Prepared to Act: Lessons Learned by the Special Pathogens Research Network, Based on Collaborations with the NIAID-Led Adaptive COVID-19 Treatment Trial
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Emergency+Management">Emergency Management</a>
The need for well-controlled clinical trials is fundamental to advancing medicine. Care should be taken to maintain high standards in trial design and conduct even during emergency medical events such as an infectious disease outbreak. In 2020, SARS-CoV-2 emerged and rapidly impacted populations around the globe.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Corri+B+Levine%2C%C2%A0Sami+Vasistha%2C%C2%A0Caroline+Croyle+Persson%2C%C2%A0LuAnn+R+Larson%2C%C2%A0Christopher+J+Kratochvil%2C%C2%A0Aneesh+K+Mehta%2C%C2%A0Lindsay+J+Hicks%2C%C2%A0Abigail+E+Lowe%2C%C2%A0Mark+G+Kortepeter%2C%C2%A0Lauren+M+Sauer">Corri B Levine, Sami Vasistha, Caroline Croyle Persson, LuAnn R Larson, Christopher J Kratochvil, Aneesh K Mehta, Lindsay J Hicks, Abigail E Lowe, Mark G Kortepeter, Lauren M Sauer</a>
2022-05-31
2024-03-28 by J. Mundy – not yet reviewed asset – bumping first review 1 year
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
2024-07-20
Safety, tolerability, and immunogenicity of an inactivated SARS-CoV-2 vaccine in healthy adults aged 18–59 years: a randomised, double-blind, placebo-controlled, phase 1/2 clinical trial
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Laboratory">Laboratory</a>
With the unprecedented morbidity and mortality associated with the COVID-19 pandemic, a vaccine against COVID-19 is urgently needed. We investigated CoronaVac (Sinovac Life Sciences, Beijing, China), an inactivated vaccine candidate against COVID-19, containing inactivated severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), for its safety, tolerability and immunogenicity.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Zhang%2C+Yanjun%2C+Gang+Zeng%2C+Hongxing+Pan%2C+Changgui+Li%2C+Yaling+Hu%2C+Kai+Chu%2C+Weixiao+Han%2C+Zhen+Chen%2C+Rong+Tang%2C+Weidong+Yin%2C+Xin+Chen%2C+Yuansheng+Hu%2C+Xiaoyong+Liu%2C+Congbing+Jiang%2C+Jingxin+Li%2C+Minnan+Yang%2C+Yan+Song%2C+Xiangxi+Wang%2C+Qiang+Gao%2C+and+Fengcai+Zhu.+">Zhang, Yanjun, Gang Zeng, Hongxing Pan, Changgui Li, Yaling Hu, Kai Chu, Weixiao Han, Zhen Chen, Rong Tang, Weidong Yin, Xin Chen, Yuansheng Hu, Xiaoyong Liu, Congbing Jiang, Jingxin Li, Minnan Yang, Yan Song, Xiangxi Wang, Qiang Gao, and Fengcai Zhu. </a>
2020-11-17
2023-12-18 skipped for review by Lab, bump to next round
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
Laboratory
2024-04-01
Safety, tolerability, pharmacokinetics, and immunogenicity of a human monoclonal antibody targeting the G glycoprotein of henipaviruses in healthy adults: a first-in-human, randomised, controlled, phase 1 study
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Laboratory">Laboratory</a>
The monoclonal antibody m102.4 is a potent, fully human antibody that neutralises Hendra and Nipah viruses in vitro and in vivo. We aimed to investigate the safety, tolerability, pharmacokinetics, and immunogenicity of m102.4 in healthy adults.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Playford%2C+E.+G.%2C+T.+Munro%2C+S.+M.+Mahler%2C+S.+Elliott%2C+M.+Gerometta%2C+K.+L.+Hoger%2C+M.+L.+Jones%2C+P.+Griffin%2C+K.+D.+Lynch%2C+H.+Carroll%2C+D.+El+Saadi%2C+M.+E.+Gilmour%2C+B.+Hughes%2C+K.+Hughes%2C+E.+Huang%2C+C.+de+Bakker%2C+R.+Klein%2C+M.+G.+Scher%2C+I.+L.+Smith%2C+L.+F.+Wang%2C+S.+B.+Lambert%2C+D.+S.+Dimitrov%2C+P.+P.+Gray%2C+and+C.+C.+Broder.">Playford, E. G., T. Munro, S. M. Mahler, S. Elliott, M. Gerometta, K. L. Hoger, M. L. Jones, P. Griffin, K. D. Lynch, H. Carroll, D. El Saadi, M. E. Gilmour, B. Hughes, K. Hughes, E. Huang, C. de Bakker, R. Klein, M. G. Scher, I. L. Smith, L. F. Wang, S. B. Lambert, D. S. Dimitrov, P. P. Gray, and C. C. Broder.</a>
