Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial.
Identifieur interne : 000226 ( Main/Exploration ); précédent : 000225; suivant : 000227Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial.
Auteurs : Juliana Martinez-Atienza [Espagne] ; Clara Rosso-Fernández ; Cristina Roca ; Teresa A. Aydillo ; Joan Gavaldà ; Asunci N Moreno ; Jose M. Montejo ; Julian Torre-Cisneros ; M Carmen Fari As ; Jesus Fortun ; Nuria Sabé ; Patricia Mu Oz ; Marino Blanes-Julia ; Alejandro Suárez-Benjumea ; Francisco L Pez-Medrano ; Pilar Pérez-Romero ; Elisa CorderoSource :
- Trials [ 1745-6215 ] ; 2014.
Descripteurs français
- KwdFr :
- Anticorps antiviraux (sang), Anticorps neutralisants (sang), Espagne (MeSH), Facteurs temps (MeSH), Grippe humaine (diagnostic), Grippe humaine (immunologie), Grippe humaine (mortalité), Grippe humaine (prévention et contrôle), Grippe humaine (virologie), Humains (MeSH), Hôpitaux publics (MeSH), Marqueurs biologiques (sang), Orthomyxoviridae (immunologie), Plan de recherche (MeSH), Protocoles cliniques (MeSH), Rappel de vaccin (MeSH), Rejet du greffon (immunologie), Rejet du greffon (prévention et contrôle), Rejet du greffon (virologie), Résultat thérapeutique (MeSH), Survie du greffon (MeSH), Transplantation d'organe (effets indésirables), Transplantation d'organe (mortalité), Vaccins antigrippaux (administration et posologie), Vaccins antigrippaux (effets indésirables).
- MESH :
- administration et posologie : Vaccins antigrippaux.
- diagnostic : Grippe humaine.
- effets indésirables : Transplantation d'organe, Vaccins antigrippaux.
- immunologie : Grippe humaine, Orthomyxoviridae, Rejet du greffon.
- mortalité : Grippe humaine, Transplantation d'organe.
- prévention et contrôle : Grippe humaine, Rejet du greffon.
- sang : Anticorps antiviraux, Anticorps neutralisants, Marqueurs biologiques.
- virologie : Grippe humaine, Rejet du greffon.
- Espagne, Facteurs temps, Humains, Hôpitaux publics, Plan de recherche, Protocoles cliniques, Rappel de vaccin, Résultat thérapeutique, Survie du greffon.
- Wicri :
- geographic : Espagne.
English descriptors
- KwdEn :
- Antibodies, Neutralizing (blood), Antibodies, Viral (blood), Biomarkers (blood), Clinical Protocols (MeSH), Graft Rejection (immunology), Graft Rejection (prevention & control), Graft Rejection (virology), Graft Survival (MeSH), Hospitals, Public (MeSH), Humans (MeSH), Immunization, Secondary (MeSH), Influenza Vaccines (administration & dosage), Influenza Vaccines (adverse effects), Influenza, Human (diagnosis), Influenza, Human (immunology), Influenza, Human (mortality), Influenza, Human (prevention & control), Influenza, Human (virology), Organ Transplantation (adverse effects), Organ Transplantation (mortality), Orthomyxoviridae (immunology), Research Design (MeSH), Spain (MeSH), Time Factors (MeSH), Treatment Outcome (MeSH).
- MESH :
- chemical , administration & dosage : Influenza Vaccines.
- chemical , adverse effects : Influenza Vaccines.
- chemical , blood : Antibodies, Neutralizing, Antibodies, Viral, Biomarkers.
- geographic : Spain.
- adverse effects : Organ Transplantation.
- diagnosis : Influenza, Human.
- immunology : Graft Rejection, Influenza, Human, Orthomyxoviridae.
- mortality : Influenza, Human, Organ Transplantation.
- prevention & control : Graft Rejection, Influenza, Human.
- virology : Graft Rejection, Influenza, Human.
- Clinical Protocols, Graft Survival, Hospitals, Public, Humans, Immunization, Secondary, Research Design, Time Factors, Treatment Outcome.
