“REAl LIfe” observational study on the effectiveness of Evusheld prophylaxis against SARS-CoV-2 omicron variants in vaccine non-responder immunocompromised patients (REALISE)
Background: Infection by SARS-CoV2 has become a challenge, especially for immunocompromised patients who show a weaker humoral response to COVID-19 vaccine. Tixagevimab+cilgavimab (Evusheld) is a combination of human monoclonal antibodies that can be used for pre-exposure prophylaxis to prevent infe...
Gespeichert in:
Veröffentlicht in: | Vaccine 2024-10, Vol.42 (23), p.126208, Article 126208 |
---|---|
Hauptverfasser: | , , , , , , , , , , , , , , , |
Format: | Artikel |
Sprache: | eng |
Schlagworte: | |
Online-Zugang: | Volltext |
Tags: |
Tag hinzufügen
Keine Tags, Fügen Sie den ersten Tag hinzu!
|
container_end_page | |
---|---|
container_issue | 23 |
container_start_page | 126208 |
container_title | Vaccine |
container_volume | 42 |
creator | Esposito, Giuliana Lucia Fassio, Federico Girardi, Daniela Picasso, Erica Meloni, Federica Montini, Simone Codullo, Veronica Pattonieri, Eleonora Francesca Defrancesco, Irene Bianchessi, Antonio Calvi, Monica Seminari, Elena Maria Baldanti, Fausto Lilleri, Daniele Novelli, Viola Marena, Carlo |
description | Background: Infection by SARS-CoV2 has become a challenge, especially for immunocompromised patients who show a weaker humoral response to COVID-19 vaccine. Tixagevimab+cilgavimab (Evusheld) is a combination of human monoclonal antibodies that can be used for pre-exposure prophylaxis to prevent infection or disease by SARS-CoV2. Objectives: Our study aimed to investigate the effectiveness of Evusheld by comparing an Exposed and an Unexposed group. Study design: Immunocompromised patients were enrolled in the Evusheld Group between March and September 2022. All patients had anti-spike IgG antibody levels |
doi_str_mv | 10.1016/j.vaccine.2024.126208 |
format | Article |
fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_3094469483</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><els_id>S0264410X24008909</els_id><sourcerecordid>3103224674</sourcerecordid><originalsourceid>FETCH-LOGICAL-c318t-ef8ea0e3ff29e9990b8a4e6038bd2edeccbe182b959987159ae5ca0b100b5cfb3</originalsourceid><addsrcrecordid>eNqFkU-O0zAYxSMEYsrAEUCW2AyLFP9LGq9QVZWhUiWkKSB2luN8pq4Su9hJNN3NQZhLcKQ5CS4tLNiw8rf4veen97LsJcFTgkn5djcdldbWwZRiyqeElhRXj7IJqWYspwWpHmcTTEuec4K_XmTPYtxhjAtGxNPsgglS8IKwSfbz4e7HzXLeovXKwMPdPfJ1hDCq3nqnWhT7oTkg71C_BQTGgO7tCA5iRN6g5TjELbQN2ge_3x5adWsjUt-UdbFHm_nNJl_4LzlFvrM6JJNRBatcH5E93r_TI-ddHiDuvWsgINt1g_Pad8mxsxGSdYoCR81VirlebZZvnmdPjGojvDi_l9nn98tPiw_5-uP1ajFf55qRqs_BVKAwMGOoACEErivFocSsqhsKDWhdA6loLQohqhkphIJCK1wTjOtCm5pdZlcn35Tl-wCxlymRhrZVDvwQJcOC81LwiiX09T_ozg8hFZgoghmlvJzxRBUnKpURYwAj98F2KhwkwfI4qtzJcy3yOKo8jZp0r87uQ91B81f1Z8UEvDsBkOoYLQQZdSpNQ2NDWkw23v7ni1_bpbpq</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>3103224674</pqid></control><display><type>article</type><title>“REAl LIfe” observational study on the effectiveness of Evusheld prophylaxis against SARS-CoV-2 omicron variants in vaccine non-responder immunocompromised patients (REALISE)</title><source>MEDLINE</source><source>Elsevier ScienceDirect Journals Complete</source><source>ProQuest Central UK/Ireland</source><creator>Esposito, Giuliana Lucia ; Fassio, Federico ; Girardi, Daniela ; Picasso, Erica ; Meloni, Federica ; Montini, Simone ; Codullo, Veronica ; Pattonieri, Eleonora Francesca ; Defrancesco, Irene ; Bianchessi, Antonio ; Calvi, Monica ; Seminari, Elena Maria ; Baldanti, Fausto ; Lilleri, Daniele ; Novelli, Viola ; Marena, Carlo</creator><creatorcontrib>Esposito, Giuliana Lucia ; Fassio, Federico ; Girardi, Daniela ; Picasso, Erica ; Meloni, Federica ; Montini, Simone ; Codullo, Veronica ; Pattonieri, Eleonora Francesca ; Defrancesco, Irene ; Bianchessi, Antonio ; Calvi, Monica ; Seminari, Elena Maria ; Baldanti, Fausto ; Lilleri, Daniele ; Novelli, Viola ; Marena, Carlo</creatorcontrib><description>Background: Infection by SARS-CoV2 has become a challenge, especially for immunocompromised patients who show a weaker humoral response to COVID-19 vaccine. Tixagevimab+cilgavimab (Evusheld) is a combination of human monoclonal antibodies that can be used for pre-exposure prophylaxis to prevent infection or disease by SARS-CoV2. Objectives: Our study aimed to investigate the effectiveness of Evusheld by comparing an Exposed and an Unexposed group. Study design: Immunocompromised patients were enrolled in the Evusheld Group between March and September 2022. All patients had anti-spike IgG antibody levels <260 BAU/ml before administration of Evusheld. Blood samples for serological evaluations were collected, and anti-Spike antibodies were tested. For the Unexposed Group, a serologic test was performed at enrollment and a questionnaire was performed after 6 months. Results: 43 patients received Evusheld pre-exposure prophylaxis and 45 patients not receiving Evusheld were enrolled in the Unexposed group. The median age was 59.0 years in the Evusheld group, and 63.0 in the unexposed group. In the Evusheld group, during the Omicron wave in Italy, 23.3% of subjects developed symptomatic infection compared to 42.2% in the unexposed group. A majority of infections was seen in male respect to female patients. No difference in length of infection between the groups was seen. Antibody level remained higher than the basal threshold at 180 days from enrollment. Conclusions: Evusheld seems to reduce the rate of symptomatic infection in immunocompromised patients. Further data are required to determine whether this prophylaxis may have a longer-lasting effect over time.
•Immunocompromised patients: weaker humoral response to Sars-CoV-2 vaccine.•Human monoclonal antibodies for pre-exposure prophylaxis.•Difference Sars-CoV-2 infection rate between males and females•Likely effectiveness of tixagevimab+cilgavimab in reducing symptomatic infection rate in immunocompromised patients.</description><identifier>ISSN: 0264-410X</identifier><identifier>ISSN: 1873-2518</identifier><identifier>EISSN: 1873-2518</identifier><identifier>DOI: 10.1016/j.vaccine.2024.126208</identifier><identifier>PMID: 39154513</identifier><language>eng</language><publisher>Netherlands: Elsevier Ltd</publisher><subject>Adult ; Aged ; Antibodies ; Antibodies, Monoclonal, Humanized - immunology ; Antibodies, Monoclonal, Humanized - therapeutic use ; Antibodies, Viral - blood ; Antibodies, Viral - immunology ; COVID-19 ; COVID-19 - immunology ; COVID-19 - prevention & control ; COVID-19 vaccines ; COVID-19 Vaccines - administration & dosage ; COVID-19 Vaccines - immunology ; Disease prevention ; Effectiveness ; Enrollments ; Evusheld ; Exposure ; Female ; Hematology ; Humans ; IgG antibody ; Immune response (humoral) ; Immune system ; Immunity (Disease) ; Immunocompromised Host ; Immunocompromised hosts ; Immunocompromised patients ; Immunoglobulin G ; Immunoglobulin G - blood ; Infections ; Male ; Middle Aged ; Monoclonal antibodies ; Observational studies ; Patients ; Pre-Exposure Prophylaxis - methods ; Prophylaxis ; Questionnaires ; SARS-CoV-2 - immunology ; Serology ; Severe acute respiratory syndrome coronavirus 2 ; Spike Glycoprotein, Coronavirus - immunology ; Transplants & implants ; Vaccination ; Vaccines ; Viral diseases</subject><ispartof>Vaccine, 2024-10, Vol.42 (23), p.126208, Article 126208</ispartof><rights>2024 Elsevier Ltd</rights><rights>Copyright © 2024 Elsevier Ltd. All rights reserved.