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1. Identification and characterisation of SARS-CoV-2 and Human alphaherpesvirus 1 from a productive coinfection in a fatal COVID-19 case

Author

Alice Laschuk Herlinger, Fábio Luís Lima Monteiro, Mirela D’arc, Filipe Romero Rebello Moreira, Harrison James Westgarth, Rafael Mello Galliez, Diana Mariani, Luciana Jesus da Costa, Luiz Gonzaga Paula de Almeida, Carolina Moreira Voloch, Covid19-UFRJ Workgroup, Adriana Suely de Oliveira Melo, Renato Santana de Aguiar, André Felipe Andrade dos Santos, Terezinha Marta Pereira Pinto Castiñeiras, Ana Tereza Ribeiro de Vasconcelos, Esaú Custódio João Filho, Claudia Caminha Escosteguy, Orlando da Costa Ferreira Junior, Amilcar Tanuri, and Luiza Mendonça Higa

Subjects
SARS-CoV-2, COVID-19, HSV-1, coinfection, coronavirus, Microbiology, QR1-502, Infectious and parasitic diseases, RC109-216
Abstract

BACKGROUND During routine Coronavirus disease 2019 (COVID-19) diagnosis, an unusually high viral load was detected by reverse transcription real-time polymerase chain reaction (RT-qPCR) in a nasopharyngeal swab sample collected from a patient with respiratory and neurological symptoms who rapidly succumbed to the disease. Therefore we sought to characterise the infection. OBJECTIVES We aimed to determine and characterise the etiological agent responsible for the poor outcome. METHODS Classical virological methods, such as plaque assay and plaque reduction neutralisation test combined with amplicon-based sequencing, as well as a viral metagenomic approach, were performed to characterise the etiological agents of the infection. FINDINGS Plaque assay revealed two distinct plaque phenotypes, suggesting either the presence of two severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) strains or a productive coinfection of two different species of virus. Amplicon-based sequencing did not support the presence of any SARS-CoV-2 genetic variants that would explain the high viral load and suggested the presence of a single SARS-CoV-2 strain. Nonetheless, the viral metagenomic analysis revealed that Coronaviridae and Herpesviridae were the predominant virus families within the sample. This finding was confirmed by a plaque reduction neutralisation test and PCR. MAIN CONCLUSIONS We characterised a productive coinfection of SARS-CoV-2 and Herpes simplex virus 1 (HSV-1) in a patient with severe symptoms that succumbed to the disease. Although we cannot establish the causal relationship between the coinfection and the severity of the clinical case, this work serves as a warning for future studies focused on the interplay between SARS-CoV-2 and HSV-1 coinfection and COVID-19 severity.

Published
2022
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2. Efficacy, safety, and immunogenicity of a booster regimen of Ad26.COV2.S vaccine against COVID-19 (ENSEMBLE2): results of a randomised, double-blind, placebo-controlled, phase 3 trial

