Neutralizing antibody correlate of protection against severe-critical COVID-19 in the ENSEMBLE single-dose Ad26.COV2.S vaccine efficacy trial

Autor: Lindsay N. Carpp, Ollivier Hyrien, Youyi Fong, David Benkeser, Sanne Roels, Daniel J. Stieh, Ilse Van Dromme, Griet A. Van Roey, Avi Kenny, Ying Huang, Marco Carone, Adrian B. McDermott, Christopher R. Houchens, Karen Martins, Lakshmi Jayashankar, Flora Castellino, Obrimpong Amoa-Awua, Manjula Basappa, Britta Flach, Bob C. Lin, Christopher Moore, Mursal Naisan, Muhammed Naqvi, Sandeep Narpala, Sarah O’Connell, Allen Mueller, Leo Serebryannyy, Mike Castro, Jennifer Wang, Christos J. Petropoulos, Alex Luedtke, Yiwen Lu, Chenchen Yu, Michal Juraska, Nima S. Hejazi, Daniel N. Wolfe, Jerald Sadoff, Glenda E. Gray, Beatriz Grinsztejn, Paul A. Goepfert, Linda-Gail Bekker, Aditya H. Gaur, Valdilea G. Veloso, April K. Randhawa, Michele P. Andrasik, Jenny Hendriks, Carla Truyers, An Vandebosch, Frank Struyf, Hanneke Schuitemaker, Macaya Douoguih, James G. Kublin, Lawrence Corey, Kathleen M. Neuzil, Dean Follmann, Richard A. Koup, Ruben O. Donis, Peter B. Gilbert, On behalf of the Immune Assays Team, the Coronavirus Vaccine Prevention Network (CoVPN)/ENSEMBLE Team, the United States Government (USG)/CoVPN Biostatistics Team

Publikováno v: Nature Communications, Vol 15, Iss 1, Pp 1-18 (2024)

Abstract Assessment of immune correlates of severe COVID-19 has been hampered by the low numbers of severe cases in COVID-19 vaccine efficacy (VE) trials. We assess neutralizing and binding antibody levels at 4 weeks post-Ad26.COV2.S vaccination as c

Externí odkaz: https://doaj.org/article/e3fbd928bb5b421b95c9d27047187105

Immune correlates analysis of the Imbokodo (HVTN 705/HPX2008) efficacy trial of a mosaic HIV-1 vaccine regimen evaluated in Southern African people assigned female sex at birth: a two-phase case-control studyResearch in context

Autor: Avi Kenny, Janine van Duijn, One Dintwe, Jack Heptinstall, Randy Burnham, Sheetal Sawant, Lu Zhang, Dieter Mielke, Sharon Khuzwayo, Faatima Laher Omar, Sherry Stanfield-Oakley, Taylor Keyes, Brooke Dunn, Derrick Goodman, Youyi Fong, David Benkeser, Rodger Zou, John Hural, Ollivier Hyrien, Michal Juraska, Alex Luedtke, Lars van der Laan, Elena E. Giorgi, Craig Magaret, Lindsay N. Carpp, Laura Pattacini, Tom van de Kerkhof, Bette Korber, Wouter Willems, Leigh H. Fisher, Hanneke Schuitemaker, Edith Swann, James G. Kublin, Maria G. Pau, Susan Buchbinder, Frank Tomaka, Steven Nijs, Ludo Lavreys, Huub C. Gelderblom, Lawrence Corey, Kathryn Mngadi, Glenda E. Gray, Erica Borducchi, Jenny Hendriks, Kelly E. Seaton, Susan Zolla-Pazner, Dan H. Barouch, Guido Ferrari, Stephen C. De Rosa, M Juliana McElrath, Erica Andersen-Nissen, Daniel J. Stieh, Georgia D. Tomaras, Peter B. Gilbert, Jon Allagappen, Jessica Andriesen, Alison Ayres, Saman Baral, Linda-Gail Bekker, Asiphe Besethi, Caroline Borremans, Esmee Braams, Caroline Brackett, William Brumskine, Roma Chilengi, Rachel Choi, Thozama Dubula, Jaiden Seongmi Dumas, Radhika Etikala, Zelda Euler, Sarah Everett, Nigel Garrett, Huub Gelderblom, Katherine Gill, Kevin Gillespie, Dimitri Goedhart, Erik Goosmann, Shannon Grant, Ellie Hands, Barton Haynes, Bronwill Herringer, Zaheer Hoosain, Mina Hosseinipour, Portia Hunidzarira, Julia Hutter, Mubiana Inambao, Craig Innes, William Kilembe, Philippus Kotze, Sheena Kotze, Fatima Laher, Imre Laszlo, Erica Lazarus, Hua-Xin Liao, Yong Lin, Helen Lu, Judith Lucas, Mookho Malahleha, Tara McNair, Peter Meerts, Zinhle Mgaga, Mahlodi Montlha, Boitumelo Mosito, Andrew Moultrie, Sarah Mudrak, Valérie Oriol-Mathieu, Marcella Sarzotti-Kelsoe, Matson Tso Mathebula, Mitch Matoga, Rachael McClennen, Pamela Mda, Vimla Naicker, Logashvari Naidoo, Cindy-Ann Okkers, Saleha Omarjee, Hella Pasmans, Tricia Philip, Abraham Pinter, Annah Pitsi, Ornelia Ramos, April Randhawa, Sanne Roels, Shamiska Rohith, Lucy Rutten, Jerald Sadoff, Gabriela Salinas, Yvonne Salzgeber, Lorenz Scheppler, Katharine Schwedhelm, Nicolette Schuller, Angelina Sharak, Carrie Sopher, Terence Tafatatha, Simbarashe G. Takuva, Chan Tang, An Vandebosch, Edna Viegas, Valentin Voillet, Frank Wegmann, Mo Weijtens, Stephany Wilcox, Anthony Williams, Chenchen Yu, Pei-Chun Yu, Olive Yuan, Xuehan Zhang