Abstract
BACKGROUND
Despite administration of annual influenza vaccination, influenza-associated complications in transplant recipients continue to be an important cause of hospitalization and death. Although influenza vaccination has been proven to be the most effective measure to reduce influenza infection after transplantation, transplant recipients are still vulnerable to influenza infections, with lower serological responses to vaccination compared to the general population. In order to assess the efficacy and safety of an alternative immunization scheme for solid organ transplant recipients, the TRANSGRIPE1-2 Study Group aimed to test a booster dose administration 5 weeks after the standard vaccination. The primary objective of this trial was to compare short-term and long-term neutralizing antibody immunogenicity of a booster dose of influenza vaccination to the standard single-dose immunization scheme. Secondary objectives included the evaluation of the efficacy and/or safety, cellular immune response, incidence of influenza infection, graft rejection, retransplant and mortality rates.
METHODS/DESIGN
This phase III, randomized, controlled, open-label clinical trial was conducted between October 2012 and December 2013 in 12 Spanish public referral hospitals. Solid organ transplant recipients (liver, kidney, heart or lung), older than 16 years of age more than 30 days after transplantation were eligible to participate. Patients (N = 514) were stratified 1:1 by center, type of organ and time after transplantation and who either received the standard single dose (n = 257) or were treated according to a novel influenza vaccination schedule comprising the administration of a booster dose 5 weeks after standard vaccination (n = 254). Seroconversion rates were measured as a determinant of protection against influenza (main outcome). Efficacy and safety outcomes were followed until 1 year after influenza vaccination with assessment of short-term (0, 5, 10 and 15 weeks) and long-term (12 months) results. Intention-to-treat, per-protocol and safety analyses will be performed.
DISCUSSION
This trial will increase knowledge about the safety and efficacy of a booster dose of influenza vaccine in solid organ transplant recipients. At the time the manuscript was submitted for publication, trial recruitment was closed with a total of 499 participants included during a 2-month period (within the seasonal influenza vaccination campaign).
TRIAL REGISTRATION
ClinicalTrials.gov Identifier: NCT01761435 (registered 13 December 2012). EudraCT Identifier: 2011-003243-21 (registered 4 July 2011).
DOI: 10.1186/1745-6215-15-338
PubMed: 25168918
PubMed Central: PMC4159520
Affiliations:
Links toward previous steps (curation, corpus...)
Le document en format XML
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Protocols (MeSH)</term><term>Graft Rejection (immunology)</term><term>Graft Rejection (prevention & control)</term><term>Graft Rejection (virology)</term><term>Graft Survival (MeSH)</term><term>Hospitals, Public (MeSH)</term><term>Humans (MeSH)</term><term>Immunization, Secondary (MeSH)</term><term>Influenza Vaccines (administration & dosage)</term><term>Influenza Vaccines (adverse effects)</term><term>Influenza, Human (diagnosis)</term><term>Influenza, Human (immunology)</term><term>Influenza, Human (mortality)</term><term>Influenza, Human (prevention & control)</term><term>Influenza, Human (virology)</term><term>Organ Transplantation (adverse effects)</term><term>Organ Transplantation (mortality)</term><term>Orthomyxoviridae (immunology)</term><term>Research Design (MeSH)</term><term>Spain (MeSH)</term><term>Time Factors (MeSH)</term><term>Treatment Outcome (MeSH)</term></keywords><keywords scheme="KwdFr" xml:lang="fr"><term>Anticorps antiviraux (sang)</term><term>Anticorps neutralisants (sang)</term><term>Espagne (MeSH)</term><term>Facteurs temps (MeSH)</term><term>Grippe humaine (diagnostic)</term><term>Grippe humaine (immunologie)</term><term>Grippe humaine (mortalité)</term><term>Grippe humaine (prévention et contrôle)</term><term>Grippe humaine (virologie)</term><term>Humains (MeSH)</term><term>Hôpitaux publics (MeSH)</term><term>Marqueurs biologiques (sang)</term><term>Orthomyxoviridae (immunologie)</term><term>Plan de recherche (MeSH)</term><term>Protocoles cliniques (MeSH)</term><term>Rappel de vaccin (MeSH)</term><term>Rejet du greffon (immunologie)</term><term>Rejet du greffon (prévention et contrôle)</term><term>Rejet du greffon (virologie)</term><term>Résultat thérapeutique (MeSH)</term><term>Survie du greffon (MeSH)</term><term>Transplantation d'organe (effets indésirables)</term><term>Transplantation d'organe (mortalité)</term><term>Vaccins antigrippaux (administration et posologie)</term><term>Vaccins antigrippaux (effets indésirables)</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Influenza Vaccines</term></keywords><keywords scheme="MESH" type="chemical" qualifier="blood" xml:lang="en"><term>Antibodies, Neutralizing</term><term>Antibodies, Viral</term><term>Biomarkers</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>Spain</term></keywords><keywords scheme="MESH" qualifier="administration et posologie" xml:lang="fr"><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="adverse effects" xml:lang="en"><term>Organ Transplantation</term></keywords><keywords scheme="MESH" qualifier="diagnosis" xml:lang="en"><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="diagnostic" xml:lang="fr"><term>Grippe humaine</term></keywords><keywords scheme="MESH" qualifier="effets indésirables" xml:lang="fr"><term>Transplantation d'organe</term><term>Vaccins antigrippaux</term></keywords><keywords scheme="MESH" qualifier="immunologie" xml:lang="fr"><term>Grippe humaine</term><term>Orthomyxoviridae</term><term>Rejet du greffon</term></keywords><keywords scheme="MESH" qualifier="immunology" xml:lang="en"><term>Graft Rejection</term><term>Influenza, Human</term><term>Orthomyxoviridae</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Influenza, Human</term><term>Organ Transplantation</term></keywords><keywords scheme="MESH" qualifier="mortalité" xml:lang="fr"><term>Grippe humaine</term><term>Transplantation d'organe</term></keywords><keywords scheme="MESH" qualifier="prevention & control" xml:lang="en"><term>Graft Rejection</term><term>Influenza, Human</term></keywords><keywords scheme="MESH" qualifier="prévention et contrôle" xml:lang="fr"><term>Grippe humaine</term><term>Rejet du greffon</term></keywords><keywords scheme="MESH" qualifier="sang" xml:lang="fr"><term>Anticorps antiviraux</term><term>Anticorps neutralisants</term><term>Marqueurs biologiques</term></keywords><keywords scheme="MESH" qualifier="virologie" xml:lang="fr"><term>Grippe humaine</term><term>Rejet du greffon</term></keywords><keywords scheme="MESH" qualifier="virology" xml:lang="en"><term>Graft Rejection</term><term>Influenza, Human</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Clinical Protocols</term><term>Graft Survival</term><term>Hospitals, Public</term><term>Humans</term><term>Immunization, Secondary</term><term>Research Design</term><term>Time Factors</term><term>Treatment Outcome</term></keywords><keywords scheme="MESH" xml:lang="fr"><term>Espagne</term><term>Facteurs temps</term><term>Humains</term><term>Hôpitaux publics</term><term>Plan de recherche</term><term>Protocoles cliniques</term><term>Rappel de vaccin</term><term>Résultat thérapeutique</term><term>Survie du greffon</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>Espagne</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p><b>BACKGROUND</b></p><p>Despite administration of annual influenza vaccination, influenza-associated complications in transplant recipients continue to be an important cause of hospitalization and death. Although influenza vaccination has been proven to be the most effective measure to reduce influenza infection after transplantation, transplant recipients are still vulnerable to influenza infections, with lower serological responses to vaccination compared to the general population. In order to assess the efficacy and safety of an alternative immunization scheme for solid organ transplant recipients, the TRANSGRIPE1-2 Study Group aimed to test a booster dose administration 5 weeks after the standard vaccination. The primary objective of this trial was to compare short-term and long-term neutralizing antibody immunogenicity of a booster dose of influenza vaccination to the standard single-dose immunization scheme. Secondary objectives included the evaluation of the efficacy and/or safety, cellular immune response, incidence of influenza infection, graft rejection, retransplant and mortality rates.