InfluenzaNCT00205270
Influenza Vaccine in Lung Transplant Patients
An observational study of Influenza, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This 5-year study was designed to investigate how antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 126 participants
- Where
- 1 siteUnited States
- Study dates
- Dec 2004to Jul 2009
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adults and patients receiving care pre- or post-lung transplant at University of Wisconsin Hospital
Who may be able to join
- Receiving care pre- or post-lung transplant at University of Wisconsin Hospital
- Healthy adult
Who cannot join
- Allergy to eggs
- Moderate to severe febrile illness
- Active treatment for acute rejection
- Received season's influenza vaccine prior to enrollment
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Antibody Responses to Influenza Vaccine in Pre- and Post-lung Transplant Patients
This 5-year study was designed to investigate how antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals.
Read the detailed description
[Note: there are 6 ClinicalTrials.gov records associated with this study, each representing a different sub-study of the population over the 5-year period, please see NCT04533061, NCT04533139, NCT04531787, NCT04530786, and NCT04531657 for related data]
Although pre-transplant immunization is routinely recommended, this recommendation is based on little data. The primary objective of this study is to compare antibody responses in lung transplant patients who receive influenza vaccine before transplant, within the first six months of transplant, between 13 and 60 months post-transplant, and 110 months or beyond transplant.
This prospective cohort study is to include immunization events performed over five years to measure H1N1, H3N2, and B antibody responses to the influenza vaccine in pre- and post-lung transplant patients. The pre-transplant patients will move to the post-transplant group as the study progressed. Similarly, participants are allowed to move to the next time-since-transplant group as time elapsed.
Serum was collected from participants prior to and two-four weeks following trivalent inactivated influenza immunization for each season.
Geometric mean titers, seroprotection (antibody titer at least 1:40), seroconversion (fourfold increase between pre and post), and mean fold increases will be compared.
- Conditions
- Influenza
- Being tested
- Influenza vaccine
- Keywords
- Pre or post-lung transplant, Healthy
- 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 vaccineDrug
influenza vaccine 0.5 ml intramuscularly each season
| Study group | Role | What they receive |
|---|---|---|
| Pre-transplant Vaccine | Cohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually. Receives: Drug: Influenza vaccine | |
| 0-6 Months Post-transplant Vaccine | Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 0-6 months post transplant. Receives: Drug: Influenza vaccine | |
| 13-60 months Post-transplant Vaccine | Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 13-60 months post transplant. Receives: Drug: Influenza vaccine | |
| Greater than 110 months Post-transplant Vaccine | Cohort consist of individuals who have received lung transplants and received inactivated influenza vaccine greater than 110 months post transplant. Receives: Drug: Influenza vaccine | |
| Healthy Controls | Healthy controls to measure normal immune response to the influenza vaccine Receives: Drug: Influenza vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Antibody response to influenza vaccine
Measured: Each season
Secondary outcomes (1)
T cell response to influenza vaccine antigens
Measured: Each season for the first two seasons
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Sep 2005 (estimated)
- Study startDec 2004
- Primary completionJul 2009
- Study completionJul 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for InfluenzaStudies of the same condition, open and under way.
- More trials run by University of Wisconsin, MadisonThe 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
- 126 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Wisconsin, Madison
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mary S Hayney, PharmD, Principal investigator, University of Wisconsin, Madison
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00205270
- Sponsor's protocol ID
- H-2004-0240
- Other IDs
- A561000, PHARM/PHARMACY/PHARMACY
- Status last verified
- Oct 2020
- First submitted
- 13 Sep 2005
- Last updated
- 23 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Dopp JM, Wiegert NA, Moran JJ, Francois ML, Radford KL, Thomas H, Love RB, Hayney MS. Effect of annual influenza immunization on antibody response in lung transplant patients. Prog Transplant. 2009 Jun;19(2):153-9. doi: 10.1177/152692480901900209.
PubMed 19588665Hayney MS, Moran J, Wiegert NA, Burlingham WJ. Lung transplant patients' T cell responses to influenza vaccine viruses between seasons. Vaccine. 2008 May 19;26(21):2596-600. doi: 10.1016/j.vaccine.2008.03.012. Epub 2008 Mar 31.
