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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).
Stemler, Jannik; Yeghiazaryan, Lusine; Stephan, Christoph; Mohn, Kristin Greve-Isdahl; Carcas-Sansuan, Antonio-José; Rodriguez, Esperanza Romero; Moltó, José; Mitxeltorena, Itziar Vergara; Welte, Tobias; Zablockiene, Birute; Akova, Murat; Bethe, Ullrich; Heringer, Sarah; Salmanton-García, Jon; Jeck, Julia; Tischmann, Lea; Zarrouk, Marouan; Cüppers, Arnd; Biehl, Lena M; Grothe, Jan; Mellinghoff, Sibylle C; Nacov, Julia A; Neuhann, Julia M; Sprute, Rosanne; Frías-Iniesta, Jesús; Negi, Riya; Gaillard, Colette; Saini, Gurvin; León, Alejandro García; Mallon, Patrick W G; Lammens, Christine; Hotterbeekx, An; Loens, Katherine; Malhotra-Kumar, Surbhi; Goossens, Herman; Kumar-Singh, Samir; König, Franz; Posch, Martin; Koehler, Philipp; Cornely, Oliver A.
Afiliação
  • 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 Medi
  • Yeghiazaryan L; Medical University of Vienna, Center for Medical Data Science, Institute of Medical Statistics, Spitalgasse 23, 1090 Vienna, Austria.
  • Stephan C; Department of Internal Medicine, Infectious Diseases, University Hospital Frankfurt, Theodor-Stern-Kai 7, 60590 Frankfurt am Main, Germany.
  • Mohn KG; Helse Bergen HF, Haukeland University Hospital, Department Internal Medicine, Jonas Lies vei 65, 5021 Bergen, Norway.
  • Carcas-Sansuan AJ; Hospital La Paz, Clinical Pharmacology Service, Institute for Health Research (IdiPAZ), Universidad Autónoma de Madrid, Faculty of Medicine, Madrid, Spain.
  • 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.
  • Moltó J; Hospital Universitari Germans Trias i Pujol, at Ctra. de Canyet, s/n 08916 Badalona, Spain.
  • Mitxeltorena IV; Asociación Instituto BIODONOSTIA, Primary Care Research Unit of Gipuzkoa Integrated Health Organizations, Paseo Dr Beguiristain s/n 20014, San Sebastián, Gipuzkoa, Spain.
  • Welte T; Medizinische Hochschule Hannover, Klinik für Pneumologie, Carl-Neuberg-Straße 1, 30625 Hannover, Germany.
  • Zablockiene 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
  • Akova M; Hacettepe University School of Medicine, Department of Infectious Diseases, Ankara, Turkey.
  • 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 Medi
  • 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 Medi
  • 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 Medi
  • 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 Medi
  • 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 Medi
  • 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.
  • Cüppers A; University of Cologne, Faculty of Medicine, Clinical Trials Centre Cologne (CTCC Cologne), Gleueler Str. 269, 50935 Cologne, Germany.
  • 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 Inf
  • 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 Medi
  • 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 Medi
  • 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 Medi
  • 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 Medi
  • 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 Medi
  • Frías-Iniesta J; Hospital La Paz, Clinical Pharmacology Service, Institute for Health Research (IdiPAZ), Universidad Autónoma de Madrid, Faculty of Medicine, Madrid, Spain.
  • Negi R; Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Belfield, Dublin 4, Ireland.
  • Gaillard C; Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Belfield, Dublin 4, Ireland.
  • Saini G; Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Belfield, Dublin 4, Ireland.
  • León AG; Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Belfield, Dublin 4, Ireland.
  • Mallon PWG; Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Belfield, Dublin 4, Ireland.
  • Lammens C; Laboratory of Medical Microbiology (LMM), Vaccine & Infectious Disease Institute and Biobank Antwerp, University of Antwerp, Universiteitsplein 1, 2610 Antwerpen, Belgium.
  • 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.
  • Loens K; Laboratory of Medical Microbiology (LMM), Vaccine & Infectious Disease Institute and Biobank Antwerp, University of Antwerp, Universiteitsplein 1, 2610 Antwerpen, Belgium.
  • Malhotra-Kumar S; Laboratory of Medical Microbiology (LMM), Vaccine & Infectious Disease Institute and Biobank Antwerp, University of Antwerp, Universiteitsplein 1, 2610 Antwerpen, Belgium.
  • Goossens H; Laboratory of Medical Microbiology (LMM), Vaccine & Infectious Disease Institute and Biobank Antwerp, University of Antwerp, Universiteitsplein 1, 2610 Antwerpen, Belgium.
  • 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.
  • König F; Medical University of Vienna, Center for Medical Data Science, Institute of Medical Statistics, Spitalgasse 23, 1090 Vienna, Austria.
  • Posch M; Medical University of Vienna, Center for Medical Data Science, Institute of Medical Statistics, Spitalgasse 23, 1090 Vienna, Austria.
  • 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 Medi
  • 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 Medi
Int J Infect Dis ; : 107161, 2024 Jul 09.
Article em En | MEDLINE | ID: mdl-38992789
ABSTRACT

OBJECTIVES:

To assess safety and immunogenicity of a 4th vaccination (2nd booster) in individuals ≥75 years

METHODS:

Participants were randomised to BNT162b2 (Comirnaty®, 30µg) or mRNA-1273 (Spikevax®, 100µg). The primary endpoint was the rate of 2-fold antibody titre increase 14 days post-vaccination targeting the receptor binding domain (RBD) region of wild-type SARS-CoV-2. Secondary endpoints included changes in neutralising activity against wild-type and 25 variants. Safety was assessed by monitoring solicited adverse events (AE) for seven days.

RESULTS:

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 2nd booster of mRNA-1273 provided higher anti-RBD IgG geometric mean titre 21.326 IU/mL (95%-CI 18.235; 24.940) vs. BNT162b2 15.181 IU/mL (95%-CI 13.172; 17.497). Higher neutralising activity was noted for the mRNA-1273 group. The most frequent AE was pain at injection site (51% in mRNA-1273 and 48% in BNT162b2). Participants in the mRNA-1273 group had less vaccine-related AEs (30% vs. 39%).

CONCLUSIONS:

A 2nd booster of either BNT162b2 or mRNA-1273 provided substantial IgG increase. Full-dose mRNA-1273 provided higher IGG levels and neutralising capacity against SARS-CoV-2 with similar safety profile for subjects of advanced age.
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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article
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Texto completo: 1 Base de dados: MEDLINE Idioma: En Ano de publicação: 2024 Tipo de documento: Article