Publikováno v: EBioMedicine, Vol 108, Iss , Pp 105320- (2024)

Summary: Background: The HVTN 705 Imbokodo trial of 2636 people without HIV and assigned female sex at birth, conducted in southern Africa, evaluated a heterologous HIV-1 vaccine regimen: mosaic adenovirus 26-based vaccine (Ad26.Mos4.HIV) at Months 0

Externí odkaz: https://doaj.org/article/f41b2bdf77344ddab5c165f46025f8a4

Pharmacokinetic serum concentrations of VRC01 correlate with prevention of HIV-1 acquisitionResearch in context

Autor: Kelly E. Seaton, Yunda Huang, Shelly Karuna, Jack R. Heptinstall, Caroline Brackett, Kelvin Chiong, Lily Zhang, Nicole L. Yates, Mark Sampson, Erika Rudnicki, Michal Juraska, Allan C. deCamp, Paul T. Edlefsen, James I. Mullins, Carolyn Williamson, Raabya Rossenkhan, Elena E. Giorgi, Avi Kenny, Heather Angier, April Randhawa, Joshua A. Weiner, Michelle Rojas, Marcella Sarzotti-Kelsoe, Lu Zhang, Sheetal Sawant, Margaret E. Ackerman, Adrian B. McDermott, John R. Mascola, John Hural, M. Julianna McElrath, Philip Andrew, Jose A. Hidalgo, Jesse Clark, Fatima Laher, Catherine Orrell, Ian Frank, Pedro Gonzales, Srilatha Edupuganti, Nyaradzo Mgodi, Lawrence Corey, Lynn Morris, David Montefiori, Myron S. Cohen, Peter B. Gilbert, Georgia D. Tomaras

Publikováno v: EBioMedicine, Vol 93, Iss , Pp 104590- (2023)

Summary: Background: The phase 2b proof-of-concept Antibody Mediated Prevention (AMP) trials showed that VRC01, an anti-HIV-1 broadly neutralising antibody (bnAb), prevented acquisition of HIV-1 sensitive to VRC01. To inform future study design and d

Externí odkaz: https://doaj.org/article/1fb6811de76c4d6b9e00985ef3384be8

Design and implementation of a mobile health electronic data capture platform that functions in fully-disconnected settings: a pilot study in rural Liberia

Autor: Avi Kenny, Nicholas Gordon, Jordan Downey, Owen Eddins, Kathleen Buchholz, Alvin Menyon, William Mansah

Publikováno v: BMC Medical Informatics and Decision Making, Vol 20, Iss 1, Pp 1-8 (2020)

Abstract Background Mobile phones and personal digital assistants have been used for data collection in developing world settings for over three decades, and have become increasingly common. However, the use of electronic data capture (EDC) through m

Externí odkaz: https://doaj.org/article/c74a5b22271248a999bc7cddac983ced

Model misspecification in stepped wedge trials: Random effects for time or treatment

Autor: Avi Kenny, Emily Voldal, Patrick J. Heagerty, Fan Xia, James Hughes

Publikováno v: Stat Med

Mixed models are commonly used to analyze stepped wedge trials (SWTs) to account for clustering and repeated measures on clusters. One critical issue researchers face is whether to include a random time effect or a random treatment effect. When the w

Externí odkaz: https://explore.openaire.eu/search/publication?articleId=doi_dedup___::1efc7859f2a74b408c5b3d2cb1409e16
https://doi.org/10.1002/sim.9326