</rights><rights>2024. Elsevier Ltd</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c318t-ef8ea0e3ff29e9990b8a4e6038bd2edeccbe182b959987159ae5ca0b100b5cfb3</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktohtml>$$Uhttps://www.proquest.com/docview/3103224674?pq-origsite=primo$$EHTML$$P50$$Gproquest$$H</linktohtml><link.rule.ids>314,780,784,3550,27924,27925,45995,64385,64387,64389,72469</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/39154513$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Esposito, Giuliana Lucia</creatorcontrib><creatorcontrib>Fassio, Federico</creatorcontrib><creatorcontrib>Girardi, Daniela</creatorcontrib><creatorcontrib>Picasso, Erica</creatorcontrib><creatorcontrib>Meloni, Federica</creatorcontrib><creatorcontrib>Montini, Simone</creatorcontrib><creatorcontrib>Codullo, Veronica</creatorcontrib><creatorcontrib>Pattonieri, Eleonora Francesca</creatorcontrib><creatorcontrib>Defrancesco, Irene</creatorcontrib><creatorcontrib>Bianchessi, Antonio</creatorcontrib><creatorcontrib>Calvi, Monica</creatorcontrib><creatorcontrib>Seminari, Elena Maria</creatorcontrib><creatorcontrib>Baldanti, Fausto</creatorcontrib><creatorcontrib>Lilleri, Daniele</creatorcontrib><creatorcontrib>Novelli, Viola</creatorcontrib><creatorcontrib>Marena, Carlo</creatorcontrib><title>“REAl LIfe” observational study on the effectiveness of Evusheld prophylaxis against SARS-CoV-2 omicron variants in vaccine non-responder immunocompromised patients (REALISE)</title><title>Vaccine</title><addtitle>Vaccine</addtitle><description>Background: Infection by SARS-CoV2 has become a challenge, especially for immunocompromised patients who show a weaker humoral response to COVID-19 vaccine. Tixagevimab+cilgavimab (Evusheld) is a combination of human monoclonal antibodies that can be used for pre-exposure prophylaxis to prevent infection or disease by SARS-CoV2. Objectives: Our study aimed to investigate the effectiveness of Evusheld by comparing an Exposed and an Unexposed group. Study design: Immunocompromised patients were enrolled in the Evusheld Group between March and September 2022. All patients had anti-spike IgG antibody levels <260 BAU/ml before administration of Evusheld. Blood samples for serological evaluations were collected, and anti-Spike antibodies were tested. For the Unexposed Group, a serologic test was performed at enrollment and a questionnaire was performed after 6 months. Results: 43 patients received Evusheld pre-exposure prophylaxis and 45 patients not receiving Evusheld were enrolled in the Unexposed group. The median age was 59.0 years in the Evusheld group, and 63.0 in the unexposed group. In the Evusheld group, during the Omicron wave in Italy, 23.3% of subjects developed symptomatic infection compared to 42.2% in the unexposed group. A majority of infections was seen in male respect to female patients. No difference in length of infection between the groups was seen. Antibody level remained higher than the basal threshold at 180 days from enrollment. Conclusions: Evusheld seems to reduce the rate of symptomatic infection in immunocompromised patients. Further data are required to determine whether this prophylaxis may have a longer-lasting effect over time.
