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Open Access funding enabled and organized by Projekt DEAL. This project has received funding from the European Commission -Directorate-General for Research and Innovation under the Framework Program HORIZON 2020 under the VACCELERTE Grant Agreement (GA) and its annexes No. 101037867. The funders of the study had no role in study design, data collection, data analysis, data interpretation, or in the writing of the report.

Analysis of institutional authors

Carcas AAuthorFrías-Iniesta JAuthor

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October 10, 2022
Publications
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Clinical Trial
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A multinational, phase 2, randomised, adaptive protocol to evaluate immunogenicity and reactogenicity of different COVID-19 vaccines in adults ≥75 already vaccinated against SARS-CoV-2 (EU-COVAT-1-AGED): a trial conducted within the VACCELERATE network

Publicated to:Trials. 23 (1): 865-865 - 2022-10-08 23(1), DOI: 10.1186/s13063-022-06791-y

Authors: Neuhann JM, Stemler J, Carcas A, Frías-Iniesta J, Bethe U, Heringer S, Tischmann L, Zarrouk M, Cüppers A, König F, Posch M, Cornely OA

Affiliations

Center for Medical Statistics, Informatics, and Intelligent Systems Medical University of Vienna, Spitalgasse 23, 1090, Vienna, Austria. - Author
Faculty of Medicine and University Hospital Cologne, Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Herderstr. 52, 50931, Cologne, Germany. - Author
Faculty of Medicine and University Hospital Cologne, Translational Research, Cologne Excellence Cluster on Cellular Stress Responses in Aging-Associated Diseases (CECAD), University of Cologne, Herderstr. 52, 50931, Cologne, Germany. Oliver.Cornely@uk-koeln.de. - Author
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), University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany. - Author
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), University of Cologne, Kerpener Str. 62, 50937, Cologne, Germany. Oliver.Cornely@uk-koeln.de. - Author
Faculty of Medicine, Clinical Trials Centre Cologne (ZKS Köln), University of Cologne, Gleueler Str. 269, 50935, Cologne, Germany. - Author
Faculty of Medicine, Clinical Trials Centre Cologne (ZKS Köln), University of Cologne, Gleueler Str. 269, 50935, Cologne, Germany. Oliver.Cornely@uk-koeln.de. - Author
Faculty of Medicine, Hospital La Paz, Clinical Pharmacology Service. Institute for Health Research (IdiPAZ), Universidad Autónoma de Madrid, Madrid, Spain. - Author
German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931, Cologne, Germany. - Author
German Centre for Infection Research (DZIF), Partner Site Bonn-Cologne Department, Herderstr. 52, 50931, Cologne, Germany. Oliver.Cornely@uk-koeln.de. - Author
German Ctr Infect Res DZIF, Partner Site Bonn Cologne Dept,Herderstr 52, D-50931 Cologne, Germany - Author
Med Univ Vienna, Ctr Med Stat Informat & Intelligent Syst, Spitalgasse 23, A-1090 Vienna, Austria - Author
Univ Autonoma Madrid, Inst Hlth Res IdiPAZ, Clin Pharmacol Serv, Fac Med,Hosp La Paz, Madrid, Spain - Author
Univ Cologne, Clin Trials Ctr Cologne ZKS Koln, Fac Med, Gleueler Str 269, D-50935 Cologne, Germany - Author
Univ Cologne, Cologne Excellence Cluster Cellular Stress Respon, Translat Res, Fac Med, Herderstr 52, D-50931 Cologne, Germany - Author
Univ Cologne, Cologne Excellence Cluster Cellular Stress Respon, Translat Res, Univ Hosp Cologne, Herderstr 52, D-50931 Cologne, Germany - Author
Univ Cologne, Ctr Integrated Oncol Aachen Bonn Cologne Duesseld, Dept Internal Med, Fac Med, Kerpener Str 62, D-50937 Cologne, Germany - Author
Univ Cologne, Ctr Integrated Oncol Aachen Bonn Cologne Duesseld, Dept Internal Med, Univ Hosp Cologne, Kerpener Str 62, D-50937 Cologne, Germany - Author
Univ Cologne, Excellence Ctr Med Mycol ECMM, Kerpener Str 62, D-50937 Cologne, Germany - Author
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Abstract

