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1. Safety and immunogenicity of a variant-adapted SARS-CoV-2 recombinant protein vaccine with AS03 adjuvant as a booster in adults primed with authorized vaccines: a phase 3, parallel-group studyResearch in context

Author

Guy de Bruyn, Joyce Wang, Annie Purvis, Martin Sanchez Ruiz, Haritha Adhikarla, Saad Alvi, Matthew I. Bonaparte, Daniel Brune, Agustin Bueso, Richard M. Canter, Maria Angeles Ceregido, Sachin Deshmukh, David Diemert, Adam Finn, Remi Forrat, Bo Fu, Julie Gallais, Paul Griffin, Marie-Helene Grillet, Owen Haney, Jeffrey A. Henderson, Marguerite Koutsoukos, Odile Launay, Federico Martinon Torres, Roger Masotti, Nelson L. Michael, Juliana Park, Doris Maribel Rivera-Medina, Natalya Romanyak, Chris Rook, Lode Schuerman, Lawrence D. Sher, Fernanda Tavares-Da-Silva, Ashley Whittington, Roman M. Chicz, Sanjay Gurunathan, Stephen Savarino, Saranya Sridhar, Allaw Mohammed, Babin Valérie, Babyak Jennifer, Ines Ben-Ghezala, Thomas Breuer, Corinne Breymeier, Anne Conrad, Ciarrah Holmqvist, Cristiana Costa-Araujo, Florence Coux, Christine Dellanno, Bertrand Dussol, Brandon Essink, Jesús Garrido, Pierre-Olivier Girodet, Claudia Gonzalez, Marie-Ange Grosbois, Justin Hammond, Chelsea He, Ciarrah Homlqvist, Kathy Hudzina, Mark Hutchens, Peta-Gay Jackson Booth, Arnel Joaquin, Rama Kandasamy, Jennifer Kasztejna, Michael Keefer, Murray Kimmel, Matthew Kresge, Fabrice Laine, Maeva Lefebvre, Denise Lopez, Malaborbor Perpetua Lourdes, Zoha Maakaroun-Vermesse, Caitlin Malishchak, Lisa Menard, Sandra Mendoza, Patrick Moore, Mounika Mulamalla, Patrick Mulholland, Jean-Francois Nicolas, Onyema Ogbuagu, Juan Ortiz, Ana Paula Perroud, Gina Peyton, Ya-Fen Purvis, Vanessa Raabe, Enrique Rivas, Nadine Rouphael, Beatrice Roy, Lola Sagot, Nessryne Sater, Howard Schwartz, Randall Severance, Jiayuan Shi, Magdalena Sobieszczyk, Charlene Stevens, Tran Phuong Thuy, Ramy Toma, Tina Tong, Sophie Tourneux, John Treanor, Núria Turet, Rachel Froget, Stephen Walsh, Judith White, Victor del Campo Perez, Lina Perez Breva, Pablo Rojo Conejo, Maria Belen Ruiz Antoraz, Toong Chin, Charlotte Fribbens, Adrian Phillipson, Rachel Kaminski, Stevan Emmett, Corey Hebert, Thomas Birch, Russell Roberson, Jeffrey Zacher, Sophie Gelu-Maury, Loron Loryne, and Yvonne Davis

Subjects
AS03 adjuvant, Beta, Booster, B.1.351, COVID-19, CoV2 preS dTM-AS03, Medicine (General), R5-920
Abstract