2020-04
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
2024-02-09
Dexamethasone in Hospitalized Patients with Covid-19 — Preliminary Report
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
Coronavirus disease 2019 (Covid-19) is associated with diffuse lung damage. Glucocorticoids may modulate inflammation-mediated lung injury and thereby reduce progression to respiratory failure and death.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=The+RECOVERY+Collaborative+Group.+">The RECOVERY Collaborative Group. </a>
2020-07-17
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
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
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
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.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Oxford+COVID+Vaccine+Trial+Group">Oxford COVID Vaccine Trial Group</a>
Folegatti, Pedro M., 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, 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, 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, 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, Stanislava Koleva, Alexandra Kupke, Colin W. Larkworthy, Jessica P. J. Larwood, Anna Laskey, Alison M. Lawrie, Arlene Lee, Kim Yee Ngan Lee, Emily A. Lee, 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, Gary Mallett, Kushal Mansatta, Inēs Marcal, Spyridoula Marinou, Emma Marlow, Julia L. Marshall, Jane Martin, Joanne McEwan, 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. Muster, Philomena Mweu, Andrés Noé, Fay L. Nugent, Elizabeth Nugent, 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, Rosanna 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, 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, and Yasmine Yau.
2020-07-20
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
Immunogenicity and safety of a recombinant adenovirus type-5-vectored COVID-19 vaccine in healthy adults aged 18 years or older: a randomised, double-blind, placebo-controlled, phase 2 trial
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
This is the first randomised controlled trial for assessment of the immunogenicity and safety of a candidate non-replicating adenovirus type-5 (Ad5)-vectored COVID-19 vaccine, aiming to determine an appropriate dose of the candidate vaccine for an efficacy study.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Zhu%2C+Feng-Cai%2C+Xu-Hua+Guan%2C+Yu-Hua+Li%2C+Jian-Ying+Huang%2C+Tao+Jiang%2C+Li-Hua+Hou%2C+Jing-Xin+Li%2C+Bei-Fang+Yang%2C+Ling+Wang%2C+Wen-Juan+Wang%2C+Shi-Po+Wu%2C+Zhao+Wang%2C+Xiao-Hong+Wu%2C+Jun-Jie+Xu%2C+Zhe+Zhang%2C+Si-Yue+Jia%2C+Bu-Sen+Wang%2C+Yi+Hu%2C+Jing-Jing+Liu%2C+Jun+Zhang%2C+Xiao-Ai+Qian%2C+Qiong+Li%2C+Hong-Xing+Pan%2C+Hu-Dachuan+Jiang%2C+Peng+Deng%2C+Jin-Bo+Gou%2C+Xue-Wen+Wang%2C+Xing-Huan+Wang%2C+and+Wei+Chen.+">Zhu, Feng-Cai, Xu-Hua Guan, Yu-Hua Li, Jian-Ying Huang, Tao Jiang, Li-Hua Hou, Jing-Xin Li, Bei-Fang Yang, Ling Wang, Wen-Juan Wang, Shi-Po Wu, Zhao Wang, Xiao-Hong Wu, Jun-Jie Xu, Zhe Zhang, Si-Yue Jia, Bu-Sen Wang, Yi Hu, Jing-Jing Liu, Jun Zhang, Xiao-Ai Qian, Qiong Li, Hong-Xing Pan, Hu-Dachuan Jiang, Peng Deng, Jin-Bo Gou, Xue-Wen Wang, Xing-Huan Wang, and Wei Chen. </a>
