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Immunogenicity, reactogenicity, and safety of a second booster with BNT162b2 or full-dose mRNA-1273: A randomized VACCELERATE trial in adults aged ≥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), Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integ
  • Yeghiazaryan L; Medical University of Vienna, Center for Medical Data Science, Institute of Medical Statistics, Vienna, Austria.
  • Stephan C; Department of Internal Medicine, Infectious Diseases, University Hospital Frankfurt, Frankfurt am Main, Germany.
  • Mohn KG; Helse Bergen HF, Haukeland University Hospital, Department Internal Medicine, Bergen, Norway; Influenza Centre, Department of Clinical Sciences, University of Bergen, Norway.
  • Carcas-Sansuan AJ; Hospital La Paz, Clinical Pharmacology Service, Institute for Health Research, 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 Córdoba(IMIBIC), Reina Sofia University Hospital, University of Córdoba, Córdoba, Spain.
  • Moltó J; Fundació Lluita Contra les Infeccions, Infectious Diseases Department, Hospital Universitari Germans Trias I Pujol, Badalona, Barcelona, Spain; CIBERINFEC, Instituto de Salud Carlos III, Madrid, Spain.
  • Mitxeltorena IV; Asociación Instituto BIODONOSTIA, Primary Care Research Unit of Gipuzkoa Integrated Health Organizations, San Sebastián (Gipuzkoa), Spain.
  • Welte T; Medizinische Hochschule Hannover, Klinik für Pneumologie, Hannover, Germany.
  • Zablockiene B; Centre of Infectious Diseases, Vilnius University Hospital Santaros Klinikos, Vilnius, Lithuania; Lithuania and Clinic of Infectious Diseases and Dermatovenerology, Institute of Clinical Medicine, Vilnius University Faculty of Medicine, Vilnius University, Vilnius, Lithuania.
  • 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), Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integ
  • Heringer S; University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integ
  • Salmanton-García J; University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integ
  • Jeck J; University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integ
  • Tischmann L; University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integ
  • Zarrouk M; University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany.
  • Cüppers A; University of Cologne, Faculty of Medicine, Clinical Trials Centre Cologne (CTCC Cologne), 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), Cologne, Germany; German Centre for Infection Research (DZIF),
  • Grothe J; University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integ
  • Mellinghoff SC; University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integ
  • Nacov JA; University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integ
  • Neuhann JM; University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integ
  • Sprute R; University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integ
  • Frías-Iniesta J; Hospital La Paz, Clinical Pharmacology Service, Institute for Health Research, 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), Dublin, Ireland.
  • Gaillard C; Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Dublin, Ireland.
  • Saini G; Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Dublin, Ireland.
  • León AG; Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Dublin, Ireland.
  • Mallon PWG; Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Dublin, Ireland.
  • Lammens C; Laboratory of Medical Microbiology (LMM), Vaccine & Infectious Disease Institute and BioBank Antwerp, University of Antwerp, 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, Antwerpen, Belgium.
  • Loens K; Laboratory of Medical Microbiology (LMM), Vaccine & Infectious Disease Institute and BioBank Antwerp, University of Antwerp, Antwerpen, Belgium.
  • Malhotra-Kumar S; Laboratory of Medical Microbiology (LMM), Vaccine & Infectious Disease Institute and BioBank Antwerp, University of Antwerp, Antwerpen, Belgium.
  • Goossens H; Laboratory of Medical Microbiology (LMM), Vaccine & Infectious Disease Institute and BioBank Antwerp, University of Antwerp, 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, Antwerpen, Belgium.
  • König F; Medical University of Vienna, Center for Medical Data Science, Institute of Medical Statistics, Vienna, Austria.
  • Posch M; Medical University of Vienna, Center for Medical Data Science, Institute of Medical Statistics, Vienna, Austria.
  • Koehler P; University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integ
  • Cornely OA; University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany; University of Cologne, Faculty of Medicine, and University Hospital Cologne, Department I of Internal Medicine, Center for Integ
Int J Infect Dis ; 146: 107161, 2024 Sep.
Article em En | MEDLINE | ID: mdl-38992789
ABSTRACT

OBJECTIVES:

To assess the safety and immunogenicity of a fourth vaccination (second booster) in individuals aged ≥75 years.

METHODS:

Participants were randomized to BNT162b2 (Comirnaty, 30 µg) or messenger RNA (mRNA)-1273 (Spikevax, 100 µg). The primary end point was the rate of two-fold antibody titer increase 14 days after vaccination, targeting the receptor binding domain (RBD) region of wild-type SARS-CoV-2. The secondary end points included changes in neutralizing activity against wild-type and 25 variants. Safety was assessed by monitoring solicited adverse events (AEs) for 7 days.

RESULTS:

A total of 269 participants (mean age 81 years, mRNA-1273 n = 135/BNT162b2 n = 134) were included. Two-fold anti-RBD immunoglobulin (Ig) G titer increase was achieved by 101 of 129 (78%) and 116 of 133 (87%) subjects in the BNT162b2 and the mRNA-1273 group, respectively (P = 0.054). A second booster of mRNA-1273 provided higher anti-RBD IgG geometric mean titer 21.326 IU/mL (95% confidence interval 18.235-24.940) vs BNT162b2 15.181 IU/mL (95% confidence interval 13.172-17.497). A higher neutralizing activity was noted for the mRNA-1273 group. The most frequent AE was pain at the 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 second booster of either BNT162b2 or mRNA-1273 provided substantial IgG increase. Full-dose mRNA-1273 provided higher IgG levels and neutralizing 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 Assunto principal: Imunização Secundária / Anticorpos Neutralizantes / Imunogenicidade da Vacina / SARS-CoV-2 / COVID-19 / Vacina BNT162 / Vacina de mRNA-1273 contra 2019-nCoV / Anticorpos Antivirais Limite: Aged / Aged80 / Female / Humans / Male Idioma: En Ano de publicação: 2024 Tipo de documento: Article
Texto completo
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Buscar no Google

Texto completo: 1 Base de dados: MEDLINE Assunto principal: Imunização Secundária / Anticorpos Neutralizantes / Imunogenicidade da Vacina / SARS-CoV-2 / COVID-19 / Vacina BNT162 / Vacina de mRNA-1273 contra 2019-nCoV / Anticorpos Antivirais Limite: Aged / Aged80 / Female / Humans / Male Idioma: En Ano de publicação: 2024 Tipo de documento: Article