Kidney TransplantPIP-02NCT00833651
Protective Immunity Project 02
An observational study of Kidney Transplant and Immunology, run by Emory University at 1 site in United States.
Trial summary
Influenza (Flu) vaccine is recommended for kidney transplant patients who are at least 6 months post-transplant. The influenza vaccine stimulates the immune system to builds protective antibodies against the flu virus. Read more about this study
- Who is it for?
- Ages 18 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Kidney Transplant, Immunology, Immunosuppression
- How many people
- 97 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2006to Oct 2011
- Phase
- Observational
- 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 18 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Adult (ages 18-59) recipients of deceased or living donor renal transplants
Who may be able to join
- Male or female patients between 18 and 59 years of age
- Greater than six months post deceased or living donor renal transplant
- Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
- Patients with no known contraindications to flu vaccine (e.g. egg allergy, prior serious adverse reaction to flu vaccine, current febrile illness, marked leukopenia (WBC < 2500 cells/ml)
- Women of childbearing potential must have a negative serum pregnancy test within 7 days of study enrollment and must not be breast-feeding.
Who cannot join
- 1. Patients with evidence of an active systemic infection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective Comparison of the Magnitude and Character of the Immune Response to Influenza Vaccine in Immunosuppressed Renal Transplant Patients and Healthy Age-matched Volunteers
Influenza (Flu) vaccine is recommended for kidney transplant patients who are at least 6 months post-transplant. The influenza vaccine stimulates the immune system to builds protective antibodies against the flu virus.
Previous research has shown that adult kidney transplant patients are not able to form as much of these protective antibodies as compared to healthy volunteers. Research has also suggested that different immunosuppressive medicines may have different effects on antibody formation. In this study, we hope to evaluate these differences in more detail.
Read more
In recent years, increasingly effective, but also increasingly complex, immunosuppressive regimens have been developed, however, there has been little detailed systematic study of the immune changes that occur in response to vaccination with these newer immunosuppressive regimens.Current policies on vaccination of transplant recipients are generic and continue to be based on old concepts rather than on any new understanding of the effects of these newer therapies on the immune system.
We hope to improve our understanding of the effects of the immunosuppressive regimens in use today (calcineurin-inhibitor, or CNI, and sirolimus-based regimens) on immune response to flu vaccine. Such knowledge will be critical to helping clinicians develop strategies for getting desirable immune responses while not causing rejection.
- Conditions
- Kidney Transplant, Immunology, Immunosuppression
- Keywords
- Transplant, Immunology, Immunosuppression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| tacrolimus | Recipients of primary deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing tacrolimus | |
| sirolimus | Recipients of primary deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing sirolimus | |
| Healthy controls | Age, gender- and race-matched individuals, not on immunosuppressive medications |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the effect of immunosuppressive regimens on the magnitude and character of the adaptive immune response to flu vaccine
Measured: 7, 14, 28 and 90 days post vaccination
To determine the effects of chronic immunosuppressive therapies on innate immunity during response to flu vaccine
Measured: 7, 14, 28 and 90 days post vaccination
To define the transcriptional and protein signatures of the response to flu vaccination in patients on conventional immunosuppressive regimens compared to healthy volunteers
Measured: 7, 14, 28 and 90 days post vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2009 (estimated)
- Study startNov 2006
- Primary completionFeb 2010
- Study completionOct 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney TransplantStudies of the same condition, open and under way.
- More trials run by Emory UniversityThe sponsor's other registered studies.
- 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- Emory University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian P Larsen, MD, PhD, Emory University
- Investigators
- Christian P. Larsen, MD, DPhil, Principal investigator, Emory UniversityKenneth E Kokko, MD, PhD, Principal investigator, Emory University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00833651
- Sponsor's protocol ID
- IRB00024793
- Other IDs
- PIP-02
- Acronym
- PIP-02
- Status last verified
- Nov 2013
- First submitted
- 30 Jan 2009
- Last updated
- 25 Nov 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Comparison of the Magnitude and Character of the Immune Response to Influenza Vaccine in Immunosuppressed Renal Transplant Patients and Healthy Age-matched Volunteers
- ClinicalTrials.gov ID
- NCT00833651
- Acronym / sponsor ID
- PIP-02 / IRB00024793
- Conditions
- Kidney Transplant, Immunology, Immunosuppression
- Keywords
- Transplant, Immunology, Immunosuppression
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- Emory UniversityUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Feb 2010 (actual)
- Study completion
- Oct 2011 (actual)
- First posted
- 2 Feb 2009 (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.
Influenza (Flu) vaccine is recommended for kidney transplant patients who are at least 6 months post-transplant. The influenza vaccine stimulates the immune system to builds protective antibodies against the flu virus.
Previous research has shown that adult kidney transplant patients are not able to form as much of these protective antibodies as compared to healthy volunteers. Research has also suggested that different immunosuppressive medicines may have different effects on antibody formation. In this study, we hope to evaluate these differences in more detail.
In recent years, increasingly effective, but also increasingly complex, immunosuppressive regimens have been developed, however, there has been little detailed systematic study of the immune changes that occur in response to vaccination with these newer immunosuppressive regimens.Current policies on vaccination of transplant recipients are generic and continue to be based on old concepts rather than on any new understanding of the effects of these newer therapies on the immune system.
We hope to improve our understanding of the effects of the immunosuppressive regimens in use today (calcineurin-inhibitor, or CNI, and sirolimus-based regimens) on immune response to flu vaccine. Such knowledge will be critical to helping clinicians develop strategies for getting desirable immune responses while not causing rejection.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| tacrolimus | – | –Recipients of primary deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing tacrolimus |
| sirolimus | – | –Recipients of primary deceased or living donor renal transplant maintained on immunosuppressive regimen utilizing sirolimus |
| Healthy controls | – | –Age, gender- and race-matched individuals, not on immunosuppressive medications |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Adult (ages 18-59) recipients of deceased or living donor renal transplants
Key inclusion criteria (5 listed)
- Male or female patients between 18 and 59 years of age
- Greater than six months post deceased or living donor renal transplant
- Patients capable of understanding the purposes and risks of the study, who can give written informed consent and who are willing to participate in and comply with the study.
- Patients with no known contraindications to flu vaccine (e.g. egg allergy, prior serious adverse reaction to flu vaccine, current febrile illness, marked leukopenia (WBC < 2500 cells/ml)
- Women of childbearing potential must have a negative serum pregnancy test within 7 days of study enrollment and must not be breast-feeding.
Key exclusion criteria (1 listed)
- 1. Patients with evidence of an active systemic infection
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
To determine the effect of immunosuppressive regimens on the magnitude and character of the adaptive immune response to flu vaccine
Time frame: 7, 14, 28 and 90 days post vaccination
To determine the effects of chronic immunosuppressive therapies on innate immunity during response to flu vaccine
Time frame: 7, 14, 28 and 90 days post vaccination
To define the transcriptional and protein signatures of the response to flu vaccination in patients on conventional immunosuppressive regimens compared to healthy volunteers
Time frame: 7, 14, 28 and 90 days post vaccination
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 25 Nov 2013.
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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.
Christian P. Larsen, MD, DPhil principal investigator
Emory University
Kenneth E Kokko, MD, PhD principal investigator
Emory University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Kidney Transplant and Immunology, run by Emory University at 1 site in United States.
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 1 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 25 Nov 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. 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.
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?
To determine the effect of immunosuppressive regimens on the magnitude and character of the adaptive immune response to flu vaccine (time frame: 7, 14, 28 and 90 days post vaccination). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Nov 2013; AzTrials last refreshed its copy on 31 Oct 2026.