlled environment for the development of technical and non-technical clinical skills in conjunction with a greater understanding of the roles of different professions. Research involving HFS with undergraduate medical and nursing students has previously shown to effectively deliver inter-professional education (IPE) to these groups.1 However, little research has focused upon the additional involvement of undergraduate physiotherapy students. The present study sought to compare the simulation based perceptions of physiotherapy, medical and nursing students before and after a HFS inter-professional session. Methods A total of 145 undergraduate students (26 physiotherapy, 54 medical, 65 nursing) participated in a HFS session involving a minimum of three students from at least two specialties. Each ten minute simulation involved the management of an acutely unwell patient. Immediately before and after their session students completed the previously validated Kid-SIM ATTITUDES questionnaire2 consisting of a five point Likert scale to rate statements related to five general domains: Relevance of simulation; Opportunities for IPE; Communication; Roles and responsibilities; Situation awareness. A mixed 2-way ANOVA compared pre and post questionnaire responses by the three student groups. Data was collected regarding students’ previous IPE and simulation experiences. Results Physiotherapy students reported the lowest level of previous simulation experience compared to medical and nursing students. For each domain there was a significant difference in pre and post questionnaire responses regardless of the specialty, specifically students more strongly agreed with the statements following their simulation experience (each domain; p Discussion Participation in HFS improves the perceptions of physiotherapy, medical and nursing students with regard to the relevance of this teaching modality and the importance of non-technical skills. The lower perceptions of physiotherapy students compared to other specialties is likely, in part, to reflect the presence of fewer simulation opportunities for these students in their current training. Such findings demonstrate the ability of inter-professional HFS to positively impact on the views of students from a range of disciplines and supports the integration of such training into their individual curriculums, a situation which is currently lacking with regard to physiotherapy. References . Jakobson RB, Gran SF, Grimsmo B, Arntzen K, Fosse E, Hiortdahl P. Examining participant perceptions of an interprofessional simulation-based trauma team training for medical and nursing students. Journal of Interprofessional Care 2017; 1-9. Available from: http://www.tandfonline.com/doi/abs/10.1080/13561820.2017.1376625?journalCode=ijic20 [Accessed 10/10/2017]. . Lockeman KS, Appelbaum NP, Dow AW, Orr S, Huff TA, Hogan CJ et al. The effect of an interprofessional simulation-based education program on perceptions and stereotypes of nursing and medical students: A quasi-experimental study. Nurse Education Today 2017; 58:32-37. Available from: http://www.sciencedirect.com/science/article/pii/S0260691717301740?via%3Dihub [Accessed 10/10/2017]. . Sigalet E, Donnon T, Grant V. Undergraduate students9 perceptions of and attitudes toward a simulation-based interprofessional curriculum: the KidSIM ATTITUDES questionnaire. Simulation in Healthcare 2012;7(6):353–8

Published
2017

11. 10–15 High-fidelity simulation in inter-professional education with medical, nursing and physiotherapy undergraduate students

Author

Josephine Seale, Lewis Whittingham, and Sabina Ikram

Subjects
Teamwork, medicine.medical_specialty, Physiotherapy education, business.industry, media_common.quotation_subject, education, Significant difference, Professional development, Session (web analytics), Likert scale, Nursing, Health care, High fidelity simulation, Physical therapy, medicine, business, media_common
Abstract

Introduction High-fidelity simulation (HFS) is frequently used to develop the clinical and communication skills of undergraduate medical students. With the increasing emphasis on multi-disciplinary teamwork in healthcare, HFS has been identified as an ideal means by which students from different specialities can practise working together. Previous studies have demonstrated the educational benefits of combining medical and nursing students. However, despite evidence indicating a positive role for HFS in undergraduate physiotherapy education, limited research has evaluated simulation combining medical, nursing and physiotherapy students. Methods 145 undergraduate students (26 physiotherapy, 54 medical, 65 nursing) at King’s College London participated in a HFS inter-professional (IPE) programme. Each session involved students from at least two specialties undertaking a simulated clinical scenario whilst being observed by their peers via video link. To assess student perceptions, students completed the previously validated KidSIM ATTITUDES questionnaire before and after their session. A 5-point Likert scale was used to rate 30 statements related to five domains. Results were analysed using a mixed 2-way ANOVA. Results Physiotherapy students reported less prior simulation experience (11.5%) compared to medical (32.1%) and nursing (48.4%) students. There was a significant difference in pre and post questionnaire responses for each speciality with students more strongly agreeing with statements following simulation (each domain; p Conclusion Following participation in HFS, undergraduates from all three disciplines reported more positive perceptions regarding the role of simulation as a teaching modality. The less positive views expressed by physiotherapy students may partly reflect their reduced prior exposure to simulation. The results of this study highlight HFS as a valuable means of delivering IPE and support an increased exposure to simulation for all three specialities especially physiotherapy students.

Published
2017

12. Global health short course

Author

Sabina Ikram

Subjects
medicine.medical_specialty, Medical education, Work abroad, Public health, education, Global health, medicine, Short course, General Medicine, Sociology
Abstract

The global health short course held at Imperial College London has been running once a year for the past few years. It takes place over five days and offers an introduction to global health, covering a wide range of related topics. The course directors are Alan Fenwick, professor of tropical parasitology at the college, and Helen Ward, director of education at the college’s School of Public Health. The course is for anyone with an interest or career aspirations in the field of global health. Participants on this year’s course came from across the world and from a variety of backgrounds—for example, medical students, doctors, a nursing student, a midwife, and nutritionists. I did the course during the second year of my foundation training, but the course would be suitable for students and doctors at any stage of training. I hope to pursue a career in infectious diseases medicine and would like to work abroad at some point to gain further experience …

Published
2012

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