Please use this identifier to cite or link to this item: http://hdl.handle.net/10668/2743
Título : 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.
Autor : Martinez-Atienza, Juliana
Rosso-Fernández, Clara
Roca, Cristina
Aydillo, Teresa A
Gavaldà, Joan
Moreno, Asunción
Montejo, Jose M
Torre-Cisneros, Julian
Fariñas, M Carmen
Fortun, Jesus
Sabé, Nuria
Muñoz, Patricia
Blanes-Julia, Marino
Suárez-Benjumea, Alejandro
López-Medrano, Francisco
Pérez-Romero, Pilar
Cordero, Elisa
Filiación: [Martinez-Atienza,J; Roca,C; Aydillo,TA; Pérez-Romero,P; Cordero,E] Hospital Universitario Virgen del Rocío and Biomedicine Research Institute (IBIS), Infectious Diseases Research Group, Seville, Spain. [Martinez-Atienza,J; Rosso-Fernández,C] Hospital Universitario Virgen del Rocío, Clinical Trial Unit, Seville, Spain. [Gavaldà,J] Hospital Vall d’Hebron, Infectious Diseases Research Group, Barcelona, Spain. [Moreno,A] Hospital Clinic, Infectious Diseases Research Group, Barcelona, Spain. [Montejo,JM] Hospital Universitario de Cruces, Infectious Diseases Research Group, Vizcaya, Spain.[Torre-Cisneros,J] Hospital Universitario Reina Sofía, Infectious Diseases Research Group, Cordoba, Spain. [Fariñas,MC] Hospital Universitario Marqués de Valdecilla, Infectious Diseases Research Group, Santander, Cantabria, Spain. [Fortun,J] Hospital Universitario Ramón y Cajal, Madrid, Spain. [Sabé,N] Hospital Universitario de Bellvitge, Infectious Diseases Research Group, L'Hospitalet de Llobregat, Barcelona, Spain.[Muñoz,P] Hospital General Universitario Gregorio Marañón, Infectious Diseases Research Group, Madrid, Spain. [Blanes-Julia,M] Hospital Universitario La Fe, Infectious Diseases Research Group, Valencia, Spain. [Suárez-Benjumea,A] Hospital Universitario Virgen Macarena, Infectious Diseases Research Group, Sevilla. [López-Medrano,F] Hospital Universitario 12 de Octubre, Infectious Diseases Research Group, Madrid, Spain.
Grupo de Investigación: TRANSGRIPE 1-2 Study Group
Palabras clave : Influenza prevention
Influenza vaccination
Randomized trial
Solid organ transplant
Ensayos clínicos controlados aleatorios como asunto
Protocolos clínicos
Vacunas contra la Influenza
Trasplantes
MeSH: Medical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Viral
Medical Subject Headings::Chemicals and Drugs::Biological Factors::Biological Markers
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Clinical Protocols
Medical Subject Headings::Phenomena and Processes::Immune System Phenomena::Immune System Processes::Transplantation Immunology::Host vs Graft Reaction::Graft Rejection
Medical Subject Headings::Phenomena and Processes::Immune System Phenomena::Immune System Processes::Transplantation Immunology::Host vs Graft Reaction::Graft Survival
Medical Subject Headings::Health Care::Health Care Facilities, Manpower, and Services::Health Facilities::Hospitals::Hospitals, Public
Medical Subject Headings::Organisms::Eukaryota::Animals::Chordata::Vertebrates::Mammals::Primates::Haplorhini::Catarrhini::Hominidae::Humans
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Therapeutics::Biological Therapy::Immunomodulation::Immunotherapy::Immunization::Immunization, Secondary
Medical Subject Headings::Chemicals and Drugs::Complex Mixtures::Biological Agents::Vaccines::Viral Vaccines::Influenza Vaccines
Medical Subject Headings::Diseases::Virus Diseases::RNA Virus Infections::Orthomyxoviridae Infections::Influenza, Human
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Surgical Procedures, Operative::Transplantation::Organ Transplantation
Medical Subject Headings::Organisms::Viruses::RNA Viruses::Orthomyxoviridae
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Investigative Techniques::Epidemiologic Methods::Epidemiologic Research Design
Medical Subject Headings::Geographicals::Geographic Locations::Europe::Spain
Medical Subject Headings::Phenomena and Processes::Physical Phenomena::Time::Time Factors
Medical Subject Headings::Analytical, Diagnostic and Therapeutic Techniques and Equipment::Diagnosis::Prognosis::Treatment Outcome
Medical Subject Headings::Chemicals and Drugs::Amino Acids, Peptides, and Proteins::Proteins::Blood Proteins::Immunoproteins::Immunoglobulins::Antibodies::Antibodies, Neutralizing
Fecha de publicación : 28-Aug-2014
Editorial : BioMed Central
Cita Bibliográfica: Martinez-Atienza J, Rosso-Fernández C, Roca C, Aydillo TA, Gavaldà J, Moreno A, et al. 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. Trials. 2014; 15:338
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).
Descripción : TRIAL REGISTRATION ClinicalTrials.gov Identifier: NCT01761435 (registered 13 December 2012). EudraCT Identifier: 2011-003243-21 (registered 4 July 2011). Clinical Trial, Phase III; Comparative Study; Journal Article; Multicenter Study; Randomized Controlled Trial; Research Support, Non-U.S. Gov't;
URI: http://hdl.handle.net/10668/2743
Versión del editor : http://www.trialsjournal.com/content/15/1/338/abstract
DOI: 10.1186/1745-6215-15-338
ISSN : 1745-6215 (Online)
Appears in Collections:01- Artículos - Hospital Reina Sofía
01- Artículos - IBIS. Instituto de Biomedicina de Sevilla
01- Artículos - Hospital Virgen del Rocío
01- Artículos - Hospital Virgen Macarena

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