Author

Karin Hardt, An Vandebosch, Jerald Sadoff, Mathieu Le Gars, Carla Truyers, David Lowson, Ilse Van Dromme, Johan Vingerhoets, Tobias Kamphuis, Gert Scheper, Javier Ruiz-Guiñazú, Saul N Faust, Christoph D Spinner, Hanneke Schuitemaker, Johan Van Hoof, Macaya Douoguih, Frank Struyf, Brian T. Garibaldi, Timothy E. Albertson, Christian Sandrock, Janet S. Lee, Mark R. Looney, Victor F. Tapson, Charles Shey Wiysonge, Luis Humberto Anaya Velarde, Daniel Backenroth, Jisha Bhushanan, Börries Brandenburg, Vicky Cárdenas, Bohang Chen, Fei Chen, Polan Chetty, Pei-Ling Chu, Kimberly Cooper, Jerome Custers, Hilde Delanghe, Anna Duca, Tracy Henrick, Jarek Juraszek, Catherine Nalpas, Monika Peeters, Jose Pinheiro, Sanne Roels, Martin F. Ryser, Jose Salas, Samantha Santoro Matias, Ilse Scheys, Pallavi Shetty, Georgi Shukarev, Jeffrey Stoddard, Willem Talloen, NamPhuong Tran, Nathalie Vaissiere, Elisabeth van Son-Palmen, Jiajun Xu, Erin A. Goecker, Alexander L. Greninger, Keith R. Jerome, Pavitra Roychoudhury, Simbarashe G. Takuva, Jose Luis Accini Mendoza, Eric Achtyes, Habibul Ahsan, Azhar Alhatemi, Nancy Allen, Jose R. Arribas, Ghazaleh Bahrami, Lucia Bailon, Ali Bajwa, Jonathan Baker, Mira Baron, Susana Benet, Driss Berdaï, Patrick Berger, Todd Bertoch, Claire Bethune, Sybille Bevilacqua, Maria Silvia Biagioni Santos, Ian Binnian, Karen Bisnauthsing, Jean-Marc Boivin, Hilde Bollen, Sandrine Bonnet, Alberto M. Borobia, Elisabeth Botelho-Nevers, Phil Bright, Vianne Britten, Claire Brown, Amanda Buadi, Erik Buntinx, Lesley Burgess, Larry Bush, Maria Rosario Capeding, Quito Osuna Carr, Amparo Carrasco Mas, Hélène Catala, Katrina Cathie, T. Shawn Caudill, Fernando Cereto Castro, Kénora Chau, Steven Chavoustie, Marie Chowdhury, Nicolas Chronos, Paola Cicconi, Liliana Cifuentes, Sara Maria Cobo, Helen Collins, Hayley Colton, Carlos Rolando G. Cuaño, Valentino D'Onofrio, Paul Dargan, Thomas Darton, Peter Deane, Jose Luis Del Pozo, Inge Derdelinckx, Amisha Desai, Michael Dever, Beatriz Díaz-Pollán, Mark DiBuono, Matthew Doust, Christopher Duncan, Jose Maria Echave-Sustaeta, Frank Eder, Kimberly Ellis, Stanton Elzi, Stevan Emmett, Johannes Engelbrecht, Mim Evans, Theo Farah, Timothy Felton, João Pedro Ferreira, Catherine Floutier, Patrick Flume, Stacy Ford, Veronica Fragoso, Andrew Freedman, Emilia Frentiu, Christopher Galloway, Florence Galtier, Julia Garcia Diaz, Irene García García, Alcaide Garcia, Zoe Gardener, Pascale Gauteul, Steven Geller, Andrew Gibson, Claudia Gillet, Nicolas