Infection in Solid Organ Transplant RecipientsPhase 3TraNsgripeNCT01761435
Clinical Trial Evaluating Efficacy and Safety of One Dose Versus Two Doses of Influenza Vaccination
A Phase 3 study testing Influenza vaccine in people with Infection in Solid Organ Transplant Recipients, run by Fundación Pública Andaluza Progreso y Salud at 12 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Infection in Solid Organ Transplant Recipients
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 499 participants
- Where
- 12 sitesSpain
- Study dates
- Oct 2012to Jan 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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).
Trial locations and contacts
12 sites in 1 country.
12 sites in 1 country
Spain12 sites
Hospital Clinic Provincial de Barcelona
Barcelona, Barcelona
Hospital Universitario de Bellvitge
Barcelona, Barcelona
Hospital Universitario de Cruces
Bilbao, Bilbao
Hospital Universitario Reina Sofía
Córdoba, Córdoba
Hospital General Gregorio Marañon
Madrid, Madrid
Hospital Ramón y Cajal
Madrid, Madrid
Hospital Universitario 12 Octubre
Madrid, Madrid
Hospital Vall d'Hebron
Madrid, Madrid
Hospital Universitario Masqués de Valdecilla
Santander, Bilbao
Hospital Universitario Virgen del Rocío
Seville, Sevilla, 41013
Hospital Regional Virgen de la Macarena
Seville, Sevilla
Hospital la Fe de Valencia
Valencia, Valencia
About this study
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
Randomized, multicenter, open label trial to compare safety and efficacy of two doses stationary flu vaccination vs one doses in Solid Organ Transplant Recipients.
Read the detailed description
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.
- Being tested
- Influenza vaccine
- Keywords
- Influenza, Solid Organ Transplant Recipients
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Influenza vaccineBiological
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 group | Role | What they receive |
|---|---|---|
| Influenza vaccine, second administration after 5 weeks | Experimental | Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first one. Receives: Biological: Influenza vaccine |
| Influenza vaccine | Active comparator | Drug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline. Receives: Biological: Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
Secondary outcomes (6)
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).
Measured: At 5, 10, 15 weeks, and 12 months after the first vaccine dose.
Safety.
Occurrence of grade 3 or 4 toxicity, death, hospitalization, retransplantation, acute rejection and chronic rejection
Measured: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
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).
Measured: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
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.
Measured: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
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.
Measured: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
Clinical complications
Clinical severity (hospitalization, ICU admission, death, rejection). Time to clinical stability will be register.
Measured: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2013 (estimated)
- Study startOct 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Infection in Solid Organ Transplant RecipientsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundación Pública Andaluza Progreso y Salud
- Sponsor type
- University, hospital or other
- Collaborators
- Spanish Network for Research in Infectious Diseases
- Responsible party
- Sponsor
- Investigators
- Julian De la Torre Cisneros, PhD, Principal investigator, COMPLEJO HOSPITALARIO REGIONAL REINA SOFÍAFrancisco López Medrano, PhD, Principal investigator, Hospital Universitario 12 de OctubrePatricia Muñoz García, PhD, Principal investigator, HOSPITAL GENERAL GREGORIO MARAÑÓNJesús Fortun Abete, PhD, Principal investigator, Hospital Universitario Ramon y CajalJoán Gavaldà Santapau, PhD, Principal investigator, HOSPITALS VALL D'HEBRONJordi Carratalá Fernández, PhD, Principal investigator, Hospital Universitari de BellvitgeAsunción Moreno Camacho, PhD, Principal investigator, Hospital Clinic of BarcelonaJosé Miguel Montejo Baranda, PhD, Principal investigator, HOSPITAL UNIVERSITARIO DE CRUCES
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01761435
- Sponsor's protocol ID
- TraNsgripe1-2
- Acronym
- TraNsgripe
- Status last verified
- Apr 2015
- First submitted
- 13 Dec 2012
- Last updated
- 1 May 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Demetz G, Laux M, Scherhag A, Hoekstra T, Suttorp MM, Dekker F, Roest M, Marcus-Kalish M, Mittelman M, Ott I. The influence of Erythropoietin on platelet activation, thrombin generation and FVII/active FVII in patients with AMI. Thromb J. 2014 Aug 28;12:18. doi: 10.1186/1477-9560-12-18. eCollection 2014.
PubMed 25228850Martinez-Atienza J, Rosso-Fernandez C, Roca C, Aydillo TA, Gavalda J, Moreno A, Montejo JM, Torre-Cisneros J, Farinas MC, Fortun J, Sabe N, Munoz P, Blanes-Julia M, Suarez-Benjumea A, Lopez-Medrano F, Perez-Romero P, Cordero E; TRANSGRIPE 1-2 Study Group. Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial. Trials. 2014 Aug 28;15:338. doi: 10.1186/1745-6215-15-338.
PubMed 25168918
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01761435
- Acronym / sponsor ID
- TraNsgripe / TraNsgripe1-2
- Keywords
- Influenza, Solid Organ Transplant Recipients
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 499 participants (actual)
- Lead sponsor
- Fundación Pública Andaluza Progreso y SaludUniversity, hospital or other
- Collaborators
- Spanish Network for Research in Infectious Diseases
- Study start
- Oct 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 4 Jan 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Influenza vaccine, second administration after 5 weeks | Experimental | Biological: Influenza vaccineDrug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline and 5 weeks after the first one. |
| Influenza vaccine | Active comparator | Biological: Influenza vaccineDrug: Influenza vaccine (split virion, inactivated) suspension for injection 0.5ml at the baseline. |
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Influenza vaccinePatients 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. | Biological | Influenza vaccine, Influenza vaccine, second administration after 5 weeks |
Primary outcome
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).
6 secondary outcomes
Postvaccination antibody titers
Time frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose.
Safety.
Time frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
Efficacy
Time frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
Antibody anti-HLA
Time frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
Cellular response
Time frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
Clinical complications
Time frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 May 2015.
- Derived from this study: PubMed 25228850Demetz G, Laux M, Scherhag A, Hoekstra T, Suttorp MM, Dekker F, Roest M, Marcus-Kalish M, Mittelman M, Ott I. The influence of Erythropoietin on platelet activation, thrombin generation and FVII/active FVII in patients with AMI. Thromb J. 2014 Aug 28;12:18. doi: 10.1186/1477-9560-12-18. eCollection 2014.
- Derived from this study: PubMed 25168918Martinez-Atienza J, Rosso-Fernandez C, Roca C, Aydillo TA, Gavalda J, Moreno A, Montejo JM, Torre-Cisneros J, Farinas MC, Fortun J, Sabe N, Munoz P, Blanes-Julia M, Suarez-Benjumea A, Lopez-Medrano F, Perez-Romero P, Cordero E; TRANSGRIPE 1-2 Study Group. Efficacy and safety of a booster dose of influenza vaccination in solid organ transplant recipients, TRANSGRIPE 1-2: study protocol for a multicenter, randomized, controlled clinical trial. Trials. 2014 Aug 28;15:338. doi: 10.1186/1745-6215-15-338.
- 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 basicLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
12 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Influenza vaccine in people with Infection in Solid Organ Transplant Recipients, run by Fundación Pública Andaluza Progreso y Salud at 12 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 1 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 12 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Seroconversion rates (time frame: At 5, 10, 15 weeks, and 12 months after the first vaccine dose). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01761435, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 May 2015.