Immunogenicity, reactogenicity and safety of a second booster with BNT162b2 or full-dose mRNA-1273: a randomised VACCELERATE trial in adults ≥75 years (EU-COVAT-1-AGED Part B).

SARS-CoV-2 advanced age anti-RBD IgG booster vaccination fourth dose immunosenescence neutralising antibodies variants of concern

Journal

International journal of infectious diseases : IJID : official publication of the International Society for Infectious Diseases
ISSN: 1878-3511
Titre abrégé: Int J Infect Dis
Pays: Canada
ID NLM: 9610933

Informations de publication

Date de publication:
09 Jul 2024
Historique:
received: 27 03 2024
revised: 12 06 2024
accepted: 29 06 2024
medline: 12 7 2024
pubmed: 12 7 2024
entrez: 11 7 2024
Statut: aheadofprint

Résumé

To assess safety and immunogenicity of a 4 269 participants (mean age 81 years, mRNA-1273 n=135/BNT162b2 n=134) were included. 2-fold anti-RBD IgG titre increase was achieved by 101/129 (78%) and 116/133 (87%) subjects in the BNT162b2 and the mRNA-1273 group, respectively (p=0.054). A 2 A 2

Identifiants

DOI: 10.1016/j.ijid.2024.107161 PMID: 38992789
pubmed: 38992789
pii: S1201-9712(24)00232-7
doi: 10.1016/j.ijid.2024.107161
pii:
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

107161

Informations de copyright

Copyright © 2024. Published by Elsevier Ltd.

Déclaration de conflit d'intérêts

Declaration of competing interest JS has received research grants by the German Federal Ministry of Education and Research (BMBF), Noscendo and Basilea Pharmaceuticals; has received speaker honoraria by AbbVie, Hikma, Pfizer and Gilead; has been a consultant to Gilead, Produkt&Markt GmbH, Alvea Vax and Micron Research and has received travel grants by German Society for Infectious Diseases (DGI) and Meta-Alexander Foundation, all outside the submitted work. LY no conflicts declared. CS no conflicts declared. KGIM no conflicts declared. AJCS no conflicts declared. ERR no conflicts declared. JMM no conflicts declared. IVM no conflicts declared. TW no conflicts declared. BZ no conflicts declared. MA has received research grants from Pfizer and Gilead. Contributed to educational activities organized/supported by Pfizer, Roche, Gilead, GSK, Moderna and Sanofi. All honoraria from these activities are paid to the Institution. UB no conflicts declared. SH no conflicts declared. JSG has received speaker honoraria from Gilead and Pfizer, outside of the submitted work. JJ no conflicts declared. LT no conflicts declared. MZ has received honoraria for lecturing courses by Pfizer Malaysia; is now an employee with AiCuris AG. AC no conflicts declared. LMB no conflicts declared. JG no conflicts declared. SCM no conflicts declared. JAN no conflicts declared. JN no conflicts declared. RS has received lecture honoraria from Pfizer and Hikma, outside of the submitted work. JFI has received research grants by the Instituto de Salud Carlos III, Ministry of Science. Spain. Has received grants or research contracts from Laboratorios Faes, Normon, Pfizer, Italfarmaco, GSK, Prestige, has been a consultant or has received speaker honoraria from Faes, Normon, Cinfa, Mundipharma, Abbott, Novartis and docency colaborations from Abbvie. RN no conflicts declared. CG no conflicts declared. GS no conflicts declared. AGL no conflicts declared. PWGM has received honoraria and/or grant funding from Gilead, Janssen, MSD, ViiV Healthcare, GSK and AstraZeneca, outside of the submitted work. CL no conflicts declared. AH no conflicts declared. KL no conflicts declared. SMK has received grants from Pfizer, MSD, Huvepharma, AiCuris, Astra Zeneca, Mylan, Janssen pharma. HG no conflicts declared. SKS no conflicts declared. FK no conflicts declared. MP no conflicts declared. PK reports grants or contracts from German Federal Ministry of Research and Education (BMBF) B-FAST (Bundesweites Forschungsnetz Angewandte Surveillance und Testung) and NAPKON (Nationales Pandemie Kohorten Netz, German National Pandemic Cohort Network) of the Network University Medicine (NUM) and the State of North Rhine-Westphalia; Consulting fees Ambu GmbH, Gilead Sciences, Mundipharma Resarch Limited, Noxxon N.V. and Pfizer Pharma; Honoraria for lectures from Akademie für Infektionsmedizin e.V., Ambu GmbH, Astellas Pharma, BioRad Laboratories Inc., Datamed GmbH, European Confederation of Medical Mycology, Gilead Sciences, GPR Academy Ruesselsheim, HELIOS Kliniken GmbH, Lahn-Dill-Kliniken GmbH, medupdate GmbH, MedMedia GmbH, MSD Sharp & Dohme GmbH, Pfizer Pharma GmbH, Scilink Comunicación Científica SC, streamedup! GmbH and University Hospital and LMU Munich; Participation on an Advisory Board from Ambu GmbH, Gilead Sciences, Mundipharma Resarch Limited and Pfizer Pharma; A pending patent currently reviewed at the German Patent and Trade Mark Office (DE 10 2021 113 007.7); Other non-financial interests from Elsevier, Wiley and Taylor & Francis online outside the submitted work. OAC reports grants or contracts from Amplyx, Basilea, BMBF, Cidara, DZIF, EU-DG RTD (101037867), F2G, Gilead, Matinas, MedPace, MSD, Mundipharma, Octapharma, Pfizer, Scynexis; Consulting fees from Abbvie, Amplyx, Biocon, Biosys, Cidara, Da Volterra, Gilead, IQVIA, Janssen, Matinas, MedPace, Menarini, Molecular Partners, MSG-ERC, Noxxon, Octapharma, Pfizer, PSI, Scynexis, Seres; Honoraria for lectures from Abbott, Abbvie, Al-Jazeera Pharmaceuticals, Astellas, Gilead, Grupo Biotoscana/United Medical/Knight, Hikma, MedScape, MedUpdate, Merck/MSD, Mylan, Noscendo, Pfizer, Shionogi; Payment for expert testimony from Cidara; Participation on a Data Safety Monitoring Board or Advisory Board from Actelion, Allecra, Cidara, Entasis, IQVIA, Janssen, MedPace, Paratek, PSI, Pulmocide, Shionogi, The Prime Meridian Group.

