Fulltext

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 J 1 , Yeghiazaryan L 2 , Stephan C 3 , Mohn KG 4 , Carcas-Sansuan AJ 5 , Rodriguez ER 6 Show all authors , Moltó J 7 , Mitxeltorena IV 8 , Welte T 9 , Zablockienė B 10 , Akova M 11 , Bethe U 1 , Heringer S 1 , Salmanton-García J 1 , Jeck J 1 , Tischmann L 1 , Zarrouk M 12 , Cüppers A 13 , Biehl LM 14 , Grothe J 1 , Mellinghoff SC 1 , Nacov JA 1 , Neuhann JM 1 , Sprute R 1 , Frías-Iniesta J 5 , Negi R 15 , Gaillard C 15 , Saini G 15 , León AG 15 , Mallon PWG 15 , Lammens C 16 , Hotterbeekx A 17 , Loens K 16 , Malhotra-Kumar S 16 , Goossens H 16 , Kumar-Singh S 17 , König F 2 , Posch M 2 , Koehler P 18 , Cornely OA 19 , EU-COVAT-1 AGED study group on behalf of the VACCELERATE consortium

Affiliations 

  • 1 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 Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn Cologne Department, Cologne, Germany
  • 2 Medical University of Vienna, Center for Medical Data Science, Institute of Medical Statistics, Vienna, Austria
  • 3 Department of Internal Medicine, Infectious Diseases, University Hospital Frankfurt, Frankfurt am Main, Germany
  • 4 Helse Bergen HF, Haukeland University Hospital, Department Internal Medicine, Bergen, Norway
  • 5 Hospital La Paz, Clinical Pharmacology Service, Institute for Health Research, Universidad Autónoma de Madrid, Faculty of Medicine, Madrid, Spain
  • 6 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
  • 7 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
  • 8 Asociación Instituto BIODONOSTIA, Primary Care Research Unit of Gipuzkoa Integrated Health Organizations, San Sebastián (Gipuzkoa), Spain
  • 9 Medizinische Hochschule Hannover, Klinik für Pneumologie, Hannover, Germany
  • 10 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
  • 11 Hacettepe University School of Medicine, Department of Infectious Diseases, Ankara, Turkey
  • 12 University of Cologne, Institute of Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), Cologne, Germany
  • 13 University of Cologne, Faculty of Medicine, Clinical Trials Centre Cologne (CTCC Cologne), Cologne, Germany
  • 14 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), Partner Site Bonn Cologne Department, Cologne, Germany
  • 15 Centre for Experimental Pathogen Host Research (CEPHR), School of Medicine, University College Dublin (UCD), Dublin, Ireland
  • 16 Laboratory of Medical Microbiology (LMM), Vaccine & Infectious Disease Institute and BioBank Antwerp, University of Antwerp, Antwerpen, Belgium
  • 17 Molecular Pathology Group, Laboratory of Cell Biology & Histology (CBH) and Vaccine & Infectious Disease Institute (CBH), Faculty of Medicine, University of Antwerp, Antwerpen, Belgium
  • 18 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 Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Cologne, Germany
  • 19 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 Integrated Oncology Aachen Bonn Cologne Duesseldorf (CIO ABCD) and Excellence Center for Medical Mycology (ECMM), Cologne, Germany; German Centre for Infection Research (DZIF), Partner Site Bonn Cologne Department, Cologne, Germany; University of Cologne, Faculty of Medicine, Clinical Trials Centre Cologne (CTCC Cologne), Cologne, Germany. Electronic address: oliver.cornely@uk-koeln.de
Int J Infect Dis, 2024 Jul 09;146:107161.
PMID: 38992789 DOI: 10.1016/j.ijid.2024.107161

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.

* Title and MeSH Headings from MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine.

Similar publications