Immunogenicity and 1-year boostability of a three-dose intramuscular rabies pre-exposure prophylaxis schedule in adults receiving immunosuppressive monotherapy: a prospective single-centre clinical trial
Abstract Background For immunocompromised patients (ICPs), administration of rabies immunoglobulins (RIG) after exposure is still recommended regardless of prior vaccination, due to a lack of data. We aimed to assess the 1-year boostability of a three-dose rabies pre-exposure prophylaxis (PrEP) sche...
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| Veröffentlicht in: | Journal of travel medicine 2023-04, Vol.30 (2) |
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| creator | Garcia Garrido, Hannah M van Put, Bridget Terryn, Sanne de Pijper, Cornelis A Stijnis, Cornelis D’Haens, Geert R Spuls, Phyllis I van de Sande, Marleen G van Gucht, Steven Grobusch, Martin P Goorhuis, Abraham |
| description | Abstract
Background
For immunocompromised patients (ICPs), administration of rabies immunoglobulins (RIG) after exposure is still recommended regardless of prior vaccination, due to a lack of data. We aimed to assess the 1-year boostability of a three-dose rabies pre-exposure prophylaxis (PrEP) schedule in individuals using immunosuppressive monotherapy.
Methods
In this prospective study, individuals on immunosuppressive monotherapy with a conventional immunomodulator (cIM) or a TNF-alpha inhibitor (TNFi) for a chronic inflammatory disease received a three-dose intramuscular PrEP schedule (days 0,7,21–28) with 1 mL Rabipur®, followed by a two-dose simulated post-exposure prophylaxis (PEP) schedule (days 0,3) after 12 months. Rabies neutralizing antibodies were assessed at baseline, on day 21–28 (before the third PrEP dose), day 60, month 12 and month 12 + 7 days. The primary outcome was 1-year boostability, defined as the proportion of patients with a neutralizing antibody titre of ≥ 0.5 IU/mL at month 12 + 7 days. Secondary outcomes were geometric mean titres (GMTs) and factors associated with the primary endpoint.
Results
We included 56 individuals, of whom 52 completed the study. The 1-year boostability was 90% (47/52) with a GMT of 6.16 (95% CI 3.83–9.91). All participants seroconverted at some point in the study. Early response to PrEP (at day 21–28) was significantly associated with 100% boostability (Odds Ratio 51; 95% confidence interval [5.0–6956], P |
| doi_str_mv | 10.1093/jtm/taac148 |
| format | Article |
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Background
For immunocompromised patients (ICPs), administration of rabies immunoglobulins (RIG) after exposure is still recommended regardless of prior vaccination, due to a lack of data. We aimed to assess the 1-year boostability of a three-dose rabies pre-exposure prophylaxis (PrEP) schedule in individuals using immunosuppressive monotherapy.
Methods
In this prospective study, individuals on immunosuppressive monotherapy with a conventional immunomodulator (cIM) or a TNF-alpha inhibitor (TNFi) for a chronic inflammatory disease received a three-dose intramuscular PrEP schedule (days 0,7,21–28) with 1 mL Rabipur®, followed by a two-dose simulated post-exposure prophylaxis (PEP) schedule (days 0,3) after 12 months. Rabies neutralizing antibodies were assessed at baseline, on day 21–28 (before the third PrEP dose), day 60, month 12 and month 12 + 7 days. The primary outcome was 1-year boostability, defined as the proportion of patients with a neutralizing antibody titre of ≥ 0.5 IU/mL at month 12 + 7 days. Secondary outcomes were geometric mean titres (GMTs) and factors associated with the primary endpoint.
Results
We included 56 individuals, of whom 52 completed the study. The 1-year boostability was 90% (47/52) with a GMT of 6.16 (95% CI 3.83–9.91). All participants seroconverted at some point in the study. Early response to PrEP (at day 21–28) was significantly associated with 100% boostability (Odds Ratio 51; 95% confidence interval [5.0–6956], P < 0.01). The vaccination schedule was safe and well tolerated. No vaccine-related serious adverse events occurred.
