“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...

Ausführliche Beschreibung

Gespeichert in:
Bibliographische Detailangaben
Veröffentlicht in:Vaccine 2024-10, Vol.42 (23), p.126208, Article 126208
Hauptverfasser: 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
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 &lt;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 &amp; control ; COVID-19 vaccines ; COVID-19 Vaccines - administration &amp; 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 &amp; 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 &lt;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 &amp; control</subject><subject>COVID-19 vaccines</subject><subject>COVID-19 Vaccines - administration &amp; 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 &amp; 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 &amp; control</topic><topic>COVID-19 vaccines</topic><topic>COVID-19 Vaccines - administration &amp; 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 &amp; 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 &amp; 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 &amp; 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 &amp; Medical Complete (Alumni)</collection><collection>Nursing &amp; Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Consumer Health Database</collection><collection>Health &amp; 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 &amp; 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 &lt;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