Summary: Background: In a parallel-group, international, phase 3 study (ClinicalTrials.gov NCT04762680), we evaluated prototype (D614) and Beta (B.1.351) variant recombinant spike protein booster vaccines with AS03-adjuvant (CoV2 preS dTM-AS03). Methods: Adults, previously primed with mRNA (BNT162b2, mRNA-1273), adenovirus-vectored (Ad26.CoV2.S, ChAdOx1nCoV-19) or protein (CoV2 preS dTM-AS03 [monovalent D614; MV(D614)]) vaccines were enrolled between 29 July 2021 and 22 February 2022. Participants were stratified by age (18–55 and ≥ 56 years) and received one of the following CoV2 preS dTM-AS03 booster formulations: MV(D614) (n = 1285), MV(B.1.351) (n = 707) or bivalent D614 + B.1.351 (BiV; n = 625). Unvaccinated adults who tested negative on a SARS-CoV-2 rapid diagnostic test (control group, n = 479) received two primary doses, 21 days apart, of MV(D614). Anti-D614G and anti-B.1.351 antibodies were evaluated using validated pseudovirus (lentivirus) neutralization (PsVN) assay 14 days post-booster (day [D]15) in 18–55-year-old BNT162b2-primed participants and compared with those pre-booster (D1) and on D36 in 18–55-year-old controls (primary immunogenicity endpoints). PsVN titers to Omicron BA.1, BA.2 and BA.4/5 subvariants were also evaluated. Safety was evaluated over a 12-month follow-up period. Planned interim analyses are presented up to 14 days post-last vaccination for immunogenicity and over a median duration of 5 months for safety. Findings: All three boosters elicited robust anti-D614G or -B.1.351 PsVN responses for mRNA, adenovirus-vectored and protein vaccine-primed groups. Among BNT162b2-primed adults (18–55 years), geometric means of the individual post-booster versus pre-booster titer ratio (95% confidence interval [CI]) were: for MV (D614), 23.37 (18.58–29.38) (anti-D614G); for MV(B.1.351), 35.41 (26.71–46.95) (anti-B.1.351); and for BiV, 14.39 (11.39–18.28) (anti-D614G) and 34.18 (25.84–45.22 (anti-B.1.351). GMT ratios (98.3% CI) versus post-primary vaccination GMTs in controls, were: for MV(D614) booster, 2.16 (1.69; 2.75) [anti-D614G]; for MV(B.1.351), 1.96 (1.54; 2.50) [anti-B.1.351]; and for BiV, 2.34 (1.84; 2.96) [anti-D614G] and 1.39 (1.09; 1.77) [anti-B.1.351]. All booster formulations elicited cross-neutralizing antibodies against Omicron BA.2 (across priming vaccine subgroups), Omicron BA.1 (BNT162b2-primed participants) and Omicron BA.4/5 (BNT162b2-primed participants and MV D614-primed participants). Similar patterns in antibody responses were observed for participants aged ≥56 years. Reactogenicity tended to be transient and mild-to-moderate severity in all booster groups. No safety concerns were identified. Interpretation: CoV2 preS dTM-AS03 boosters demonstrated acceptable safety and elicited robust neutralizing antibodies against multiple variants, regardless of priming vaccine. Funding: Sanofi and Biomedical Advanced Research and Development Authority (BARDA).

Published
2023
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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

3. Acute toxicity from the synthetic cathinone

Author

Georgina, Blanco, Dan, Vidler, Clair, Roper, David M, Wood, Paul I, Dargan, Liza, Keating, Rebecca, Macfarlane, Stevan, Emmett, Graham, Johnson, Michael, Eddleston, Simon L, Hill, and Simon H L, Thomas

Subjects
Adult, Psychotropic Drugs, Alkaloids, Humans, Benzodioxoles, Butylamines, United Kingdom
Abstract

Acute toxicity caused by New Psychoactive Substances (NPS) has created a significant burden for Emergency Departments (EDs). Here we report characteristics of people presenting with toxicity after exposure to the synthetic cathinoneAdults presenting to hospital with severe acute toxicity after suspected NPS use were recruited between March 2015 and October 2020. Clinical features were recorded using consistent methodology and biological samples analysed using liquid chromatography-tandem mass-spectrometry.NEP was detected in at least one sample from 9 of 893 patients recruited during the period of study, all presenting between 2016 and 2019 and 8 presenting in southern England. Commonly reported clinical features included tachycardia (6), agitation (6), confusion (6), mydriasis (5), hallucinations (4), acidosis (3) and elevated creatine kinase (3). Co-used drugs, detected in 6 patients, may have contributed to these features, but agitation and hallucinations were also reported in all 3 patients without analytical evidence of co-use.NEP was detected infrequently in episodes of drug toxicity in the UK between 2016 and 2019, especially in southern England. Clinical characteristics of toxicity are similar to those of other cathinones, although co-use of other drugs is common and may contribute to the features observed.

Published
2021

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