Girerd, Pierre-Olivier Girodet, Maria Tarcela Gler, Richard Glover, Herschel Don D. Go, Karishma Gokani, Damien Gonthier, Christopher Green, Richard Greenberg, Carl Griffin, Coert Grobbelaar, Adonis Guancia, Gloria Hakkarainen, James Harris, Michael Hassman, Deirdre Heimer, Elizabeth Hellstrom-Louw, Yoan Herades, Christopher Holroyd, Nazreen Hussen, Marie Grace Dawn Isidro, Yvonne Jackson, Manish Jain, Esaú Custódio João Filho, Daniel Johnson, Ben Jones, Natasha Joseph, Analyn Jumeras, Patricia Junquera, Johanna Kellett-Wright, Patrick Kennedy, Paul E. Kilgore, Kenneth Kim, Murray Kimmel, George Konis, Mark Kutner, Karine Lacombe, Odile Launay, Rajeka Lazarus, Samuel Lederman, Gigi Lefebvre, Katrina Lennon Collins, Isabel Leroux-Roels, Kenneth Wilson O. Lim, Muriel Lins, Edward Liu, Martin Llewelyn, Akbar Mahomed, Bernardo Porto Maia, Alícia Marín-Candon, Xavier Martínez-Gómez, Jean Benoit Martinot, Andrea Mazzella, Frank McCaughan, Louise McCormack, John McGettigan, Purvi Mehra, Rhonda Mejeur, Vicki Miller, Anthony Mills, Jose Molto Marhuenda, Prebashan Moodley, Marta Mora-Rillo, Beatriz Mothe, Daniel Mullan, Alasdair Munro, Paul Myers, Jeremy Nell, Tamara Newman Lobato Souza, Jane A. O'Halloran, Maria Dolores Ochoa Mazarro, Abigail Oliver, Jose Millan Onate Gutierrez, Jessica Ortega, Masaru Oshita, Susana Otero Romero, Jeffrey Scott Overcash, Daniel Owens, Alice Packham, Mihaela Pacurar, Leonardo Paiva de Sousa, Adrian Palfreeman, Christian José Pallares, Rahul Patel, Suchet Patel, Leslie Pelkey, Denise Peluso, Florentina Penciu, S. Jerry Pinto, Kevin Pounds, Joe Pouzar, Antoinette Pragalos, Rachel Presti, David Price, Ehsaan Qureshi, José Valdez Ramalho Madruga, Mayur Ramesh, Bruce Rankin, Béatrice Razat, Breno Riegel Santos, Robert Riesenberg, Ernie Riffer, Siobhan Roche, Katie Rose, Pietro Rosellini, Patrick Rossignol, Beth Safirstein, Hernan Salazar, Gregorio Sanchez Vallejo, Smrithi Santhosh, Enrique Seco-Meseguer, Michael Seep, Emma Sherry, Philip Short, Patrick Soentjens, Joel Solis, Alejandro Soriano Viladomiu, Caroline Sorli, Selwyn Spangenthal, Niamh Spence, Elaine Stephenson, Cynthia Strout, Ronald Surowitz, Kristy Michelle Taladua, David Tellalian, Claire Thalamas, Nang Thiriphoo, Judith Thomas, Nicholas Thomas, Guillermo Trout, Mikel Urroz, Bernard Veekmans, Laurent Veekmans, Ralph Elvi M. Villalobos, Sarah Warren, Brian Webster, Alexander White, Gail Williams, Hayes Williams, Barbara Wilson, Alan Winston, Martin Wiselka, and Marcus Zervos