2020-07-20
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
A Randomized Trial of Hydroxychloroquine as Postexposure Prophylaxis for Covid-19
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
This reports on a randomized, double-blind, placebo-controlled trial across the United States and parts of Canada testing hydroxychloroquine as postexposure prophylaxis.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Boulware%2C+David+R.%2C+Matthew+F.+Pullen%2C+Ananta+S.+Bangdiwala%2C+Katelyn+A.+Pastick%2C+Sarah+M.+Lofgren%2C+Elizabeth+C.+Okafor%2C+Caleb+P.+Skipper%2C+Alanna+A.+Nascene%2C+Melanie+R.+Nicol%2C+Mahsa+Abassi%2C+Nicole+W.+Engen%2C+Matthew+P.+Cheng%2C+Derek+LaBar%2C+Sylvain+A.+Lother%2C+Lauren+J.+MacKenzie%2C+Glen+Drobot%2C+Nicole+Marten%2C+Ryan+Zarychanski%2C+Lauren+E.+Kelly%2C+Ilan+S.+Schwartz%2C+Emily+G.+McDonald%2C+Radha+Rajasingham%2C+Todd+C.+Lee%2C+and+Kathy+H.+Hullsiek.+">Boulware, David R., Matthew F. Pullen, Ananta S. Bangdiwala, Katelyn A. Pastick, Sarah M. Lofgren, Elizabeth C. Okafor, Caleb P. Skipper, Alanna A. Nascene, Melanie R. Nicol, Mahsa Abassi, Nicole W. Engen, Matthew P. Cheng, Derek LaBar, Sylvain A. Lother, Lauren J. MacKenzie, Glen Drobot, Nicole Marten, Ryan Zarychanski, Lauren E. Kelly, Ilan S. Schwartz, Emily G. McDonald, Radha Rajasingham, Todd C. Lee, and Kathy H. Hullsiek. </a>
2020-08-06
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
Single-dose administration and the influence of the timing of the booster dose on immunogenicity and efficacy of ChAdOx1 nCoV-19 (AZD1222) vaccine: a pooled analysis of four randomised trials
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
The ChAdOx1 nCoV-19 (AZD1222) vaccine has been approved for emergency use by the UK regulatory authority, Medicines and Healthcare products Regulatory Agency, with a regimen of two standard doses given with an interval of 4–12 weeks.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=the+Oxford+COVID+Vaccine+Trial+Group">the Oxford COVID Vaccine Trial Group</a>
Voysey, Merryn, 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, Elizabeth A. Clutterbuck, Andrea M. Collins, Clare L. Cutland, Thomas C. Darton, Keertan Dheda, Christina Dold, Christopher J. A. Duncan, Katherine R. W. Emary, Katie J. Ewer, Amy Flaxman, Lee Fairlie, Saul N. Faust, Shuo Feng, Daniela M. Ferreira, Adam Finn, Eva Galiza, Anna L. Goodman, Catherine M. Green, Christopher A. Green, Melanie Greenland, Catherine Hill, Helen C. Hill, Ian Hirsch, Alane Izu, Daniel Jenkin, Carina C. D. Joe, Simon Kerridge, Anthonet Koen, Gaurav Kwatra, Rajeka Lazarus, Vincenzo Libri, Patrick J. Lillie, Natalie G. Marchevsky, Richard P. Marshall, Ana V. A. Mendes, Eveline P. Milan, Angela M. Minassian, Alastair McGregor, Yama F. Mujadidi, Anusha Nana, Sherman D. Padayachee, Daniel J. Phillips, Ana Pittella, Emma Plested, Katrina M. Pollock, Maheshi N. Ramasamy, Adam J. Ritchie, Hannah Robinson, Alexandre V. Schwarzbold, Andrew Smith, Rinn Song, Matthew D. Snape, Eduardo Sprinz, Rebecca K. Sutherland, Emma C. Thomson, M. Estée Török, Mark Toshner, David P. J. Turner, Johan Vekemans, Tonya L. Villafana, Thomas White, Christopher J. Williams, Alexander D. Douglas, Adrian V. S. Hill, Teresa Lambe, Sarah C. Gilbert, and Andrew J. Pollard.