Auteurs

Jannik Stemler (J)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931 Cologne, Germany.

Lusine Yeghiazaryan (L)

Medical University of Vienna, Center for Medical Data Science, Institute of Medical Statistics, Spitalgasse 23, 1090 Vienna, Austria.

Christoph Stephan (C)

Department of Internal Medicine, Infectious Diseases, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany.

Kristin Greve-Isdahl Mohn (KG)

Helse Bergen HF, Haukeland University Hospital, Department Internal Medicine, Jonas Lies vei 65, 5021 Bergen, Norway.

Antonio-José Carcas-Sansuan (AJ)

Hospital La Paz, Clinical Pharmacology Service, Institute for Health Research (IdiPAZ), Universidad Autónoma de Madrid, Faculty of Medicine, Madrid, Spain.

Esperanza Romero Rodriguez (ER)

Distrito Sanitario Córdoba Guadalquivir, Primary Care Unit, Isla Lanzarote, s/n, Córdoba and Maimonides Biomedical Research Institute of Cordoba (IMIBIC), Reina Sofia University Hospital, University of Córdoba, Menendez Pidal s/n, 14004, Córdoba, Spain.

José Moltó (J)

Hospital Universitari Germans Trias i Pujol, at Ctra. de Canyet, s/n 08916 Badalona, Spain.

Itziar Vergara Mitxeltorena (IV)

Asociación Instituto BIODONOSTIA, Primary Care Research Unit of Gipuzkoa Integrated Health Organizations, Paseo Dr Beguiristain s/n 20014, San Sebastián, Gipuzkoa, Spain.

Tobias Welte (T)

Medizinische Hochschule Hannover, Klinik für Pneumologie, Carl-Neuberg-Straße 1, 30625 Hannover, Germany.

