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Safety and efficacy...
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
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- Bergman, Peter (författare)
- Karolinska Institutet
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- Blennow, Ola (författare)
- Karolinska Institutet
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- Hansson, Lotta (författare)
- Karolinska Institutet
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- Mielke, Stephan (författare)
- Karolinska Institutet
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- Nowak, Piotr (författare)
- Karolinska 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
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- Chen, Puran (författare)
- Department of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden
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- Söderdahl, Gunnar (författare)
- Department of Transplantation, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden
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- Österborg, Anders (författare)
- Karolinska Institutet
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- Smith, C. I. Edvard (författare)
- Karolinska Institutet
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- Wullimann, David (författare)
- Department of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden
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- Vesterbacka, Jan (författare)
- Karolinska Institutet
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- Lindgren, Gustaf (författare)
- Karolinska Institutet
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- Blixt, Lisa (författare)
- Karolinska Institutet
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- Friman, Gustav (författare)
- Department of Transplantation, Karolinska University Hospital, Stockholm, Sweden; Department of Clinical Science, Intervention and Technology, Karolinska Institutet, Stockholm, Sweden
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- Wahren-Borgström, Emilie (författare)
- Karolinska Institutet
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- Nordlander, Anna (författare)
- Karolinska Institutet
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- Gomez, Angelica Cuapio (författare)
- Department of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden
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- Akber, Mira (författare)
- Department of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden
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- Valentini, Davide (författare)
- Karolinska Institutet
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- Norlin, Anna-Carin (författare)
- Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden
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- Thalme, Anders (författare)
- Department of Infectious Diseases, Karolinska University Hospital, Stockholm, Sweden
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- Bogdanovic, Gordana (författare)
- Dept of Clinical Microbiology, Karolinska University Hospital, Stockholm, Sweden
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- Muschiol, Sandra (författare)
- Karolinska Institutet
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- Nilsson, Peter (författare)
- KTH,Science for Life Laboratory, SciLifeLab,Department of Protein Science, SciLifeLab, KTH Royal Institute of Technology, Stockholm, Sweden
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- Hober, Sophia, Professor, 1965- (författare)
- KTH,Science for Life Laboratory, SciLifeLab,Department of Protein Science, SciLifeLab, KTH Royal Institute of Technology, Stockholm, Sweden
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- Loré, Karin (författare)
- Karolinska Institutet
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- Chen, Margaret Sällberg (författare)
- Department of Dental Medicine, Karolinska Institutet, Stockholm, Sweden
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- Buggert, Marcus (författare)
- Karolinska Institutet
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- Ljunggren, Hans-Gustaf (författare)
- Department of Medicine Huddinge, Center for Infectious Medicine, Karolinska Institutet, Stockholm, Sweden
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- Ljungman, Per (författare)
- Karolinska Institutet
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- Aleman, Soo (författare)
- Karolinska Institutet
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(creator_code:org_t)
- Elsevier BV, 2021
- 2021
- Engelska.
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Ingår i: EBioMedicine. - : Elsevier BV. - 2352-3964. ; 74
- Relaterad länk:
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https://doi.org/10.1...
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https://umu.diva-por... (primary) (Raw object)
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http://www.thelancet...
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https://urn.kb.se/re...
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https://doi.org/10.1...
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https://urn.kb.se/re...
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http://kipublication...
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Abstract
Ämnesord
Stäng
- 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.
Ämnesord
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Infektionsmedicin (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Infectious Medicine (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Klinisk medicin -- Hematologi (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Clinical Medicine -- Hematology (hsv//eng)
- MEDICIN OCH HÄLSOVETENSKAP -- Medicinska och farmaceutiska grundvetenskaper -- Immunologi inom det medicinska området (hsv//swe)
- MEDICAL AND HEALTH SCIENCES -- Basic Medicine -- Immunology in the medical area (hsv//eng)
Nyckelord
- CAR-T
- chronic lymphocytic leukemia
- HIV
- human stem-cell transplantation
- Immunocompromised patients
- mRNA BNT162b2 vaccine
- Primary Immunodeficiency
- solid organ transplantation
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- ref (ämneskategori)
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Till lärosätets databas
- Av författaren/redakt...
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Bergman, Peter
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Blennow, Ola
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Hansson, Lotta
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Mielke, Stephan
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Nowak, Piotr
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Chen, Puran
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visa fler...
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Söderdahl, Gunna ...
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Österborg, Ander ...
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Smith, C. I. Edv ...
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Wullimann, David
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Vesterbacka, Jan
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Lindgren, Gustaf
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Blixt, Lisa
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Friman, Gustav
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Wahren-Borgström ...
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Nordlander, Anna
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Gomez, Angelica ...
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Akber, Mira
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Valentini, David ...
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Norlin, Anna-Car ...
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Thalme, Anders
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Bogdanovic, Gord ...
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Muschiol, Sandra
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Nilsson, Peter
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Hober, Sophia, P ...
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Loré, Karin
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Chen, Margaret S ...
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Buggert, Marcus
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Ljunggren, Hans- ...
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Ljungman, Per
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Aleman, Soo
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- Om ämnet
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Infektionsmedici ...
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Klinisk medicin
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och Hematologi
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- MEDICIN OCH HÄLSOVETENSKAP
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MEDICIN OCH HÄLS ...
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och Medicinska och f ...
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och Immunologi inom ...
- Artiklar i publikationen
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EBioMedicine
- Av lärosätet
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Umeå universitet
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Kungliga Tekniska Högskolan
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Karolinska Institutet