•Immunocompromised patients: weaker humoral response to Sars-CoV-2 vaccine.•Human monoclonal antibodies for pre-exposure prophylaxis.•Difference Sars-CoV-2 infection rate between males and females•Likely effectiveness of tixagevimab+cilgavimab in reducing symptomatic infection rate in immunocompromised patients.</description><subject>Adult</subject><subject>Aged</subject><subject>Antibodies</subject><subject>Antibodies, Monoclonal, Humanized - immunology</subject><subject>Antibodies, Monoclonal, Humanized - therapeutic use</subject><subject>Antibodies, Viral - blood</subject><subject>Antibodies, Viral - immunology</subject><subject>COVID-19</subject><subject>COVID-19 - immunology</subject><subject>COVID-19 - prevention & control</subject><subject>COVID-19 vaccines</subject><subject>COVID-19 Vaccines - administration & dosage</subject><subject>COVID-19 Vaccines - immunology</subject><subject>Disease prevention</subject><subject>Effectiveness</subject><subject>Enrollments</subject><subject>Evusheld</subject><subject>Exposure</subject><subject>Female</subject><subject>Hematology</subject><subject>Humans</subject><subject>IgG antibody</subject><subject>Immune response (humoral)</subject><subject>Immune system</subject><subject>Immunity (Disease)</subject><subject>Immunocompromised Host</subject><subject>Immunocompromised hosts</subject><subject>Immunocompromised patients</subject><subject>Immunoglobulin G</subject><subject>Immunoglobulin G - blood</subject><subject>Infections</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Monoclonal antibodies</subject><subject>Observational studies</subject><subject>Patients</subject><subject>Pre-Exposure Prophylaxis - methods</subject><subject>Prophylaxis</subject><subject>Questionnaires</subject><subject>SARS-CoV-2 - immunology</subject><subject>Serology</subject><subject>Severe acute respiratory syndrome coronavirus 2</subject><subject>Spike Glycoprotein, Coronavirus - immunology</subject><subject>Transplants & implants</subject><subject>Vaccination</subject><subject>Vaccines</subject><subject>Viral diseases</subject><issn>0264-410X</issn><issn>1873-2518</issn><issn>1873-2518</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2024</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>8G5</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>GNUQQ</sourceid><sourceid>GUQSH</sourceid><sourceid>M2O</sourceid><recordid>eNqFkU-O0zAYxSMEYsrAEUCW2AyLFP9LGq9QVZWhUiWkKSB2luN8pq4Su9hJNN3NQZhLcKQ5CS4tLNiw8rf4veen97LsJcFTgkn5djcdldbWwZRiyqeElhRXj7IJqWYspwWpHmcTTEuec4K_XmTPYtxhjAtGxNPsgglS8IKwSfbz4e7HzXLeovXKwMPdPfJ1hDCq3nqnWhT7oTkg71C_BQTGgO7tCA5iRN6g5TjELbQN2ge_3x5adWsjUt-UdbFHm_nNJl_4LzlFvrM6JJNRBatcH5E93r_TI-ddHiDuvWsgINt1g_Pad8mxsxGSdYoCR81VirlebZZvnmdPjGojvDi_l9nn98tPiw_5-uP1ajFf55qRqs_BVKAwMGOoACEErivFocSsqhsKDWhdA6loLQohqhkphIJCK1wTjOtCm5pdZlcn35Tl-wCxlymRhrZVDvwQJcOC81LwiiX09T_ozg8hFZgoghmlvJzxRBUnKpURYwAj98F2KhwkwfI4qtzJcy3yOKo8jZp0r87uQ91B81f1Z8UEvDsBkOoYLQQZdSpNQ2NDWkw23v7ni1_bpbpq</recordid><startdate>20241003</startdate><enddate>20241003</enddate><creator>Esposito, Giuliana Lucia</creator><creator>Fassio, Federico</creator><creator>Girardi, Daniela</creator><creator>Picasso, Erica</creator><creator>Meloni, Federica</creator><creator>Montini, Simone</creator><creator>Codullo, Veronica</creator><creator>Pattonieri, Eleonora Francesca</creator><creator>Defrancesco, Irene</creator><creator>Bianchessi, Antonio</creator><creator>Calvi, Monica</creator><creator>Seminari, Elena Maria</creator><creator>Baldanti, Fausto</creator><creator>Lilleri, Daniele</creator><creator>Novelli, Viola</creator><creator>Marena, Carlo</creator><general>Elsevier Ltd</general><general>Elsevier Limited</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7QL</scope><scope>7RV</scope><scope>7T2</scope><scope>7T5</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88C</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8G5</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>GUQSH</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0R</scope><scope>M0S</scope><scope>M0T</scope><scope>M1P</scope><scope>M2O</scope><scope>M7N</scope><scope>M7P</scope><scope>MBDVC</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope></search><sort><creationdate>20241003</creationdate><title>“REAl LIfe” observational study on the effectiveness of Evusheld prophylaxis against SARS-CoV-2 omicron variants in vaccine non-responder immunocompromised patients (REALISE)</title><author>Esposito, Giuliana Lucia ; Fassio, Federico ; Girardi, Daniela ; Picasso, Erica ; Meloni, Federica ; Montini, Simone ; Codullo, Veronica ; Pattonieri, Eleonora Francesca ; Defrancesco, Irene ; Bianchessi, Antonio ; Calvi, Monica ; Seminari, Elena Maria ; Baldanti, Fausto ; Lilleri, Daniele ; Novelli, Viola ; Marena, Carlo</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c318t-ef8ea0e3ff29e9990b8a4e6038bd2edeccbe182b959987159ae5ca0b100b5cfb3</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2024</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Antibodies</topic><topic>Antibodies, Monoclonal, Humanized - immunology</topic><topic>Antibodies, Monoclonal, Humanized - therapeutic use</topic><topic>Antibodies, Viral - blood</topic><topic>Antibodies, Viral - immunology</topic><topic>COVID-19</topic><topic>COVID-19 - immunology</topic><topic>COVID-19 - prevention & control</topic><topic>COVID-19 vaccines</topic><topic>COVID-19 Vaccines - administration & dosage</topic><topic>COVID-19 