</p></div><div type="abstract" xml:lang="en"><p><b>METHODS/DESIGN</b></p><p>This phase III, randomized, controlled, open-label clinical trial was conducted between October 2012 and December 2013 in 12 Spanish public referral hospitals. Solid organ transplant recipients (liver, kidney, heart or lung), older than 16 years of age more than 30 days after transplantation were eligible to participate. Patients (N = 514) were stratified 1:1 by center, type of organ and time after transplantation and who either received the standard single dose (n = 257) or were treated according to a novel influenza vaccination schedule comprising the administration of a booster dose 5 weeks after standard vaccination (n = 254). Seroconversion rates were measured as a determinant of protection against influenza (main outcome). Efficacy and safety outcomes were followed until 1 year after influenza vaccination with assessment of short-term (0, 5, 10 and 15 weeks) and long-term (12 months) results. Intention-to-treat, per-protocol and safety analyses will be performed.</p></div><div type="abstract" xml:lang="en"><p><b>DISCUSSION</b></p><p>This trial will increase knowledge about the safety and efficacy of a booster dose of influenza vaccine in solid organ transplant recipients. At the time the manuscript was submitted for publication, trial recruitment was closed with a total of 499 participants included during a 2-month period (within the seasonal influenza vaccination campaign).</p></div><div type="abstract" xml:lang="en"><p><b>TRIAL REGISTRATION</b></p><p>ClinicalTrials.gov Identifier: NCT01761435 (registered 13 December 2012). EudraCT Identifier: 2011-003243-21 (registered 4 July 2011).</p></div></front></TEI><pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">25168918</PMID><DateCompleted><Year>2015</Year><Month>05</Month><Day>28</Day></DateCompleted><DateRevised><Year>2018</Year><Month>11</Month><Day>13</Day></DateRevised><Article PubModel="Electronic"><Journal><ISSN IssnType="Electronic">1745-6215</ISSN><JournalIssue CitedMedium="Internet"><Volume>15</Volume><PubDate><Year>2014</Year><Month>Aug</Month><Day>28</Day></PubDate></JournalIssue><Title>Trials</Title><ISOAbbreviation>Trials</ISOAbbreviation></Journal><ArticleTitle>Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial.</ArticleTitle><Pagination><MedlinePgn>338</MedlinePgn></Pagination><ELocationID EIdType="doi" ValidYN="Y">10.1186/1745-6215-15-338</ELocationID><Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Despite administration of annual influenza vaccination, influenza-associated complications in transplant recipients continue to be an important cause of hospitalization and death. Although influenza vaccination has been proven to be the most effective measure to reduce influenza infection after transplantation, transplant recipients are still vulnerable to influenza infections, with lower serological responses to vaccination compared to the general population. In order to assess the efficacy and safety of an alternative immunization scheme for solid organ transplant recipients, the TRANSGRIPE1-2 Study Group aimed to test a booster dose administration 5 weeks after the standard vaccination. The primary objective of this trial was to compare short-term and long-term neutralizing antibody immunogenicity of a booster dose of influenza vaccination to the standard single-dose immunization scheme. Secondary objectives included the evaluation of the efficacy and/or safety, cellular immune response, incidence of influenza infection, graft rejection, retransplant and mortality rates.</AbstractText><AbstractText Label="METHODS/DESIGN" NlmCategory="METHODS">This phase III, randomized, controlled, open-label clinical trial was conducted between October 2012 and December 2013 in 12 Spanish public referral hospitals. Solid organ transplant recipients (liver, kidney, heart or lung), older than 16 years of age more than 30 days after transplantation were eligible to participate. Patients (N = 514) were stratified 1:1 by center, type of organ and time after transplantation and who either received the standard single dose (n = 257) or were treated according to a novel influenza vaccination schedule comprising the administration of a booster dose 5 weeks after standard vaccination (n = 254). Seroconversion rates were measured as a determinant of protection against influenza (main outcome). Efficacy and safety outcomes were followed until 1 year after influenza vaccination with assessment of short-term (0, 5, 10 and 15 weeks) and long-term (12 months) results. Intention-to-treat, per-protocol and safety analyses will be performed.</AbstractText><AbstractText Label="DISCUSSION" NlmCategory="CONCLUSIONS">This trial will increase knowledge about the safety and efficacy of a booster dose of influenza vaccine in solid organ transplant recipients. At the time the manuscript was submitted for publication, trial recruitment was closed with a total of 499 participants included during a 2-month period (within the seasonal influenza vaccination campaign).