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NCT Number: NCT01761435

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

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

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Key information

Conditions

Infection in Solid Organ Transplant Recipients Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

16 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Hospital Clinic Provincial de Barcelona, Barcelona, Spain

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About this study

The purposes of this study are:

  • Evaluate the efficacy and safety of a double dose of seasonal flu vaccine compared to a single dose.
  • 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).
  • Evaluate the humoral immune response produced after one dose vs two doses of seasonal flu vaccine by the measure of serum antibody levels.
  • Evaluate clinical efficacy of stationary flu vaccine in solid organ transplant recipients.
  • Evaluate a long term cellular and humoral response(1 year) of seasonal flu vaccine.
  • Characterize the genetic expression profile of immune response after the flu vaccine in solid organ transplant recipients by means of a genetic sub-study.
  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

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.

Primary outcomes

  1. 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 outcomes

  1. 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).

  2. 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

  3. 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).

  4. 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.

  5. 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.

  6. 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.

Sponsors and collaborators

Lead sponsor

Fundación Pública Andaluza Progreso y Salud

Other

Collaborators

  • Spanish Network for Research in Infectious Diseases

Registry information

Official study 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

Acronym: TraNsgripe

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Jan 4, 2013
Registry last updated
May 1, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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