Birutė Zablockienė (B)

Centre of Infectious Diseases, Vilnius University Hospital Santaros Klinikos, Santariskiu 14, LT-08406 Vilnius, Lithuania and Clinic of Infectious Diseases and Dermatovenerology, Institute of Clinical Medicine, Vilnius University Faculty of Medicine, Vilnius University, M.K. Ciurlionio 21, LT, 03101 Vilnius, Lithuania.

Murat Akova (M)

Hacettepe University School of Medicine, Department of Infectious Diseases, Ankara, Turkey.

Ullrich Bethe (U)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931 Cologne, Germany.

Sarah Heringer (S)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931 Cologne, Germany.

Jon Salmanton-García (J)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931 Cologne, Germany.

Julia Jeck (J)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931 Cologne, Germany.

Lea Tischmann (L)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931 Cologne, Germany.

Marouan Zarrouk (M)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany.

Arnd Cüppers (A)

University of Cologne, Faculty of Medicine, Clinical Trials Centre Cologne (CTCC Cologne), Gleueler Str. 269, 50935 Cologne, Germany.

Lena M Biehl (LM)

University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931 Cologne, Germany.

Jan Grothe (J)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931 Cologne, Germany.

Sibylle C Mellinghoff (SC)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931 Cologne, Germany.

Julia A Nacov (JA)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931 Cologne, Germany.

Julia M Neuhann (JM)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931 Cologne, Germany.

Rosanne Sprute (R)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931 Cologne, Germany.

Jesús Frías-Iniesta (J)

Hospital La Paz, Clinical Pharmacology Service, Institute for Health Research (IdiPAZ), Universidad Autónoma de Madrid, Faculty of Medicine, Madrid, Spain.

Riya Negi (R)

Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Belfield, Dublin 4, Ireland.

Colette Gaillard (C)

Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Belfield, Dublin 4, Ireland.

Gurvin Saini (G)

Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Belfield, Dublin 4, Ireland.

Alejandro García León (AG)

Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Belfield, Dublin 4, Ireland.

Patrick W G Mallon (PWG)

Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Belfield, Dublin 4, Ireland.

Christine Lammens (C)

Laboratory of Medical Microbiology (LMM), Vaccine & Infectious Disease Institute and Biobank Antwerp, University of Antwerp, Universiteitsplein 1, 2610 Antwerpen, Belgium.

An Hotterbeekx (A)

Molecular Pathology Group, Laboratory of Cell Biology & Histology (CBH) and Vaccine & Infectious Disease Institute (CBH), Faculty of Medicine, University of Antwerp, Universiteitsplein 1, 2610 Antwerpen, Belgium.

Katherine Loens (K)

Laboratory of Medical Microbiology (LMM), Vaccine & Infectious Disease Institute and Biobank Antwerp, University of Antwerp, Universiteitsplein 1, 2610 Antwerpen, Belgium.

Surbhi Malhotra-Kumar (S)

Laboratory of Medical Microbiology (LMM), Vaccine & Infectious Disease Institute and Biobank Antwerp, University of Antwerp, Universiteitsplein 1, 2610 Antwerpen, Belgium.

Herman Goossens (H)

Laboratory of Medical Microbiology (LMM), Vaccine & Infectious Disease Institute and Biobank Antwerp, University of Antwerp, Universiteitsplein 1, 2610 Antwerpen, Belgium.

Samir Kumar-Singh (S)

Molecular Pathology Group, Laboratory of Cell Biology & Histology (CBH) and Vaccine & Infectious Disease Institute (CBH), Faculty of Medicine, University of Antwerp, Universiteitsplein 1, 2610 Antwerpen, Belgium.

Franz König (F)

Medical University of Vienna, Center for Medical Data Science, Institute of Medical Statistics, Spitalgasse 23, 1090 Vienna, Austria.

Martin Posch (M)

Medical University of Vienna, Center for Medical Data Science, Institute of Medical Statistics, Spitalgasse 23, 1090 Vienna, Austria.

Philipp Koehler (P)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany.

Oliver A Cornely (OA)

University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Herderstr. 52, 50931, Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Kerpener Str. 62, 50937 Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931 Cologne, Germany; University of Cologne, Faculty of Medicine, Clinical Trials Centre Cologne (CTCC Cologne), Gleueler Str. 269, 50935 Cologne, Germany. Electronic address: oliver.cornely@uk-koeln.de.

Classifications MeSH