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  • Bergman, PeterKarolinska Institutet (author)

Safety and efficacy of the mRNA BNT162b2 vaccine against SARS-CoV-2 in five groups of immunocompromised patients and healthy controls in a prospective open-label clinical trial

  • Article/chapterEnglish2021

Publisher, publication year, extent ...

  • Elsevier BV,2021
  • electronicrdacarrier

Numbers

  • LIBRIS-ID:oai:DiVA.org:umu-190106
  • https://urn.kb.se/resolve?urn=urn:nbn:se:umu:diva-190106URI
  • https://doi.org/10.1016/j.ebiom.2021.103705DOI
  • https://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-307157URI
  • http://kipublications.ki.se/Default.aspx?queryparsed=id:148443254URI

Supplementary language notes

  • Language:English
  • Summary in:English

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  • Subject category:ref swepub-contenttype
  • Subject category:art swepub-publicationtype

Notes

  • QC 20220127
  • Background: Patients with immunocompromised disorders have mainly been excluded from clinical trials of vaccination against COVID-19. Thus, the aim of this prospective clinical trial was to investigate safety and efficacy of BNT162b2 mRNA vaccination in five selected groups of immunocompromised patients and healthy controls.Methods: 539 study subjects (449 patients and 90 controls) were included. The patients had either primary (n=90), or secondary immunodeficiency disorders due to human immunodeficiency virus infection (n=90), allogeneic hematopoietic stem cell transplantation/CAR T cell therapy (n=90), solid organ transplantation (SOT) (n=89), or chronic lymphocytic leukemia (CLL) (n=90). The primary endpoint was seroconversion rate two weeks after the second dose. The secondary endpoints were safety and documented SARS-CoV-2 infection.Findings: Adverse events were generally mild, but one case of fatal suspected unexpected serious adverse reaction occurred. 72.2% of the immunocompromised patients seroconverted compared to 100% of the controls (p=0.004). Lowest seroconversion rates were found in the SOT (43.4%) and CLL (63.3%) patient groups with observed negative impact of treatment with mycophenolate mofetil and ibrutinib, respectively.Interpretation: The results showed that the mRNA BNT162b2 vaccine was safe in immunocompromised patients. Rate of seroconversion was substantially lower than in healthy controls, with a wide range of rates and antibody titres among predefined patient groups and subgroups. This clinical trial highlights the need for additional vaccine doses in certain immunocompromised patient groups to improve immunity.

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Added entries (persons, corporate bodies, meetings, titles ...)

  • Blennow, OlaKarolinska Institutet (author)
  • Hansson, LottaKarolinska Institutet (author)
  • Mielke, StephanKarolinska Institutet (author)
  • Nowak, PiotrKarolinska Institutet,Umeå universitet,Molekylär Infektionsmedicin, Sverige (MIMS),Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden; Department of Medicine Huddinge, Infectious Diseases, Karolinska Institutet, Stockholm, Sweden (author)
  • Chen, PuranDepartment of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden (author)
  • Söderdahl, GunnarDepartment of Transplantation, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden (author)
  • Österborg, AndersKarolinska Institutet (author)
  • Smith, C. I. EdvardKarolinska Institutet (author)
  • Wullimann, DavidDepartment of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden (author)
  • Vesterbacka, JanKarolinska Institutet (author)
  • Lindgren, GustafKarolinska Institutet (author)
  • Blixt, LisaKarolinska Institutet (author)
  • Friman, GustavDepartment of Transplantation, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden (author)
  • Wahren-Borgström, EmilieKarolinska Institutet (author)
  • Nordlander, AnnaKarolinska Institutet (author)
  • Gomez, Angelica CuapioDepartment of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden (author)
  • Akber, MiraDepartment of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden (author)
  • Valentini, DavideKarolinska Institutet (author)
  • Norlin, Anna-CarinDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden (author)
  • Thalme, AndersDepartment of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden (author)
  • Bogdanovic, GordanaDept of Clinical Microbiology, Karolinska University Hospital, Stockholm, Sweden (author)
  • Muschiol, SandraKarolinska Institutet (author)
  • Nilsson, PeterKTH,Science for Life Laboratory, SciLifeLab,Department of Protein Science, SciLifeLab, KTH Royal Institute of Technology, Stockholm, Sweden(Swepub:kth)u1ws88sk (author)
  • Hober, Sophia,Professor,1965-KTH,Science for Life Laboratory, SciLifeLab,Department of Protein Science, SciLifeLab, KTH Royal Institute of Technology, Stockholm, Sweden(Swepub:kth)u11qqzc1 (author)
  • Loré, KarinKarolinska Institutet (author)
  • Chen, Margaret SällbergDepartment of Dental Medicine, Karolinska Institutet, Stockholm, Sweden (author)
  • Buggert, MarcusKarolinska Institutet (author)
  • Ljunggren, Hans-GustafDepartment of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden (author)
  • Ljungman, PerKarolinska Institutet (author)
  • Aleman, SooKarolinska Institutet (author)
  • Karolinska InstitutetMolekylär Infektionsmedicin, Sverige (MIMS) (creator_code:org_t)

Related titles

  • In:EBioMedicine: Elsevier BV742352-3964

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