Subjects
Adult, Vaccines, COVID-19 Vaccines, Immunogenicity, Vaccine, Infectious Diseases, Adolescent, Ad26COVS1, Double-Blind Method, SARS-CoV-2, Humans, COVID-19, Antibodies, Viral
Abstract

Despite the availability of effective vaccines against COVID-19, booster vaccinations are needed to maintain vaccine-induced protection against variant strains and breakthrough infections. This study aimed to investigate the efficacy, safety, and immunogenicity of the Ad26.COV2.S vaccine (Janssen) as primary vaccination plus a booster dose.ENSEMBLE2 is a randomised, double-blind, placebo-controlled, phase 3 trial including crossover vaccination after emergency authorisation of COVID-19 vaccines. Adults aged at least 18 years without previous COVID-19 vaccination at public and private medical practices and hospitals in Belgium, Brazil, Colombia, France, Germany, the Philippines, South Africa, Spain, the UK, and the USA were randomly assigned 1:1 via a computer algorithm to receive intramuscularly administered Ad26.COV2.S as a primary dose plus a booster dose at 2 months or two placebo injections 2 months apart. The primary endpoint was vaccine efficacy against the first occurrence of molecularly confirmed moderate to severe-critical COVID-19 with onset at least 14 days after booster vaccination, which was assessed in participants who received two doses of vaccine or placebo, were negative for SARS-CoV-2 by PCR at baseline and on serology at baseline and day 71, had no major protocol deviations, and were at risk of COVID-19 (ie, had no PCR-positive result or discontinued the study before day 71). Safety was assessed in all participants; reactogenicity, in terms of solicited local and systemic adverse events, was assessed as a secondary endpoint in a safety subset (approximately 6000 randomly selected participants). The trial is registered with ClinicalTrials.gov, NCT04614948, and is ongoing.Enrolment began on Nov 16, 2020, and the primary analysis data cutoff was June 25, 2021. From 34 571 participants screened, the double-blind phase enrolled 31 300 participants, 14 492 of whom received two doses (7484 in the Ad26.COV2.S group and 7008 in the placebo group) and 11 639 of whom were eligible for inclusion in the assessment of the primary endpoint (6024 in the Ad26.COV2.S group and 5615 in the placebo group). The median (IQR) follow-up post-booster vaccination was 36·0 (15·0-62·0) days. Vaccine efficacy was 75·2% (adjusted 95% CI 54·6-87·3) against moderate to severe-critical COVID-19 (14 cases in the Ad26.COV2.S group and 52 cases in the placebo group). Most cases were due to the variants alpha (B.1.1.7) and mu (B.1.621); endpoints for the primary analysis accrued from Nov 16, 2020, to June 25, 2021, before the global dominance of delta (B.1.617.2) or omicron (B.1.1.529). The booster vaccine exhibited an acceptable safety profile. The overall frequencies of solicited local and systemic adverse events (evaluated in the safety subset, n=6067) were higher among vaccine recipients than placebo recipients after the primary and booster doses. The frequency of solicited adverse events in the Ad26.COV2.S group were similar following the primary and booster vaccinations (local adverse events, 1676 [55·6%] of 3015 vs 896 [57·5%] of 1559, respectively; systemic adverse events, 1764 [58·5%] of 3015 vs 821 [52·7%] of 1559, respectively). Solicited adverse events were transient and mostly grade 1-2 in severity.A homologous Ad26.COV2.S booster administered 2 months after primary single-dose vaccination in adults had an acceptable safety profile and was efficacious against moderate to severe-critical COVID-19. Studies assessing efficacy against newer variants and with longer follow-up are needed.Janssen ResearchDevelopment.

Published
2022
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3. In-hospital mortality and severe outcomes after hospital discharge due to COVID-19: A prospective multicenter study from Brazil

Author

Hugo Perazzo, Sandra W. Cardoso, Maria Pia D. Ribeiro, Rodrigo Moreira, Lara E. Coelho, Emilia M. Jalil, André Miguel Japiassú, Elias Pimentel Gouvêa, Estevão Portela Nunes, Hugo Boechat Andrade, Luciano Barros Gouvêa, Marcel Treptow Ferreira, Pedro Mendes de Azambuja Rodrigues, Ronaldo Moreira, Kim Geraldo, Lucilene Freitas, Vinicius V. Pacheco, Esau Custódio João, Trevon Fuller, Verônica Diniz Rocha, Ceuci de Lima Xavier Nunes, Tâmara Newman Lobato Souza, Ana Luiza Castro Conde Toscano, Alexandre Vargas Schwarzbold, Helena Carolina Noal, Gustavo de Araujo Pinto, Paula Macedo de Oliveira Lemos, Carla Santos, Fernanda Carvalho de Queiroz Mello, Valdilea G. Veloso, and Beatriz Grinsztejn

Subjects
COVID-19, In-hospital mortality, Post-COVID-19, Public aspects of medicine, RA1-1270
Abstract

Summary: Background: We evaluated in-hospital mortality and outcomes incidence after hospital discharge due to COVID-19 in a Brazilian multicenter cohort. Methods: This prospective multicenter study (RECOVER-SUS, NCT04807699) included COVID-19 patients hospitalized in public tertiary hospitals in Brazil from June 2020 to March 2021. Clinical assessment and blood samples were performed at hospital admission, with post-hospital discharge remote visits. Hospitalized participants were followed-up until March 31, 2021. The outcomes were in-hospital mortality and incidence of rehospitalization or death after hospital discharge. Kaplan–Meier curves and Cox proportional-hazard models were performed. Findings: 1589 participants [54.5% male, age=62 (IQR 50-70) years; BMI=28.4 (IQR,24.9–32.9) Kg/m² and 51.9% with diabetes] were included. A total of 429 individuals [27.0% (95%CI,24.8–29.2)] died during hospitalization (median time 14 (IQR,9–24) days). Older age [vs

Published
2022
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