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

Adjusting for time-varying treatment switches in randomized clinical trials: the danger of extrapolation and how to avoid it

Autor: Michiels, Hege, Vandebosch, An, Vansteelandt, Stijn

When choosing estimands and estimators in randomized clinical trials, caution is warranted as intercurrent events, such as - due to patients who switch treatment after disease progression, are often extreme. Statistical analyses may then easily lure

Externí odkaz: http://arxiv.org/abs/2303.06099

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

Quantifying how single dose Ad26.COV2.S vaccine efficacy depends on Spike sequence features

Autor: Craig A. Magaret, Li Li, Allan C. deCamp, Morgane Rolland, Michal Juraska, Brian D. Williamson, James Ludwig, Cindy Molitor, David Benkeser, Alex Luedtke, Brian Simpkins, Fei Heng, Yanqing Sun, Lindsay N. Carpp, Hongjun Bai, Bethany L. Dearlove, Elena E. Giorgi, Mandy Jongeneelen, Boerries Brandenburg, Matthew McCallum, John E. Bowen, David Veesler, Jerald Sadoff, Glenda E. Gray, Sanne Roels, An Vandebosch, Daniel J. Stieh, Mathieu Le Gars, Johan Vingerhoets, Beatriz Grinsztejn, Paul A. Goepfert, Leonardo Paiva de Sousa, Mayara Secco Torres Silva, Martin Casapia, Marcelo H. Losso, Susan J. Little, Aditya Gaur, Linda-Gail Bekker, Nigel Garrett, Carla Truyers, Ilse Van Dromme, Edith Swann, Mary A. Marovich, Dean Follmann, Kathleen M. Neuzil, Lawrence Corey, Alexander L. Greninger, Pavitra Roychoudhury, Ollivier Hyrien, Peter B. Gilbert

Publikováno v: Nature Communications, Vol 15, Iss 1, Pp 1-22 (2024)

Abstract In the ENSEMBLE randomized, placebo-controlled phase 3 trial (NCT04505722), estimated single-dose Ad26.COV2.S vaccine efficacy (VE) was 56% against moderate to severe–critical COVID-19. SARS-CoV-2 Spike sequences were determined from 484 v

Externí odkaz: https://doaj.org/article/ae82624b40e944a5925f8f3c70ded9b7

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 study

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

Publikováno v: In eBioMedicine October 2024 108