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
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Condition or disease | Intervention/treatment | Phase |
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Infection in Solid Organ Transplant Recipients | Biological: Influenza vaccine | Phase 3 |
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.
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 499 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | None (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 |
Study Start Date : | October 2012 |
Actual Primary Completion Date : | January 2014 |
Actual Study Completion Date : | January 2014 |

Arm | Intervention/treatment |
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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.
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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. |
- 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).
- 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.

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Ages Eligible for Study: | 16 Years and older (Child, Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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).

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01761435
Spain | |
Hospital Universitario Masqués de Valdecilla | |
Santander, Bilbao, Spain | |
Hospital Clinic Provincial de Barcelona | |
Barcelona, Spain | |
Hospital Universitario de Bellvitge | |
Barcelona, Spain | |
Hospital Universitario de Cruces | |
Bilbao, Spain | |
Hospital Universitario Reina Sofía | |
Córdoba, Spain | |
Hospital General Gregorio Marañon | |
Madrid, Spain | |
Hospital Ramón y Cajal | |
Madrid, Spain | |
Hospital Universitario 12 Octubre | |
Madrid, Spain | |
Hospital Vall d'Hebron | |
Madrid, Spain | |
Hospital Universitario Virgen del Rocío | |
Sevilla, Spain, 41013 | |
Hospital Regional Virgen de la Macarena | |
Sevilla, Spain | |
Hospital la Fe de Valencia | |
Valencia, Spain |
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 |
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: | Fundación Pública Andaluza Progreso y Salud |
ClinicalTrials.gov Identifier: | NCT01761435 |
Other Study ID Numbers: |
TraNsgripe1-2 |
First Posted: | January 4, 2013 Key Record Dates |
Last Update Posted: | May 1, 2015 |
Last Verified: | April 2015 |
Influenza Solid Organ Transplant Recipients |
Influenza, Human Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases |