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
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 pati...
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Elsevier
2021
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oai:doaj.org-article:4718ffd4f65749848e9d9b7f48c73d1b2021-12-02T05:01:55ZSafety 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 trial2352-396410.1016/j.ebiom.2021.103705https://doaj.org/article/4718ffd4f65749848e9d9b7f48c73d1b2021-12-01T00:00:00Zhttp://www.sciencedirect.com/science/article/pii/S2352396421004990https://doaj.org/toc/2352-3964Background: 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. Funding: Knut and Alice Wallenberg Foundation, the Swedish Research Council, Nordstjernan AB, Region Stockholm, Karolinska Institutet, and organizations for PID/CLL-patients in Sweden.Peter Bergman, MDOla Blennow, MDLotta Hansson, MDStephan Mielke, MDPiotr Nowak, MDPuran Chen, MDGunnar Söderdahl, MDAnders Österborg, MDC. I. Edvard Smith, MDDavid Wullimann, MScJan Vesterbacka, MDGustaf Lindgren, MDLisa Blixt, MDGustav Friman, MDEmilie Wahren-Borgström, MDAnna Nordlander, MDAngelica Cuapio Gomez, MDMira Akber, MDDavide Valentini, MDAnna-Carin Norlin, MDAnders Thalme, MDGordana Bogdanovic, MDSandra Muschiol, MDPeter Nilsson, MDSophia Hober, MDKarin Loré, MDMargaret Sällberg Chen, MDMarcus Buggert, MDHans-Gustaf Ljunggren, MDPer Ljungman, MDSoo Aleman, MDElsevierarticlemRNA BNT162b2 vaccineImmunocompromised patientsPrimary ImmunodeficiencyHIVhuman stem-cell transplantationCAR-TMedicineRMedicine (General)R5-920ENEBioMedicine, Vol 74, Iss , Pp 103705- (2021) |
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mRNA BNT162b2 vaccine Immunocompromised patients Primary Immunodeficiency HIV human stem-cell transplantation CAR-T Medicine R Medicine (General) R5-920 |
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mRNA BNT162b2 vaccine Immunocompromised patients Primary Immunodeficiency HIV human stem-cell transplantation CAR-T Medicine R Medicine (General) R5-920 Peter Bergman, MD Ola Blennow, MD Lotta Hansson, MD Stephan Mielke, MD Piotr Nowak, MD Puran Chen, MD Gunnar Söderdahl, MD Anders Österborg, MD C. I. Edvard Smith, MD David Wullimann, MSc Jan Vesterbacka, MD Gustaf Lindgren, MD Lisa Blixt, MD Gustav Friman, MD Emilie Wahren-Borgström, MD Anna Nordlander, MD Angelica Cuapio Gomez, MD Mira Akber, MD Davide Valentini, MD Anna-Carin Norlin, MD Anders Thalme, MD Gordana Bogdanovic, MD Sandra Muschiol, MD Peter Nilsson, MD Sophia Hober, MD Karin Loré, MD Margaret Sällberg Chen, MD Marcus Buggert, MD Hans-Gustaf Ljunggren, MD Per Ljungman, MD Soo Aleman, MD 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 |
| description |
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. Funding: Knut and Alice Wallenberg Foundation, the Swedish Research Council, Nordstjernan AB, Region Stockholm, Karolinska Institutet, and organizations for PID/CLL-patients in Sweden. |
| format |
article |
| author |
Peter Bergman, MD Ola Blennow, MD Lotta Hansson, MD Stephan Mielke, MD Piotr Nowak, MD Puran Chen, MD Gunnar Söderdahl, MD Anders Österborg, MD C. I. Edvard Smith, MD David Wullimann, MSc Jan Vesterbacka, MD Gustaf Lindgren, MD Lisa Blixt, MD Gustav Friman, MD Emilie Wahren-Borgström, MD Anna Nordlander, MD Angelica Cuapio Gomez, MD Mira Akber, MD Davide Valentini, MD Anna-Carin Norlin, MD Anders Thalme, MD Gordana Bogdanovic, MD Sandra Muschiol, MD Peter Nilsson, MD Sophia Hober, MD Karin Loré, MD Margaret Sällberg Chen, MD Marcus Buggert, MD Hans-Gustaf Ljunggren, MD Per Ljungman, MD Soo Aleman, MD |
| author_facet |
Peter Bergman, MD Ola Blennow, MD Lotta Hansson, MD Stephan Mielke, MD Piotr Nowak, MD Puran Chen, MD Gunnar Söderdahl, MD Anders Österborg, MD C. I. Edvard Smith, MD David Wullimann, MSc Jan Vesterbacka, MD Gustaf Lindgren, MD Lisa Blixt, MD Gustav Friman, MD Emilie Wahren-Borgström, MD Anna Nordlander, MD Angelica Cuapio Gomez, MD Mira Akber, MD Davide Valentini, MD Anna-Carin Norlin, MD Anders Thalme, MD Gordana Bogdanovic, MD Sandra Muschiol, MD Peter Nilsson, MD Sophia Hober, MD Karin Loré, MD Margaret Sällberg Chen, MD Marcus Buggert, MD Hans-Gustaf Ljunggren, MD Per Ljungman, MD Soo Aleman, MD |
| author_sort |
Peter Bergman, MD |
| title |
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 |
| title_short |
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 |
| title_full |
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 |
| title_fullStr |
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 |
| title_full_unstemmed |
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 |
| title_sort |
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 |
| publisher |
Elsevier |
| publishDate |
2021 |
| url |
https://doaj.org/article/4718ffd4f65749848e9d9b7f48c73d1b |
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