2021-02-19
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
Safety and immunogenicity of an inactivated SARS-CoV-2 vaccine, BBV152: interim results from a double-blind, randomised, multicentre, phase 2 trial, and 3-month follow-up of a double-blind, randomised phase 1 trial
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
BBV152 is a whole-virion inactivated SARS-CoV-2 vaccine (3 μg or 6 μg) formulated with a toll-like receptor 7/8 agonist molecule (IMDG) adsorbed to alum (Algel). We previously reported findings from a double-blind, multicentre, randomised, controlled phase 1 trial on the safety and immunogenicity of three different formulations of BBV152 (3 μg with Algel-IMDG, 6 μg with Algel-IMDG, or 6 μg with Algel) and one Algel-only control (no antigen), with the first dose administered on day 0 and the second dose on day 14.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Ella%2C+Raches%2C+Siddharth+Reddy%2C+Harsh+Jogdand%2C+Vamshi+Sarangi%2C+Brunda+Ganneru%2C+Sai+Prasad%2C+Dipankar+Das%2C+Dugyala+Raju%2C+Usha+Praturi%2C+Gajanan+Sapkal%2C+Pragya+Yadav%2C+Prabhakar+Reddy%2C+Savita+Verma%2C+Chandramani+Singh%2C+Sagar+Vivek+Redkar%2C+Chandra+Sekhar+Gillurkar%2C+Jitendra+Singh+Kushwaha%2C+Satyajit+Mohapatra%2C+Amit+Bhate%2C+Sanjay+Rai%2C+Samiran+Panda%2C+Priya+Abraham%2C+Nivedita+Gupta%2C+Krishna+Ella%2C+Balram+Bhargava%2C+and+Krishna+Mohan+Vadrevu.+">Ella, Raches, Siddharth Reddy, Harsh Jogdand, Vamshi Sarangi, Brunda Ganneru, Sai Prasad, Dipankar Das, Dugyala Raju, Usha Praturi, Gajanan Sapkal, Pragya Yadav, Prabhakar Reddy, Savita Verma, Chandramani Singh, Sagar Vivek Redkar, Chandra Sekhar Gillurkar, Jitendra Singh Kushwaha, Satyajit Mohapatra, Amit Bhate, Sanjay Rai, Samiran Panda, Priya Abraham, Nivedita Gupta, Krishna Ella, Balram Bhargava, and Krishna Mohan Vadrevu. </a>
2021-03-08
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
Safety and immunogenicity of an MF59-adjuvanted spike glycoprotein-clamp vaccine for SARS-CoV-2: a randomised, double-blind, placebo-controlled, phase 1 trial
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Research">Research</a>
Given the scale of the ongoing COVID-19 pandemic, the development of vaccines based on different platforms is essential, particularly in light of emerging viral variants, the absence of information on vaccine-induced immune durability, and potential paediatric use. We aimed to assess the safety and immunogenicity of an MF59-adjuvanted subunit vaccine for COVID-19 based on recombinant SARS-CoV-2 spike glycoprotein stabilised in a pre-fusion conformation by a novel molecular clamp (spike glycoprotein-clamp [sclamp]).