Conclusion
In patients using immunosuppressive monotherapy, a three-dose rabies PrEP schedule followed by a two-dose PEP schedule is immunogenic, with all patients seroconverting at some point in the study. Although boostability 7 days after PEP was not 100%, nobody would wrongly be denied RIG when only administered to those who responded early to PrEP while reducing the administration of RIG by 73%.</description><identifier>ISSN: 1195-1982</identifier><identifier>EISSN: 1708-8305</identifier><identifier>DOI: 10.1093/jtm/taac148</identifier><identifier>PMID: 36477981</identifier><language>eng</language><publisher>England: Oxford University Press</publisher><subject>Adult ; Antibodies ; Antibodies, Neutralizing ; Antibodies, Viral ; Disease prevention ; Editor's Choice ; Exposure ; Humans ; Immunization ; Immunization Schedule ; Immunocompromised hosts ; Immunogenicity ; Immunoglobulins ; Immunomodulation ; Immunomodulators ; Immunosuppressive Agents ; Inflammatory diseases ; Neutralizing ; Original ; Post-Exposure Prophylaxis ; Pre-Exposure Prophylaxis ; Prophylaxis ; Prospective Studies ; Rabies ; Rabies - prevention & control ; Rabies Vaccines ; Schedules</subject><ispartof>Journal of travel medicine, 2023-04, Vol.30 (2)</ispartof><rights>International Society of Travel Medicine 2022. Published by Oxford University Press. 2022</rights><rights>International Society of Travel Medicine 2022. Published by Oxford University Press.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><cites>FETCH-LOGICAL-c399t-e487bec5f01a509b1a153f2025f6fe366d4628c110eb3e2f37548c2d85cd6b813</cites><orcidid>0000-0002-2244-9031 ; 0000-0002-5524-9984</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,778,782,883,1581,27911,27912</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/36477981$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Garcia Garrido, Hannah M</creatorcontrib><creatorcontrib>van Put, Bridget</creatorcontrib><creatorcontrib>Terryn, Sanne</creatorcontrib><creatorcontrib>de Pijper, Cornelis A</creatorcontrib><creatorcontrib>Stijnis, Cornelis</creatorcontrib><creatorcontrib>D’Haens, Geert R</creatorcontrib><creatorcontrib>Spuls, Phyllis I</creatorcontrib><creatorcontrib>van de Sande, Marleen G</creatorcontrib><creatorcontrib>van Gucht, Steven</creatorcontrib><creatorcontrib>Grobusch, Martin P</creatorcontrib><creatorcontrib>Goorhuis, Abraham</creatorcontrib><title>Immunogenicity and 1-year boostability of a three-dose intramuscular rabies pre-exposure prophylaxis schedule in adults receiving immunosuppressive monotherapy: a prospective single-centre clinical trial</title><title>Journal of travel medicine</title><addtitle>J Travel Med</addtitle><description>Abstract
Background
For immunocompromised patients (ICPs), administration of rabies immunoglobulins (RIG) after exposure is still recommended regardless of prior vaccination, due to a lack of data. We aimed to assess the 1-year boostability of a three-dose rabies pre-exposure prophylaxis (PrEP) schedule in individuals using immunosuppressive monotherapy.
Methods
In this prospective study, individuals on immunosuppressive monotherapy with a conventional immunomodulator (cIM) or a TNF-alpha inhibitor (TNFi) for a chronic inflammatory disease received a three-dose intramuscular PrEP schedule (days 0,7,21–28) with 1 mL Rabipur®, followed by a two-dose simulated post-exposure prophylaxis (PEP) schedule (days 0,3) after 12 months. Rabies neutralizing antibodies were assessed at baseline, on day 21–28 (before the third PrEP dose), day 60, month 12 and month 12 + 7 days. The primary outcome was 1-year boostability, defined as the proportion of patients with a neutralizing antibody titre of ≥ 0.5 IU/mL at month 12 + 7 days. Secondary outcomes were geometric mean titres (GMTs) and factors associated with the primary endpoint.
Results
We included 56 individuals, of whom 52 completed the study. The 1-year boostability was 90% (47/52) with a GMT of 6.16 (95% CI 3.83–9.91). All participants seroconverted at some point in the study. Early response to PrEP (at day 21–28) was significantly associated with 100% boostability (Odds Ratio 51; 95% confidence interval [5.0–6956], P < 0.01). The vaccination schedule was safe and well tolerated. No vaccine-related serious adverse events occurred.
