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

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ClinicalTrials.gov Identifier: NCT01761435
Recruitment Status : Completed
First Posted : January 4, 2013
Last Update Posted : May 1, 2015
Sponsor:
Collaborator:
Spanish Network for Research in Infectious Diseases
Information provided by (Responsible Party):
Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud )

Tracking Information
First Submitted Date  ICMJE December 13, 2012
First Posted Date  ICMJE January 4, 2013
Last Update Posted Date May 1, 2015
Study Start Date  ICMJE October 2012
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
Seroconversion rates [ Time Frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose ]
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).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: January 3, 2013)
  • Postvaccination antibody titers [ Time Frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose. ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    Clinical severity (hospitalization, ICU admission, death, rejection). Time to clinical stability will be register.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination
Official Title  ICMJE 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
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Condition  ICMJE Infection in Solid Organ Transplant Recipients
Intervention  ICMJE 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.

Study Arms  ICMJE
  • 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.
    Intervention: Biological: Influenza vaccine
  • Active Comparator: Influenza vaccine
    Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline.
    Intervention: Biological: Influenza vaccine
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: November 4, 2013)
499
Original Estimated Enrollment  ICMJE
 (submitted: January 3, 2013)
508
Actual Study Completion Date  ICMJE January 2014
Actual Primary Completion Date January 2014   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Spain
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01761435
Other Study ID Numbers  ICMJE TraNsgripe1-2
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Andalusian Network for Design and Translation of Advanced Therapies ( Fundación Pública Andaluza Progreso y Salud )
Study Sponsor  ICMJE Fundación Pública Andaluza Progreso y Salud
Collaborators  ICMJE Spanish Network for Research in Infectious Diseases
Investigators  ICMJE
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 Universitario 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
PRS Account Andalusian Network for Design and Translation of Advanced Therapies
Verification Date April 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP