An open-label phase II trial of sotrovimab (VIR-7831) prophylaxis against COVID-19 infection in immunocompromised individuals with impaired SARS-CoV-2 humoral immunity
Background: Immunocompromised individuals have a limited humoral immune response to SARS-CoV-2 vaccination and are at higher risk of severe COVID-19. Sotrovimab is a monoclonal antibody (mAb) targeting a conserved SARS-CoV-2 spike protein epitope. Methods: This phase II open-label study evaluated th...
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Elsevier
2025-10-01
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| Series: | New Microbes and New Infections |
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| Online Access: | http://www.sciencedirect.com/science/article/pii/S2052297525000599 |
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| author | Isabel H. Gonzalez-Bocco Rayven Frierson Alyssa Cho Fabiola A. Reyes Curcio Andres E. Franceschi Chloe Lahoud Dimitrios G. Moshovitis Katherine Beluch Manu Balusu C. Elizabeth Keleher Keri M. Sullivan Michael Dougan Qianwen Wang Jennifer H. Han Ahmed Nader Alicia Aylott Wei Wang Brian T. Chan Sarah P. Hammond Jennifer Manne-Goehler Sophia Koo |
| author_facet | Isabel H. Gonzalez-Bocco Rayven Frierson Alyssa Cho Fabiola A. Reyes Curcio Andres E. Franceschi Chloe Lahoud Dimitrios G. Moshovitis Katherine Beluch Manu Balusu C. Elizabeth Keleher Keri M. Sullivan Michael Dougan Qianwen Wang Jennifer H. Han Ahmed Nader Alicia Aylott Wei Wang Brian T. Chan Sarah P. Hammond Jennifer Manne-Goehler Sophia Koo |
| author_sort | Isabel H. Gonzalez-Bocco |
| collection | DOAJ |
| description | Background: Immunocompromised individuals have a limited humoral immune response to SARS-CoV-2 vaccination and are at higher risk of severe COVID-19. Sotrovimab is a monoclonal antibody (mAb) targeting a conserved SARS-CoV-2 spike protein epitope. Methods: This phase II open-label study evaluated the safety and tolerability of sotrovimab pre-exposure prophylaxis in immunocompromised adults with impaired vaccine response. Between February and June 2022 in the northeastern region of the USA, participants received sotrovimab 500 mg IV on Treatment Day (TD) 1 and 2000 mg IV on TD2 due to the spread of the Omicron BA.2 subvariant. Follow-up lasted 36 weeks (∼5 half-lives), assessing safety and tolerability, PK, COVID-19 incidence and severity, and quality of life. Results: Ninety-three subjects received 500 mg on TD1, of whom 81 received 2000 mg on TD2. Three patients reported five drug-related adverse events, four grade 2 infusion-related reactions and one grade 2 headache, all resolving quickly. Among 35 SARS-CoV-2 cases, 94 % had no activity limitations or hospitalizations per the National Institute of Allergy and Infectious Diseases Ordinal Scale. Sotrovimab exhibited dose-dependent increases in exposures at doses of 500 mg and 2000 mg. Conclusion: Sotrovimab pre-exposure prophylaxis had a favorable safety profile and was well tolerated at both doses, with low immunogenicity. These findings support mAbs’ safety as COVID-19 pre-exposure prophylaxis in this population. |
| format | Article |
| id | doaj-art-a0de3176810548bca7340be5b4d0c0ef |
| institution | Kabale University |
| issn | 2052-2975 |
| language | English |
| publishDate | 2025-10-01 |
| publisher | Elsevier |
| record_format | Article |
| series | New Microbes and New Infections |
| spelling | doaj-art-a0de3176810548bca7340be5b4d0c0ef2025-08-20T05:06:20ZengElsevierNew Microbes and New Infections2052-29752025-10-016710162010.1016/j.nmni.2025.101620An open-label phase II trial of sotrovimab (VIR-7831) prophylaxis against COVID-19 infection in immunocompromised individuals with impaired SARS-CoV-2 humoral immunityIsabel H. Gonzalez-Bocco0Rayven Frierson1Alyssa Cho2Fabiola A. Reyes Curcio3Andres E. Franceschi4Chloe Lahoud5Dimitrios G. Moshovitis6Katherine Beluch7Manu Balusu8C. Elizabeth Keleher9Keri M. Sullivan10Michael Dougan11Qianwen Wang12Jennifer H. Han13Ahmed Nader14Alicia Aylott15Wei Wang16Brian T. Chan17Sarah P. Hammond18Jennifer Manne-Goehler19Sophia Koo20Division of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA; Division of Infectious Disease, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Corresponding author. 450 Brookline Ave Mayer Building, Floor 523 Boston, MA 02115, USA.Division of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA; Division of Infectious Disease, Dana-Farber Cancer Institute, Boston, MA, USADivision of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA; Division of Infectious Disease, Dana-Farber Cancer Institute, Boston, MA, USATufts Medical Center, Boston, MA, USADivision of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA; Division of Infectious Disease, Dana-Farber Cancer Institute, Boston, MA, USADepartment of Internal Medicine, Staten Island University Hospital, New York, USADivision of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA; Division of Infectious Disease, Dana-Farber Cancer Institute, Boston, MA, USAHospital of University of Pennsylvania, Philadelphia, USASaint Clare and Saint Mary Hospital, Passaic, NJ, USAGastroenterology Department, Massachusetts General Hospital, Boston, MA, USAGastroenterology Department, Massachusetts General Hospital, Boston, MA, USAHarvard Medical School, Boston, MA, USA; Gastroenterology Department, Massachusetts General Hospital, Boston, MA, USAGlaxoSmithKline, London, UKGlaxoSmithKline, Collegeville, PA, USAGlaxoSmithKline, Collegeville, PA, USAGlaxoSmithKline, Stevenage, UKHarvard Medical School, Boston, MA, USADivision of Infectious Disease, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USADivision of Infectious Disease, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Division of Infectious Disease, Massachusetts General Hospital, Boston, MA, USADivision of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA; Harvard Medical School, Boston, MA, USA; Division of Infectious Disease, Massachusetts General Hospital, Boston, MA, USADivision of Infectious Disease, Brigham and Women's Hospital, Boston, MA, USA; Division of Infectious Disease, Dana-Farber Cancer Institute, Boston, MA, USA; Harvard Medical School, Boston, MA, USABackground: Immunocompromised individuals have a limited humoral immune response to SARS-CoV-2 vaccination and are at higher risk of severe COVID-19. Sotrovimab is a monoclonal antibody (mAb) targeting a conserved SARS-CoV-2 spike protein epitope. Methods: This phase II open-label study evaluated the safety and tolerability of sotrovimab pre-exposure prophylaxis in immunocompromised adults with impaired vaccine response. Between February and June 2022 in the northeastern region of the USA, participants received sotrovimab 500 mg IV on Treatment Day (TD) 1 and 2000 mg IV on TD2 due to the spread of the Omicron BA.2 subvariant. Follow-up lasted 36 weeks (∼5 half-lives), assessing safety and tolerability, PK, COVID-19 incidence and severity, and quality of life. Results: Ninety-three subjects received 500 mg on TD1, of whom 81 received 2000 mg on TD2. Three patients reported five drug-related adverse events, four grade 2 infusion-related reactions and one grade 2 headache, all resolving quickly. Among 35 SARS-CoV-2 cases, 94 % had no activity limitations or hospitalizations per the National Institute of Allergy and Infectious Diseases Ordinal Scale. Sotrovimab exhibited dose-dependent increases in exposures at doses of 500 mg and 2000 mg. Conclusion: Sotrovimab pre-exposure prophylaxis had a favorable safety profile and was well tolerated at both doses, with low immunogenicity. These findings support mAbs’ safety as COVID-19 pre-exposure prophylaxis in this population.http://www.sciencedirect.com/science/article/pii/S2052297525000599Immunocompromised hostCovid-19Pre-exposure prophylaxisMonoclonal antibodies |
| spellingShingle | Isabel H. Gonzalez-Bocco Rayven Frierson Alyssa Cho Fabiola A. Reyes Curcio Andres E. Franceschi Chloe Lahoud Dimitrios G. Moshovitis Katherine Beluch Manu Balusu C. Elizabeth Keleher Keri M. Sullivan Michael Dougan Qianwen Wang Jennifer H. Han Ahmed Nader Alicia Aylott Wei Wang Brian T. Chan Sarah P. Hammond Jennifer Manne-Goehler Sophia Koo An open-label phase II trial of sotrovimab (VIR-7831) prophylaxis against COVID-19 infection in immunocompromised individuals with impaired SARS-CoV-2 humoral immunity New Microbes and New Infections Immunocompromised host Covid-19 Pre-exposure prophylaxis Monoclonal antibodies |
| title | An open-label phase II trial of sotrovimab (VIR-7831) prophylaxis against COVID-19 infection in immunocompromised individuals with impaired SARS-CoV-2 humoral immunity |
| title_full | An open-label phase II trial of sotrovimab (VIR-7831) prophylaxis against COVID-19 infection in immunocompromised individuals with impaired SARS-CoV-2 humoral immunity |
| title_fullStr | An open-label phase II trial of sotrovimab (VIR-7831) prophylaxis against COVID-19 infection in immunocompromised individuals with impaired SARS-CoV-2 humoral immunity |
| title_full_unstemmed | An open-label phase II trial of sotrovimab (VIR-7831) prophylaxis against COVID-19 infection in immunocompromised individuals with impaired SARS-CoV-2 humoral immunity |
| title_short | An open-label phase II trial of sotrovimab (VIR-7831) prophylaxis against COVID-19 infection in immunocompromised individuals with impaired SARS-CoV-2 humoral immunity |
| title_sort | open label phase ii trial of sotrovimab vir 7831 prophylaxis against covid 19 infection in immunocompromised individuals with impaired sars cov 2 humoral immunity |
| topic | Immunocompromised host Covid-19 Pre-exposure prophylaxis Monoclonal antibodies |
| url | http://www.sciencedirect.com/science/article/pii/S2052297525000599 |
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