Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination (TraNsgripe)

This study is currently recruiting participants. (see Contacts and Locations)
Verified November 2013 by Fundación Pública Andaluza Progreso y Salud
Sponsor:
Collaborator:
Spanish Network for Research in Infectious Diseases
Information provided by (Responsible Party):
Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier:
NCT01761435
First received: December 13, 2012
Last updated: November 4, 2013
Last verified: November 2013
  Purpose

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


Condition Intervention Phase
Infection in Solid Organ Transplant Recipients
Biological: Influenza vaccine
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
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

Resource links provided by NLM:


Further study details as provided by Fundación Pública Andaluza Progreso y Salud:

Primary Outcome Measures:
  • Seroconversion rates [ Time Frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • Postvaccination antibody titers [ Time Frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose. ] [ Designated as safety issue: No ]
    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).

  • Safety. [ Time Frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose ] [ Designated as safety issue: Yes ]
    Occurrence of grade 3 or 4 toxicity, death, hospitalization, retransplantation, acute rejection and chronic rejection

  • Efficacy [ Time Frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose ] [ Designated as safety issue: No ]
    Detection of clinical cases of influenza following immunization. Nasal swabs to confirm infection with influenza virus by RT-PCR (Reverse transcription polymerase chain reaction).

  • Antibody anti-HLA [ Time Frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose ] [ Designated as safety issue: No ]
    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.

  • Cellular response [ Time Frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose ] [ Designated as safety issue: No ]
    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.

  • Clinical complications [ Time Frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose ] [ Designated as safety issue: Yes ]
    Clinical severity (hospitalization, ICU admission, death, rejection). Time to clinical stability will be register.


Estimated Enrollment: 499
Study Start Date: October 2012
Estimated Study Completion Date: March 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Influenza vaccine, second administration after 5 weeks
Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first one.
Biological: Influenza vaccine

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.

Active Comparator: Influenza vaccine
Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline.
Biological: Influenza vaccine

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.


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

Ages Eligible for Study:   16 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01761435

Contacts
Contact: Maria Elisa Cordero Matia, PhD +34 955 013414 mariae.cordero.sspa@juntadeandalucia.es
Contact: Clara María Rosso, MD +34 955013414 claram.rosso.sspa@juntadeandalucia.es

Locations
Spain
Hospital Universitario Masqués de Valdecilla Recruiting
Santander, Bilbao, Spain
Contact: Carmen Fariñas Álvarez, MD    +34 942203263    mirfac@humv.es   
Hospital Universitario de Bellvitge Recruiting
Barcelona, Spain
Contact: Jordi Carratalá Fernández, MD    + 34 932 607 625    jcarratala@bellvitgehospital.cat   
Hospital Clinic Provincial de Barcelona Recruiting
Barcelona, Spain
Contact: Asunción Moreno Camacho, MD    637723240    AMORENO@clinic.ub.es   
Hospital Universitario de Cruces Recruiting
Bilbao, Spain
Contact: Miguel Montejo Baranda, MD    686913317    josemiguelmontejo@hotmail.com   
Hospital Universitario Reina Sofía Recruiting
Córdoba, Spain
Contact: Juliián de la Torre Cisneros, DM    677 904 280    julian.torre.sspa@juntadeandalucia.es   
Contact: Rosario Lara Contreras, DM    670 781 024    laracharo@gmail.com   
Hospital Universitario 12 Octubre Recruiting
Madrid, Spain
Contact: Francisco López Medrano, DM    649 944 975    flmedrano@yahoo.es   
Hospital General Gregorio Marañon Recruiting
Madrid, Spain
Contact: Patricia Muñoz García, MD         
Hospital Ramón y Cajal Recruiting
Madrid, Spain
Contact: Jesús Fortún Abete    662435553    fortunabete@gmail.com   
Hospital Vall d'Hebron Recruiting
Madrid, Spain
Contact: Joan Gavaldà Santapau, MD         
Hospital Universitario Virgen del Rocío Recruiting
Sevilla, Spain, 41013
Contact: María Elisa Cordero, MD    34 955 013414    mariae.cordero.sspa@juntadeandalucia.es   
Contact: Clara María Rosso, MD    34 955 013414    claram.rosso.sspa@juntadeandalucia.es   
Hospital Regional Virgen de la Macarena Recruiting
Sevilla, Spain
Contact: Alejandro Suárez Benjumea    +34 954533558    suarezbenjumea@gmail.com   
Hospital la Fe de Valencia Recruiting
Valencia, Spain
Contact: Mario Blanes Julia, MD    +34 963 726517    mblanes@ono.com   
Sponsors and Collaborators
Fundación Pública Andaluza Progreso y Salud
Spanish Network for Research in Infectious Diseases
Investigators
Principal Investigator: 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 I PROVINCIAL DE BARCELONA
Principal Investigator: José Miguel Montejo Baranda, PhD HOSPITAL UNIVERSITARIO DE CRUCES
Principal Investigator: Marino Blanes Julia, PhD HOSPITAL UNIVERSITARI I POLITÈCNIC LA FE
Principal Investigator: 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 HOSPITAL UNIVERSITARIO VIRGEN DEL ROCIO
  More Information

Additional Information:
No publications provided

Responsible Party: Fundación Pública Andaluza Progreso y Salud
ClinicalTrials.gov Identifier: NCT01761435     History of Changes
Other Study ID Numbers: TraNsgripe1-2
Study First Received: December 13, 2012
Last Updated: November 4, 2013
Health Authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios

Keywords provided by Fundación Pública Andaluza Progreso y Salud:
Influenza
Solid Organ Transplant Recipients

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 29, 2014