In the ongoing COVID-19 pandemic, advanced age is a risk factor for a severe clinical course of SARS-CoV-2 infection. Thus, older people may benefit in particular from booster doses with potent vaccines and research should focus on optimal vaccination schedules. In addition to each individual's medical history, immunosenescence warrants further research in this population. This study investigates vaccine-induced immune response over 1 year.EU-COVAT-1-AGED is a randomised controlled, adaptive, multicentre phase II protocol evaluating different booster strategies in individuals aged ≥75 years (n=600) already vaccinated against SARS-CoV-2. The initial protocol foresaw a 3rd vaccination (1st booster) as study intervention. The present modified Part B of this trial foresees testing of mRNA-1273 (Spikevax®) vs. BNT162b2 (Comirnaty®) as 4th vaccination dose (2nd booster) for comparative assessment of their immunogenicity and safety against SARS-CoV-2 wild-type and variants. The primary endpoint of the trial is to assess the rate of 2-fold antibody titre increase 14 days after vaccination measured by quantitative enzyme-linked immunosorbent assay (Anti-RBD-ELISA) against wild-type virus. Secondary endpoints include the changes in neutralising antibody titres (Virus Neutralisation Assay) against wild-type as well as against Variants of Concern (VOC) at 14 days and up to 12 months. T cell response measured by qPCR will be performed in subgroups at 14 days as exploratory endpoint. Biobanking samples are being collected for neutralising antibody titres against potential future VOC. Furthermore, potential correlates between humoral immune response, T cell response and neutralising capacity will be assessed. The primary endpoint analysis will be triggered as soon as for all patients the primary endpoint (14 days after the 4th vaccination dose) has been observed.The EU-COVAT-1-AGED trial Part B compares immunogenicity and safety of mRNA-1273 (Spikevax®) and BNT162b2 (Comirnaty®) as 4th SARS-CoV-2 vaccine dose in adults ≥75 years of age. The findings of this trial have the potential to optimise the COVID-19 vaccination strategy for this at-risk population.ClinicalTrials.gov NCT05160766 . Registered on 16 December 2021.V06_0: 27 July 2022.© 2022. The Author(s).

Keywords

>= 75 yearsadvanced agebnt162b2 (comirnaty (r))boostercovid-19 vaccinationfourth doseimmunosenescencemrna-1273 (spikevax (r))phase iirandomisationvariants of concernvoc?75 yearsAdultAdvanced ageAdverse eventAgedAntibodies, neutralizingAntibodies, viralAntibody titerArticleBiobankBiological specimen banksBnt162 vaccineBnt162b2 (comirnaty®)Bnt162b2 (comirnaty®<sup>)</sup>BoosterClinical trials, phase ii as topicControlled studyCoronavirus disease 2019Covid-19Covid-19 vaccinationCovid-19 vaccinesDrug safetyElasomeranEnzyme linked immunosorbent assayFemaleFourth doseHumanHumansHumoral immunityImmune responseImmunosenescenceMaleMrna-1273 (spikevax®)Multicenter studyNeutralizing antibodyNonhumanPandemicPandemicsPhase 2 clinical trialPhase 2 clinical trial (topic)Phase iiPrevention and controlRandomisationRandomized controlled trialRandomized controlled trials as topicReal time polymerase chain reactionSars-cov-2Severe acute respiratory syndrome coronavirus 2T lymphocyteTozinameranVaccinationVaccineVaccine immunogenicityVaccine reactogenicityVaccinesVariant of concernVariants of concernVirus antibodyVirus neutralization testVoc≥75 years

Quality index

Bibliometric impact. Analysis of the contribution and dissemination channel

The work has been published in the journal Trials due to its progression and the good impact it has achieved in recent years, according to the agency Scopus (SJR), it has become a reference in its field. In the year of publication of the work, 2022, it was in position , thus managing to position itself as a Q2 (Segundo Cuartil), in the category Medicine (Miscellaneous). Notably, the journal is positioned en el Cuartil Q3 for the agency WoS (JCR) in the category Medicine, Research & Experimental.

From a relative perspective, and based on the normalized impact indicator calculated from World Citations from Scopus Elsevier, it yields a value for the Field-Weighted Citation Impact from the Scopus agency: 1.36, which indicates that, compared to works in the same discipline and in the same year of publication, it ranks as a work cited above average. (source consulted: ESI Nov 14, 2024)

This information is reinforced by other indicators of the same type, which, although dynamic over time and dependent on the set of average global citations at the time of their calculation, consistently position the work at some point among the top 50% most cited in its field:

  • Field Citation Ratio (FCR) from Dimensions: 4.02 (source consulted: Dimensions Jul 2025)

Specifically, and according to different indexing agencies, this work has accumulated citations as of 2025-07-18, the following number of citations:

  • WoS: 1
  • Scopus: 6
  • Europe PMC: 3

Impact and social visibility

From the perspective of influence or social adoption, and based on metrics associated with mentions and interactions provided by agencies specializing in calculating the so-called "Alternative or Social Metrics," we can highlight as of 2025-07-18:

  • The use, from an academic perspective evidenced by the Altmetric agency indicator referring to aggregations made by the personal bibliographic manager Mendeley, gives us a total of: 23.
  • The use of this contribution in bookmarks, code forks, additions to favorite lists for recurrent reading, as well as general views, indicates that someone is using the publication as a basis for their current work. This may be a notable indicator of future more formal and academic citations. This claim is supported by the result of the "Capture" indicator, which yields a total of: 31 (PlumX).

With a more dissemination-oriented intent and targeting more general audiences, we can observe other more global scores such as:

  • The Total Score from Altmetric: 49.75.
  • The number of mentions on the social network X (formerly Twitter): 3 (Altmetric).
  • The number of mentions in news outlets: 5 (Altmetric).

It is essential to present evidence supporting full alignment with institutional principles and guidelines on Open Science and the Conservation and Dissemination of Intellectual Heritage. A clear example of this is:

  • The work has been submitted to a journal whose editorial policy allows open Open Access publication.

Leadership analysis of institutional authors

This work has been carried out with international collaboration, specifically with researchers from: Austria; Germany.