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

Overview

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

Full Title of Study: “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

  • Study Type: Interventional
  • Study Design
    • Allocation: Randomized
    • Intervention Model: Parallel Assignment
    • Primary Purpose: Prevention
    • Masking: None (Open Label)
  • Study Primary Completion Date: January 2014

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.

Interventions

  • 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.

Arms, Groups and Cohorts

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

Clinical Trial Outcome Measures

Primary Measures

  • 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).

Secondary Measures

  • 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.

Participating in This Clinical Trial

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).

Gender Eligibility: All

Minimum Age: 16 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Fundación Pública Andaluza Progreso y Salud
  • Collaborator
    • Spanish Network for Research in Infectious Diseases
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Official(s)
    • Julian De la Torre Cisneros, PhD, Principal Investigator, COMPLEJO HOSPITALARIO REGIONAL REINA SOFÍA
    • Francisco López Medrano, PhD, Principal Investigator, Hospital Universitario 12 de Octubre
    • Patricia Muñoz García, PhD, Principal Investigator, HOSPITAL GENERAL GREGORIO MARAÑÓN
    • Jesús Fortun Abete, PhD, Principal Investigator, Hospital Universitario Ramon y Cajal
    • Joán Gavaldà Santapau, PhD, Principal Investigator, HOSPITALS VALL D’HEBRON
    • Jordi Carratalá Fernández, PhD, Principal Investigator, Hospital Universitari de Bellvitge
    • Asunción Moreno Camacho, PhD, Principal Investigator, Hospital Clinic i provincial de Barcelona
    • José Miguel Montejo Baranda, PhD, Principal Investigator, HOSPITAL UNIVERSITARIO DE CRUCES
    • Marino Blanes Julia, PhD, Principal Investigator, Hospital Universitario La Fe
    • Alejandro Suarez Benjumea, PhD, Principal Investigator, COMPLEJO HOSPITALARIO REGIONAL VIRGEN MACARENA
    • Carmen Fariñas Álvarez, PhD, Principal Investigator, Hospital Universitario Marqués de Valdecilla
    • Maria Elisa Cordero Matia, PhD, Principal Investigator, Hospital Universitario Virgen del Rocio

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