Conclusion
In patients using immunosuppressive monotherapy, a three-dose rabies PrEP schedule followed by a two-dose PEP schedule is immunogenic, with all patients seroconverting at some point in the study. Although boostability 7 days after PEP was not 100%, nobody would wrongly be denied RIG when only administered to those who responded early to PrEP while reducing the administration of RIG by 73%.</description><subject>Adult</subject><subject>Antibodies</subject><subject>Antibodies, Neutralizing</subject><subject>Antibodies, Viral</subject><subject>Disease prevention</subject><subject>Editor's Choice</subject><subject>Exposure</subject><subject>Humans</subject><subject>Immunization</subject><subject>Immunization Schedule</subject><subject>Immunocompromised hosts</subject><subject>Immunogenicity</subject><subject>Immunoglobulins</subject><subject>Immunomodulation</subject><subject>Immunomodulators</subject><subject>Immunosuppressive Agents</subject><subject>Inflammatory diseases</subject><subject>Neutralizing</subject><subject>Original</subject><subject>Post-Exposure Prophylaxis</subject><subject>Pre-Exposure Prophylaxis</subject><subject>Prophylaxis</subject><subject>Prospective Studies</subject><subject>Rabies</subject><subject>Rabies - prevention & control</subject><subject>Rabies Vaccines</subject><subject>Schedules</subject><issn>1195-1982</issn><issn>1708-8305</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2023</creationdate><recordtype>article</recordtype><sourceid>TOX</sourceid><sourceid>EIF</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><recordid>eNp9kk2L1TAUhosozji6ci8BQQSpk4-mTd2IDH4MDLjRdUjT09tc0qbm4zL9jf4p07nXQV24yknynPe8JzlF8ZzgtwS37HIfp8uolCaVeFCckwaLUjDMH-aYtLwkraBnxZMQ9hhjKih9XJyxumqaVpDz4uf1NKXZ7WA22sQVqblHpFxBedQ5F6LqjN3O3YAUiqMHKHsXAJk5ejWloJPNqM8YBLR4KOF2cSF5yBu3jKtVtyagoEfok93SkMpBDMiDBnMw8w6ZOwchLTk9BHMANLnZxRG8WtZ3uWxWCgvouF2FnGGh1JDrA9LWZN_KouiNsk-LR4OyAZ6d1ovi-6eP366-lDdfP19ffbgpNWvbWEIlmg40HzBRHLcdUYSzgWLKh3oAVtd9VVOhCcHQMaADa3glNO0F133dCcIuivdH3SV1E_R3XpSVizeT8qt0ysi_b2Yzyp07SIJxwzFvssLrk4J3PxKEKCcTNFirZnApSNpwxkgtSJ3Rl_-ge5f8nPuT-ZOJaLHAG_XmSOn8VsHDcO-GYLlNicxTIk9TkukXfzZwz_4eiwy8OgIuLf9V-gXdkM5n</recordid><startdate>20230405</startdate><enddate>20230405</enddate><creator>Garcia Garrido, Hannah M</creator><creator>van Put, Bridget</creator><creator>Terryn, Sanne</creator><creator>de Pijper, Cornelis A</creator><creator>Stijnis, Cornelis</creator><creator>D’Haens, Geert R</creator><creator>Spuls, Phyllis I</creator><creator>van de Sande, Marleen G</creator><creator>van Gucht, Steven</creator><creator>Grobusch, Martin P</creator><creator>Goorhuis, Abraham</creator><general>Oxford University Press</general><scope>TOX</scope><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>7RV</scope><scope>7T5</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8C1</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8FQ</scope><scope>8FV</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>H94</scope><scope>K9.</scope><scope>KB0</scope><scope>M0S</scope><scope>M1P</scope><scope>M3G</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><orcidid>https://orcid.org/0000-0002-2244-9031</orcidid><orcidid>https://orcid.org/0000-0002-5524-9984</orcidid></search><sort><creationdate>20230405</creationdate><title>Immunogenicity and 1-year boostability of a three-dose intramuscular rabies pre-exposure prophylaxis schedule in adults receiving immunosuppressive monotherapy: a prospective single-centre clinical trial</title><author>Garcia Garrido, Hannah M ; van Put, Bridget ; Terryn, Sanne ; de Pijper, Cornelis A ; Stijnis, Cornelis ; D’Haens, Geert R ; Spuls, Phyllis I ; van de Sande, Marleen G ; van Gucht, Steven ; Grobusch, Martin P ; Goorhuis, Abraham</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c399t-e487bec5f01a509b1a153f2025f6fe366d4628c110eb3e2f37548c2d85cd6b813</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2023</creationdate><topic>Adult</topic><topic>Antibodies</topic><topic>Antibodies, Neutralizing</topic><topic>Antibodies, Viral</topic><topic>Disease prevention</topic><topic>Editor's Choice</topic><topic>Exposure</topic><topic>Humans</topic><topic>Immunization</topic><topic>Immunization Schedule</topic><topic>Immunocompromised hosts</topic><topic>Immunogenicity</topic><topic>Immunoglobulins</topic><topic>Immunomodulation</topic><topic>Immunomodulators</topic><topic>Immunosuppressive Agents</topic><topic>Inflammatory diseases</topic><topic>Neutralizing</topic><topic>Original</topic><topic>Post-Exposure Prophylaxis</topic><topic>Pre-Exposure Prophylaxis</topic><topic>Prophylaxis</topic><topic>Prospective Studies</topic><topic>Rabies</topic><topic>Rabies - prevention & control</topic><topic>Rabies Vaccines</topic><topic>Schedules</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Garcia Garrido, Hannah M</creatorcontrib><creatorcontrib>van Put, Bridget</creatorcontrib><creatorcontrib>Terryn, Sanne</creatorcontrib><creatorcontrib>de Pijper, Cornelis A</creatorcontrib><creatorcontrib>Stijnis, Cornelis</creatorcontrib><creatorcontrib>D’Haens, Geert R</creatorcontrib><creatorcontrib>Spuls, Phyllis I</creatorcontrib><creatorcontrib>van de Sande, Marleen G</creatorcontrib><creatorcontrib>van Gucht, Steven</creatorcontrib><creatorcontrib>Grobusch, Martin P</creatorcontrib><creatorcontrib>Goorhuis, Abraham</creatorcontrib><collection>Oxford Journals Open Access Collection</collection><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>Nursing & Allied Health Database</collection><collection>Immunology Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>Public Health Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Canadian Business & Current Affairs Database</collection><collection>Canadian Business & Current Affairs Database (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central</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>AIDS and Cancer Research Abstracts</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>CBCA Reference & Current Events</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><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of travel medicine</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Garcia Garrido, Hannah M</au><au>van Put, Bridget</au><au>Terryn, Sanne</au><au>de Pijper, Cornelis A</au><au>Stijnis, Cornelis</au><au>D’Haens, Geert R</au><au>Spuls, Phyllis I</au><au>van de Sande, Marleen G</au><au>van Gucht, Steven</au><au>Grobusch, Martin P</au><au>Goorhuis, Abraham</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Immunogenicity and 1-year boostability of a three-dose intramuscular rabies pre-exposure prophylaxis schedule in adults receiving immunosuppressive monotherapy: a prospective single-centre clinical trial</atitle><jtitle>Journal of travel medicine</jtitle><addtitle>J Travel Med</addtitle><date>2023-04-05</date><risdate>2023</risdate><volume>30</volume><issue>2</issue><issn>1195-1982</issn><eissn>1708-8305</eissn><abstract>Abstract
Background
For immunocompromised patients (ICPs), administration of rabies immunoglobulins (RIG) after exposure is still recommended regardless of prior vaccination, due to a lack of data. We aimed to assess the 1-year boostability of a three-dose rabies pre-exposure prophylaxis (PrEP) schedule in individuals using immunosuppressive monotherapy.
Methods
In this prospective study, individuals on immunosuppressive monotherapy with a conventional immunomodulator (cIM) or a TNF-alpha inhibitor (TNFi) for a chronic inflammatory disease received a three-dose intramuscular PrEP schedule (days 0,7,21–28) with 1 mL Rabipur®, followed by a two-dose simulated post-exposure prophylaxis (PEP) schedule (days 0,3) after 12 months. Rabies neutralizing antibodies were assessed at baseline, on day 21–28 (before the third PrEP dose), day 60, month 12 and month 12 + 7 days. The primary outcome was 1-year boostability, defined as the proportion of patients with a neutralizing antibody titre of ≥ 0.5 IU/mL at month 12 + 7 days. Secondary outcomes were geometric mean titres (GMTs) and factors associated with the primary endpoint.
Results
We included 56 individuals, of whom 52 completed the study. The 1-year boostability was 90% (47/52) with a GMT of 6.16 (95% CI 3.83–9.91). All participants seroconverted at some point in the study. Early response to PrEP (at day 21–28) was significantly associated with 100% boostability (Odds Ratio 51; 95% confidence interval [5.0–6956], P < 0.01). The vaccination schedule was safe and well tolerated. No vaccine-related serious adverse events occurred.
Conclusion
In patients using immunosuppressive monotherapy, a three-dose rabies PrEP schedule followed by a two-dose PEP schedule is immunogenic, with all patients seroconverting at some point in the study. Although boostability 7 days after PEP was not 100%, nobody would wrongly be denied RIG when only administered to those who responded early to PrEP while reducing the administration of RIG by 73%.</abstract><cop>England</cop><pub>Oxford University Press</pub><pmid>36477981</pmid><doi>10.1093/jtm/taac148</doi><orcidid>https://orcid.org/0000-0002-2244-9031</orcidid><orcidid>https://orcid.org/0000-0002-5524-9984</orcidid><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of travel medicine, 2023-04, Vol.30 (2) |
| issn | 1195-1982 1708-8305 |
| language | eng |
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| source | MEDLINE; Oxford University Press Journals All Titles (1996-Current); Alma/SFX Local Collection |
| subjects | Adult Antibodies Antibodies, Neutralizing Antibodies, Viral Disease prevention Editor's Choice Exposure Humans Immunization Immunization Schedule Immunocompromised hosts Immunogenicity Immunoglobulins Immunomodulation Immunomodulators Immunosuppressive Agents Inflammatory diseases Neutralizing Original Post-Exposure Prophylaxis Pre-Exposure Prophylaxis Prophylaxis Prospective Studies Rabies Rabies - prevention & control Rabies Vaccines Schedules |
| title | Immunogenicity and 1-year boostability of a three-dose intramuscular rabies pre-exposure prophylaxis schedule in adults receiving immunosuppressive monotherapy: a prospective single-centre clinical trial |
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