Clinical trial NCT01761435: Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination
Official title: Randomized, Comparative and Prospective Clinical Trial Evaluating Efficacy and Safety of a Dose of Seasonal Flu Vaccine Compared to Two Doses of Vaccine for Prevention of Influenza in Solid Organ Transplant Recipients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Infection in Solid Organ Transplant Recipients
Keywords: Influenza
Solid Organ Transplant Recipients
Lead sponsor: Andalusian Network for Design and Translation of Advanced Therapies
Sponsor class: OTHER
Collaborators: name: Spanish Network for Research in Infectious Diseases
First posted: 2013-01-04
Enrollment: 499
Sex: ALL
Minimum age (years): 16
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: Randomized, multicenter, open label trial to compare safety and efficacy of two doses stationary flu vaccination vs one doses in Solid Organ Transplant Recipients.

Detailed description: The purposes of this study are:

1. Evaluate the efficacy and safety of a double dose of seasonal flu vaccine compared to a single dose.
2. Determine the specific cellular immune response produced after the first and second vaccine doses of seasonal flu vaccine by in vitro stimulation of specific memory cells (A and B flu viruses).
3. Evaluate the humoral immune response produced after one dose vs two doses of seasonal flu vaccine by the measure of serum antibody levels.
4. Evaluate clinical efficacy of stationary flu vaccine in solid organ transplant recipients.
5. Evaluate a long term cellular and humoral response(1 year) of seasonal flu vaccine.
6. Characterize the genetic expression profile of immune response after the flu vaccine in solid organ transplant recipients by means of a genetic sub-study.
7. Characterize the flu vaccine effect (one dose and two doses) through the antibody anti-HLA(human leukocyte antigen), and its influence on the rejection rate in solid organ transplant recipients, by means of immunologic sub-study.

Eligibility criteria: Inclusion Criteria:

1. Solid organ transplant recipient.
2. 16 years or older.
3. More than 30 days after transplantation.
4. Negative pregnancy test for women of childbearing potential
5. The patient must give informed consent

Exclusion Criteria:

1. No written informed consent.
2. Acute rejection within 15 days prior to vaccination.
3. Pregnancy.
4. Hypersensitivity to the active substance, any of the excipients and waste, for example: eggs, egg albumin, chicken proteins.
5. History of a previous serious reaction to immunization (eg Guillain-Barré syndrome).

Primary outcomes:
measure: Seroconversion rates
timeFrame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
Secondary outcomes:
measure: Postvaccination antibody titers
timeFrame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose.
measure: Safety.
timeFrame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
measure: Efficacy
timeFrame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
measure: Antibody anti-HLA
timeFrame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
measure: Cellular response
timeFrame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
measure: Clinical complications
timeFrame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Masqués de Valdecilla
state: Bilbao
city: Barcelona
country: Spain
facility: Hospital Clinic Provincial de Barcelona
city: Barcelona
country: Spain
facility: Hospital Universitario de Bellvitge
city: Bilbao
country: Spain
facility: Hospital Universitario de Cruces
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital General Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Ramón y Cajal
city: Madrid
country: Spain
facility: Hospital Universitario 12 Octubre
city: Madrid
country: Spain
facility: Hospital Vall d'Hebron
city: Sevilla
country: Spain
facility: Hospital Universitario Virgen del Rocío
city: Sevilla
country: Spain
facility: Hospital Regional Virgen de la Macarena
city: Valencia
country: Spain
facility: Hospital la Fe de Valencia
Study officials:
affiliation: COMPLEJO HOSPITALARIO REGIONAL REINA SOFÍA
name: Julian De la Torre Cisneros, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario 12 de Octubre
name: Francisco López Medrano, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITAL GENERAL GREGORIO MARAÑÓN
name: Patricia Muñoz García, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Ramon y Cajal
name: Jesús Fortun Abete, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITALS VALL D'HEBRON
name: Joán Gavaldà Santapau, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitari de Bellvitge
name: Jordi Carratalá Fernández, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Clinic i provincial de Barcelona
name: Asunción Moreno Camacho, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: HOSPITAL UNIVERSITARIO DE CRUCES
name: José Miguel Montejo Baranda, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Fe
name: Marino Blanes Julia, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: COMPLEJO HOSPITALARIO REGIONAL VIRGEN MACARENA
name: Alejandro Suarez Benjumea, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Marqués de Valdecilla
name: Carmen Fariñas Álvarez, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario Virgen del Rocio
name: Maria Elisa Cordero Matia, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.