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

Infection in Solid Organ Transplant Recipients Clinical Trial

— TraNsgripe  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01761435
• Other study ID #: TraNsgripe1-2
• Status: Completed
• Phase: Phase 3
• First received: December 13, 2012
• Last updated: April 30, 2015
• Start date: October 2012
• Est. completion date: January 2014

Study information

• Verified date: April 2015
• Source: Andalusian Initiative for Advanced Therapies - Fundación Pública Andaluza Progreso y Salud
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Agencia Española de Medicamentos y Productos Sanitarios
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 499
• Est. completion date: January 2014
• Est. primary completion date: January 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years and older

Eligibility

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).

Study Design

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

Related Conditions & MeSH terms

• Infection in Solid Organ Transplant Recipients

Intervention

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.

Locations

Country	Name	City	State
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 Masqués de Valdecilla	Santander	Bilbao
Spain	Hospital Regional Virgen de la Macarena	Sevilla
Spain	Hospital Universitario Virgen del Rocío	Sevilla
Spain	Hospital la Fe de Valencia	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Fundación Pública Andaluza Progreso y Salud	Spanish Network for Research in Infectious Diseases

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seroconversion rates	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).	At 5, 10, 15 weeks, and 12 months after the first vaccine dose	No
Secondary	Postvaccination antibody titers	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).	At 5, 10, 15 weeks, and 12 months after the first vaccine dose.	No
Secondary	Safety.	Occurrence of grade 3 or 4 toxicity, death, hospitalization, retransplantation, acute rejection and chronic rejection	At 5, 10, 15 weeks, and 12 months after the first vaccine dose	Yes
Secondary	Efficacy	Detection of clinical cases of influenza following immunization. Nasal swabs to confirm infection with influenza virus by RT-PCR (Reverse transcription polymerase chain reaction).	At 5, 10, 15 weeks, and 12 months after the first vaccine dose	No
Secondary	Antibody anti-HLA	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.	At 5, 10, 15 weeks, and 12 months after the first vaccine dose	No
Secondary	Cellular response	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.	At 5, 10, 15 weeks, and 12 months after the first vaccine dose	No
Secondary	Clinical complications	Clinical severity (hospitalization, ICU admission, death, rejection). Time to clinical stability will be register.	At 5, 10, 15 weeks, and 12 months after the first vaccine dose	Yes

External Links

•   The Spanish Network for the Research in Infectious Diseases (REIPI) is based in research groups of high standards and professional level. REIPI´s aim is to generate scientific knowledge in the field of the infectious diseases, in areas ranging from basic