</AbstractText><AbstractText Label="TRIAL REGISTRATION" NlmCategory="BACKGROUND">ClinicalTrials.gov Identifier: NCT01761435 (registered 13 December 2012). EudraCT Identifier: 2011-003243-21 (registered 4 July 2011).</AbstractText></Abstract><AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Martinez-Atienza</LastName><ForeName>Juliana</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>Hospital Universitario Virgen del Rocío and Biomedicine Research Institute (IBIS), Infectious Diseases Research Group, Avda, Manuel Siurot, s/n, 41013 Seville, Spain. jumarati@gmail.com.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Rosso-Fernández</LastName><ForeName>Clara</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Roca</LastName><ForeName>Cristina</ForeName><Initials>C</Initials></Author><Author ValidYN="Y"><LastName>Aydillo</LastName><ForeName>Teresa A</ForeName><Initials>TA</Initials></Author><Author ValidYN="Y"><LastName>Gavaldà</LastName><ForeName>Joan</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Moreno</LastName><ForeName>Asunción</ForeName><Initials>A</Initials></Author><Author ValidYN="Y"><LastName>Montejo</LastName><ForeName>Jose M</ForeName><Initials>JM</Initials></Author><Author ValidYN="Y"><LastName>Torre-Cisneros</LastName><ForeName>Julian</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Fariñas</LastName><ForeName>M Carmen</ForeName><Initials>MC</Initials></Author><Author ValidYN="Y"><LastName>Fortun</LastName><ForeName>Jesus</ForeName><Initials>J</Initials></Author><Author ValidYN="Y"><LastName>Sabé</LastName><ForeName>Nuria</ForeName><Initials>N</Initials></Author><Author ValidYN="Y"><LastName>Muñoz</LastName><ForeName>Patricia</ForeName><Initials>P</Initials></Author><Author ValidYN="Y"><LastName>Blanes-Julia</LastName><ForeName>Marino</ForeName><Initials>M</Initials></Author><Author ValidYN="Y"><LastName>Suárez-Benjumea</LastName><ForeName>Alejandro</ForeName><Initials>A</Initials></Author><Author 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Aydillo</name><name sortKey="Blanes Julia, Marino" sort="Blanes Julia, Marino" uniqKey="Blanes Julia M" first="Marino" last="Blanes-Julia">Marino Blanes-Julia</name><name sortKey="Cordero, Elisa" sort="Cordero, Elisa" uniqKey="Cordero E" first="Elisa" last="Cordero">Elisa Cordero</name><name sortKey="Fari As, M Carmen" sort="Fari As, M Carmen" uniqKey="Fari As M" first="M Carmen" last="Fari As">M Carmen Fari As</name><name sortKey="Fortun, Jesus" sort="Fortun, Jesus" uniqKey="Fortun J" first="Jesus" last="Fortun">Jesus Fortun</name><name sortKey="Gavalda, Joan" sort="Gavalda, Joan" uniqKey="Gavalda J" first="Joan" last="Gavaldà">Joan Gavaldà</name><name sortKey="L Pez Medrano, Francisco" sort="L Pez Medrano, Francisco" uniqKey="L Pez Medrano F" first="Francisco" last="L Pez-Medrano">Francisco L Pez-Medrano</name><name sortKey="Montejo, Jose M" sort="Montejo, Jose M" uniqKey="Montejo J" first="Jose M" last="Montejo">Jose M. Montejo</name><name sortKey="Moreno, Asunci N" sort="Moreno, Asunci N" uniqKey="Moreno A" first="Asunci N" last="Moreno">Asunci N Moreno</name><name sortKey="Mu Oz, Patricia" sort="Mu Oz, Patricia" uniqKey="Mu Oz P" first="Patricia" last="Mu Oz">Patricia Mu Oz</name><name sortKey="Perez Romero, Pilar" sort="Perez Romero, Pilar" uniqKey="Perez Romero P" first="Pilar" last="Pérez-Romero">Pilar Pérez-Romero</name><name sortKey="Roca, Cristina" sort="Roca, Cristina" uniqKey="Roca C" first="Cristina" last="Roca">Cristina Roca</name><name sortKey="Rosso Fernandez, Clara" sort="Rosso Fernandez, Clara" uniqKey="Rosso Fernandez C" first="Clara" last="Rosso-Fernández">Clara Rosso-Fernández</name><name sortKey="Sabe, Nuria" sort="Sabe, Nuria" uniqKey="Sabe N" first="Nuria" last="Sabé">Nuria Sabé</name><name sortKey="Suarez Benjumea, Alejandro" sort="Suarez Benjumea, Alejandro" uniqKey="Suarez Benjumea A" first="Alejandro" last="Suárez-Benjumea">Alejandro Suárez-Benjumea</name><name sortKey="Torre Cisneros, Julian" sort="Torre Cisneros, Julian" uniqKey="Torre Cisneros J" first="Julian" last="Torre-Cisneros">Julian Torre-Cisneros</name></noCountry><country name="Espagne"><region name="Andalousie"><name sortKey="Martinez Atienza, Juliana" sort="Martinez Atienza, Juliana" uniqKey="Martinez Atienza J" first="Juliana" last="Martinez-Atienza">Juliana Martinez-Atienza</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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