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| Name | Class |
|---|---|
| Spanish Network for Research in Infectious Diseases | OTHER |
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Randomized, multicenter, open label trial to compare safety and efficacy of two doses stationary flu vaccination vs one doses in Solid Organ Transplant Recipients.
The purposes of this study are:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Influenza vaccine, second administration after 5 weeks | Experimental | Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first one. |
|
| Influenza vaccine | Active Comparator | Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Influenza vaccine | Biological | Patients will be randomized at 1:1 rate and open label fashion, according to centers, and time elapsed since transplant and type of organ transplanted to one of this two interventions : A arm (usual treatment): Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline. B arm (experimental branch): Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first dose. The follow-up of both arms will be at 5, 10 and 15 weeks and one year after the baseline. |
| Measure | Description | Time Frame |
|---|---|---|
| Seroconversion rates | Difference in seroconversion rates in both treatment groups at 5, 10, 15 weeks, and 12 months after the first vaccine dose (percent of patients with 4 x increase in the pre-vaccination titers). | At 5, 10, 15 weeks, and 12 months after the first vaccine dose |
| Measure | Description | Time Frame |
|---|---|---|
| Postvaccination antibody titers | Geometric average postvaccination antibody titers and rate of increase between pre-and post-vaccination geometric mean, post-vaccination seroprotection rate (or percentage of individuals with a titer 1 / 40 as measured by RIH). | At 5, 10, 15 weeks, and 12 months after the first vaccine dose. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Julian De la Torre Cisneros, PhD | COMPLEJO HOSPITALARIO REGIONAL REINA SOFÍA | Principal Investigator |
| Francisco López Medrano, PhD | Hospital Universitario 12 de Octubre | Principal Investigator |
| Patricia Muñoz García, PhD | HOSPITAL GENERAL GREGORIO MARAÑÓN | Principal Investigator |
| Jesús Fortun Abete, PhD | Hospital Universitario Ramon y Cajal | Principal Investigator |
| Joán Gavaldà Santapau, PhD | HOSPITALS VALL D'HEBRON | Principal Investigator |
| Jordi Carratalá Fernández, PhD | Hospital Universitari de Bellvitge | Principal Investigator |
| Asunción Moreno Camacho, PhD | Hospital Clinic of Barcelona | Principal Investigator |
| José Miguel Montejo Baranda, PhD | HOSPITAL UNIVERSITARIO DE CRUCES | Principal Investigator |
| Marino Blanes Julia, PhD | Hospital Universitario La Fe |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic Provincial de Barcelona | Barcelona | Barcelona | Spain | |||
| Hospital Universitario de Bellvitge |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25228850 | Derived | Demetz G, Laux M, Scherhag A, Hoekstra T, Suttorp MM, Dekker F, Roest M, Marcus-Kalish M, Mittelman M, Ott I. The influence of Erythropoietin on platelet activation, thrombin generation and FVII/active FVII in patients with AMI. Thromb J. 2014 Aug 28;12:18. doi: 10.1186/1477-9560-12-18. eCollection 2014. | |
| 25168918 | Derived |
| Label | URL |
|---|---|
| The Spanish Network for the Research in Infectious Diseases (REIPI) is based in research groups of high standards and professional level. REIPI´s aim is to generate scientific knowledge in the field of the infectious diseases, in areas ranging from basic | View source |
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|
| Safety. |
Occurrence of grade 3 or 4 toxicity, death, hospitalization, retransplantation, acute rejection and chronic rejection |
| At 5, 10, 15 weeks, and 12 months after the first vaccine dose |
| Efficacy | Detection of clinical cases of influenza following immunization. Nasal swabs to confirm infection with influenza virus by RT-PCR (Reverse transcription polymerase chain reaction). | At 5, 10, 15 weeks, and 12 months after the first vaccine dose |
| Antibody anti-HLA | Characterize the flu vaccine effect (one dose and two doses) through the antibody anti-HLA levels, ant its influence on the rejection rate in solid organ transplant recipients, by means of immunologic sub-study. | At 5, 10, 15 weeks, and 12 months after the first vaccine dose |
| Cellular response | Determination of the T cells specific immune response measured by production of INFg, IL-2 and IL-4 in the cytoplasm of CD4+ and CD8 + (mononuclear cells) specific for influenza virus by direct immunofluorescence and flow cytometry analysis. | At 5, 10, 15 weeks, and 12 months after the first vaccine dose |
| Clinical complications | Clinical severity (hospitalization, ICU admission, death, rejection). Time to clinical stability will be register. | At 5, 10, 15 weeks, and 12 months after the first vaccine dose |
| Alejandro Suarez Benjumea, PhD | COMPLEJO HOSPITALARIO REGIONAL VIRGEN MACARENA | Principal Investigator |
| Carmen Fariñas Álvarez, PhD | Hospital Universitario Marqués de Valdecilla | Principal Investigator |
| Maria Elisa Cordero Matia, PhD | Hospitales Universitarios Virgen del Rocío | Principal Investigator |
| Barcelona |
| Barcelona |
| Spain |
| Hospital Universitario de Cruces | Bilbao | Bilbao | Spain |
| Hospital Universitario Masqués de Valdecilla | Santander | Bilbao | Spain |
| Hospital Universitario Reina Sofía | Córdoba | Córdoba | Spain |
| Hospital General Gregorio Marañon | Madrid | Madrid | Spain |
| Hospital Ramón y Cajal | Madrid | Madrid | Spain |
| Hospital Universitario 12 Octubre | Madrid | Madrid | Spain |
| Hospital Vall d'Hebron | Madrid | Madrid | Spain |
| Hospital Universitario Virgen del Rocío | Seville | Sevilla | 41013 | Spain |
| Hospital Regional Virgen de la Macarena | Seville | Sevilla | Spain |
| Hospital la Fe de Valencia | Valencia | Valencia | Spain |
| Martinez-Atienza J, Rosso-Fernandez C, Roca C, Aydillo TA, Gavalda J, Moreno A, Montejo JM, Torre-Cisneros J, Farinas MC, Fortun J, Sabe N, Munoz P, Blanes-Julia M, Suarez-Benjumea A, Lopez-Medrano F, Perez-Romero P, Cordero E; TRANSGRIPE 1-2 Study Group. 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 Aug 28;15:338. doi: 10.1186/1745-6215-15-338. |
| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| D007252 | Influenza Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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