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Chappell%2C+Keith+J.%2C+Francesca+L.+Mordant%2C+Zheyi+Li%2C+Danushka+K.+Wijesundara%2C+Paula+Ellenberg%2C+Julia+A.+Lackenby%2C+Stacey+T.+M.+Cheung%2C+Naphak+Modhiran%2C+Michael+S.+Avumegah%2C+Christina+L.+Henderson%2C+Kym+Hoger%2C+Paul+Griffin%2C+Jillian+Bennet%2C+Luca+Hensen%2C+Wuji+Zhang%2C+Thi+H.+O.+Nguyen%2C+Sara+Marrero-Hernandez%2C+Kevin+J.+Selva%2C+Amy+W.+Chung%2C+Mai+H.+Tran%2C+Peter+Tapley%2C+James+Barnes%2C+Patrick+C.+Reading%2C+Suellen+Nicholson%2C+Stavroula+Corby%2C+Thomas+Holgate%2C+Bruce+D.+Wines%2C+P.+Mark+Hogarth%2C+Katherine+Kedzierska%2C+Damian+F.+J.+Purcell%2C+Charani+Ranasinghe%2C+Kanta+Subbarao%2C+Daniel+Watterson%2C+Paul+R.+Young%2C+and+Trent+P.+Munro.">Chappell, Keith J., Francesca L. Mordant, Zheyi Li, Danushka K. Wijesundara, Paula Ellenberg, Julia A. Lackenby, Stacey T. M. Cheung, Naphak Modhiran, Michael S. Avumegah, Christina L. Henderson, Kym Hoger, Paul Griffin, Jillian Bennet, Luca Hensen, Wuji Zhang, Thi H. O. Nguyen, Sara Marrero-Hernandez, Kevin J. Selva, Amy W. Chung, Mai H. Tran, Peter Tapley, James Barnes, Patrick C. Reading, Suellen Nicholson, Stavroula Corby, Thomas Holgate, Bruce D. Wines, P. Mark Hogarth, Katherine Kedzierska, Damian F. J. Purcell, Charani Ranasinghe, Kanta Subbarao, Daniel Watterson, Paul R. Young, and Trent P. Munro.</a>
2021-04-19
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
The RECOVERY Platform
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Treatment+%26+Care">Treatment & Care</a>
In a platform trial, patients with a single disease are randomly assigned to a group of different therapies on the basis of a decision algorithm to determine whether any therapy has benefit.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Normand%2C+Sharon-Lise+T.+">Normand, Sharon-Lise T. </a>
2020-07-21
2022-09-27 - general asset review - Treatment & Care group
2024-03-28 by J. Mundy – Treatment & Care group review 2023 (Q2) skipped – bumping to 2024 (Q2)
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
Adult Care
2024-11-27
Baricitinib versus dexamethasone for adults hospitalised with COVID-19 (ACTT-4): a randomised, double-blind, double placebo-controlled trial
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=49&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Treatment+%26+Care">Treatment & Care</a>
Baricitinib and dexamethasone have randomised trials supporting their use for the treatment of patients with COVID-19. We assessed the combination of baricitinib plus remdesivir versus dexamethasone plus remdesivir in preventing progression to mechanical ventilation or death in hospitalised patients with COVID-19.
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=39&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=ACTT-+Study+Group">ACTT- Study Group</a>
Cameron R Wolfe, Kay M Tomashek, Thomas F Patterson, Carlos A Gomez, Vincent C Marconi, Mamta K Jain, Otto O Yang, Catharine I Paules, Guillermo M Ruiz Palacios, Robert Grossberg, Michelle S Harkins, Richard A Mularski, Nathaniel Erdmann, Uriel Sandkovsky, Eyad Almasri, Justino Regalado Pineda, Alexandra W Dretler, Diego Lopez de Castilla, Angela R Branche, Pauline K Park, Aneesh K Mehta, William R Short, Susan L F McLellan, Susan Kline, Nicole M Iovine, Hana M El Sahly, Sarah B Doernberg, Myoung-Don Oh, Nikhil Huprikar, Elizabeth Hohmann, Colleen F Kelley, Mark Holodniy, Eu Suk Kim, Daniel A Sweeney, Robert W Finberg, Kevin A Grimes, Ryan C Maves, Emily R Ko, John J Engemann, Barbara S Taylor, Philip O Ponce, LuAnn Larson, Dante Paolo Melendez, Allan M Seibert, Nadine G Rouphael, Joslyn Strebe, Jesse L Clark, Kathleen G Julian, Alfredo Ponce de Leon, Anabela Cardoso, Stephanie de Bono, Robert L Atmar, Anuradha Ganesan, Jennifer L Ferreira, Michelle Green, Mat Makowski, Tyler Bonnett, Tatiana Beresnev, Varduhi Ghazaryan, Walla Dempsey, Seema U Nayak, Lori E Dodd, John H Beigel, Andre C Kalil
2022-05-23
2024-03-28 by J. Mundy – not yet reviewed asset – bumping first review 1 year
<a href="/items/browse?advanced%5B0%5D%5Belement_id%5D=51&advanced%5B0%5D%5Btype%5D=is+exactly&advanced%5B0%5D%5Bterms%5D=Publication">Publication</a>
2024-07-20