Vaccines - immunology</topic><topic>Disease prevention</topic><topic>Effectiveness</topic><topic>Enrollments</topic><topic>Evusheld</topic><topic>Exposure</topic><topic>Female</topic><topic>Hematology</topic><topic>Humans</topic><topic>IgG antibody</topic><topic>Immune response (humoral)</topic><topic>Immune system</topic><topic>Immunity (Disease)</topic><topic>Immunocompromised Host</topic><topic>Immunocompromised hosts</topic><topic>Immunocompromised patients</topic><topic>Immunoglobulin G</topic><topic>Immunoglobulin G - blood</topic><topic>Infections</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Monoclonal antibodies</topic><topic>Observational studies</topic><topic>Patients</topic><topic>Pre-Exposure Prophylaxis - methods</topic><topic>Prophylaxis</topic><topic>Questionnaires</topic><topic>SARS-CoV-2 - immunology</topic><topic>Serology</topic><topic>Severe acute respiratory syndrome coronavirus 2</topic><topic>Spike Glycoprotein, Coronavirus - immunology</topic><topic>Transplants & implants</topic><topic>Vaccination</topic><topic>Vaccines</topic><topic>Viral diseases</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Esposito, Giuliana Lucia</creatorcontrib><creatorcontrib>Fassio, Federico</creatorcontrib><creatorcontrib>Girardi, Daniela</creatorcontrib><creatorcontrib>Picasso, Erica</creatorcontrib><creatorcontrib>Meloni, Federica</creatorcontrib><creatorcontrib>Montini, Simone</creatorcontrib><creatorcontrib>Codullo, Veronica</creatorcontrib><creatorcontrib>Pattonieri, Eleonora Francesca</creatorcontrib><creatorcontrib>Defrancesco, Irene</creatorcontrib><creatorcontrib>Bianchessi, Antonio</creatorcontrib><creatorcontrib>Calvi, Monica</creatorcontrib><creatorcontrib>Seminari, Elena Maria</creatorcontrib><creatorcontrib>Baldanti, Fausto</creatorcontrib><creatorcontrib>Lilleri, Daniele</creatorcontrib><creatorcontrib>Novelli, Viola</creatorcontrib><creatorcontrib>Marena, Carlo</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Bacteriology Abstracts (Microbiology B)</collection><collection>Nursing & Allied Health Database</collection><collection>Health and Safety Science Abstracts (Full archive)</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Healthcare Administration Database (Alumni)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Research Library (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>Research Library Prep</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>Consumer Health Database (Alumni Edition)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Healthcare Administration Database</collection><collection>Medical Database</collection><collection>Research Library</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Research Library (Corporate)</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><jtitle>Vaccine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Esposito, Giuliana Lucia</au><au>Fassio, Federico</au><au>Girardi, Daniela</au><au>Picasso, Erica</au><au>Meloni, Federica</au><au>Montini, Simone</au><au>Codullo, Veronica</au><au>Pattonieri, Eleonora Francesca</au><au>Defrancesco, Irene</au><au>Bianchessi, Antonio</au><au>Calvi, Monica</au><au>Seminari, Elena Maria</au><au>Baldanti, Fausto</au><au>Lilleri, Daniele</au><au>Novelli, Viola</au><au>Marena, Carlo</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>“REAl LIfe” observational study on the effectiveness of Evusheld prophylaxis against SARS-CoV-2 omicron variants in vaccine non-responder immunocompromised patients (REALISE)</atitle><jtitle>Vaccine</jtitle><addtitle>Vaccine</addtitle><date>2024-10-03</date><risdate>2024</risdate><volume>42</volume><issue>23</issue><spage>126208</spage><pages>126208-</pages><artnum>126208</artnum><issn>0264-410X</issn><issn>1873-2518</issn><eissn>1873-2518</eissn><abstract>Background: Infection by SARS-CoV2 has become a challenge, especially for immunocompromised patients who show a weaker humoral response to COVID-19 vaccine. Tixagevimab+cilgavimab (Evusheld) is a combination of human monoclonal antibodies that can be used for pre-exposure prophylaxis to prevent infection or disease by SARS-CoV2. Objectives: Our study aimed to investigate the effectiveness of Evusheld by comparing an Exposed and an Unexposed group. Study design: Immunocompromised patients were enrolled in the Evusheld Group between March and September 2022. All patients had anti-spike IgG antibody levels <260 BAU/ml before administration of Evusheld. Blood samples for serological evaluations were collected, and anti-Spike antibodies were tested. For the Unexposed Group, a serologic test was performed at enrollment and a questionnaire was performed after 6 months. Results: 43 patients received Evusheld pre-exposure prophylaxis and 45 patients not receiving Evusheld were enrolled in the Unexposed group. The median age was 59.0 years in the Evusheld group, and 63.0 in the unexposed group. In the Evusheld group, during the Omicron wave in Italy, 23.3% of subjects developed symptomatic infection compared to 42.2% in the unexposed group. A majority of infections was seen in male respect to female patients. No difference in length of infection between the groups was seen. Antibody level remained higher than the basal threshold at 180 days from enrollment. Conclusions: Evusheld seems to reduce the rate of symptomatic infection in immunocompromised patients. Further data are required to determine whether this prophylaxis may have a longer-lasting effect over time.
•Immunocompromised patients: weaker humoral response to Sars-CoV-2 vaccine.•Human monoclonal antibodies for pre-exposure prophylaxis.•Difference Sars-CoV-2 infection rate between males and females•Likely effectiveness of tixagevimab+cilgavimab in reducing symptomatic infection rate in immunocompromised patients.</abstract><cop>Netherlands</cop><pub>Elsevier Ltd</pub><pmid>39154513</pmid><doi>10.1016/j.vaccine.2024.126208</doi><oa>free_for_read</oa></addata></record> |
fulltext | fulltext |
identifier | ISSN: 0264-410X |
ispartof | Vaccine, 2024-10, Vol.42 (23), p.126208, Article 126208 |
issn | 0264-410X 1873-2518 1873-2518 |
language | eng |
recordid | cdi_proquest_miscellaneous_3094469483 |
source | MEDLINE; Elsevier ScienceDirect Journals Complete; ProQuest Central UK/Ireland |
subjects | Adult Aged Antibodies Antibodies, Monoclonal, Humanized - immunology Antibodies, Monoclonal, Humanized - therapeutic use Antibodies, Viral - blood Antibodies, Viral - immunology COVID-19 COVID-19 - immunology COVID-19 - prevention & control COVID-19 vaccines COVID-19 Vaccines - administration & dosage COVID-19 Vaccines - immunology Disease prevention Effectiveness Enrollments Evusheld Exposure Female Hematology Humans IgG antibody Immune response (humoral) Immune system Immunity (Disease) Immunocompromised Host Immunocompromised hosts Immunocompromised patients Immunoglobulin G Immunoglobulin G - blood Infections Male Middle Aged Monoclonal antibodies Observational studies Patients Pre-Exposure Prophylaxis - methods Prophylaxis Questionnaires SARS-CoV-2 - immunology Serology Severe acute respiratory syndrome coronavirus 2 Spike Glycoprotein, Coronavirus - immunology Transplants & implants Vaccination Vaccines Viral diseases |
title | “REAl LIfe” observational study on the effectiveness of Evusheld prophylaxis against SARS-CoV-2 omicron variants in vaccine non-responder immunocompromised patients (REALISE) |
url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-24T17%3A30%3A16IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-proquest_cross&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=%E2%80%9CREAl%20LIfe%E2%80%9D%20observational%20study%20on%20the%20effectiveness%20of%20Evusheld%20prophylaxis%20against%20SARS-CoV-2%20omicron%20variants%20in%20vaccine%20non-responder%20immunocompromised%20patients%20(REALISE)&rft.jtitle=Vaccine&rft.au=Esposito,%20Giuliana%20Lucia&rft.date=2024-10-03&rft.volume=42&rft.issue=23&rft.spage=126208&rft.pages=126208-&rft.artnum=126208&rft.issn=0264-410X&rft.eissn=1873-2518&rft_id=info:doi/10.1016/j.vaccine.2024.126208&rft_dat=%3Cproquest_cross%3E3103224674%3C/proquest_cross%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=3103224674&rft_id=info:pmid/39154513&rft_els_id=S0264410X24008909&rfr_iscdi=true |