PubMed 18420314Moran JJ, Rose WE, Darga AJ, Rohde KA, Hayney MS. Persistence of influenza vaccine-induced antibodies in lung transplant patients between seasons. Transpl Infect Dis. 2011 Oct;13(5):466-70. doi: 10.1111/j.1399-3062.2011.00654.x. Epub 2011 May 27.
PubMed 21615847Severson JJ, Richards KR, Moran JJ, Hayney MS. Persistence of influenza vaccine-induced antibody in lung transplant patients and healthy individuals beyond the season. Hum Vaccin Immunother. 2012 Dec 1;8(12):1850-3. doi: 10.4161/hv.21735. Epub 2012 Aug 21.
PubMed 22906937Long AJ, Worzella SL, Moran JJ, Hayney MS. Influenza vaccine antibody response and 6-month persistence in lung transplant recipients using two definitions of seroprotection. Transplantation. 2015 Apr;99(4):885-9. doi: 10.1097/TP.0000000000000391.
PubMed 25148380Miller RM, Rohde KA, Tingle MT, Moran JJ, Hayney MS. Antibody responses to influenza vaccine in pre- and post-lung transplant patients. Clin Transplant. 2016 May;30(5):606-12. doi: 10.1111/ctr.12726. Epub 2016 Mar 20.
PubMed 26928266
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibody Responses to Influenza Vaccine in Pre- and Post-lung Transplant Patients
- ClinicalTrials.gov ID
- NCT00205270
- Acronym / sponsor ID
- H-2004-0240
- Conditions
- Influenza
- Keywords
- Pre or post-lung transplant, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 126 participants (actual)
- Lead sponsor
- University of Wisconsin, MadisonUniversity, hospital or other
- Study start
- Dec 2004
- Primary completion
- Jul 2009 (actual)
- Study completion
- Jul 2009 (actual)
- First posted
- 20 Sep 2005 (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.
This 5-year study was designed to investigate how antibody and T cell responses following influenza vaccine compare among lung transplant patients, patients waiting for lung transplantation, and healthy individuals.
Detailed description
[Note: there are 6 ClinicalTrials.gov records associated with this study, each representing a different sub-study of the population over the 5-year period, please see NCT04533061, NCT04533139, NCT04531787, NCT04530786, and NCT04531657 for related data]
Although pre-transplant immunization is routinely recommended, this recommendation is based on little data. The primary objective of this study is to compare antibody responses in lung transplant patients who receive influenza vaccine before transplant, within the first six months of transplant, between 13 and 60 months post-transplant, and 110 months or beyond transplant.
This prospective cohort study is to include immunization events performed over five years to measure H1N1, H3N2, and B antibody responses to the influenza vaccine in pre- and post-lung transplant patients. The pre-transplant patients will move to the post-transplant group as the study progressed. Similarly, participants are allowed to move to the next time-since-transplant group as time elapsed.
Serum was collected from participants prior to and two-four weeks following trivalent inactivated influenza immunization for each season.
Geometric mean titers, seroprotection (antibody titer at least 1:40), seroconversion (fourfold increase between pre and post), and mean fold increases will be compared.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Pre-transplant Vaccine | – | Drug: Influenza vaccineCohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually. |
| 0-6 Months Post-transplant Vaccine | – | Drug: Influenza vaccineCohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 0-6 months post transplant. |
| 13-60 months Post-transplant Vaccine | – | Drug: Influenza vaccineCohort consist of individuals who have received lung transplants and received inactivated influenza vaccine 13-60 months post transplant. |
| Greater than 110 months Post-transplant Vaccine | – | Drug: Influenza vaccineCohort consist of individuals who have received lung transplants and received inactivated influenza vaccine greater than 110 months post transplant. |
| Healthy Controls | – | Drug: Influenza vaccineHealthy controls to measure normal immune response to the influenza vaccine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults and patients receiving care pre- or post-lung transplant at University of Wisconsin Hospital
Key inclusion criteria (2 listed)
- Receiving care pre- or post-lung transplant at University of Wisconsin Hospital
- Healthy adult
Key exclusion criteria (4 listed)
- Allergy to eggs
- Moderate to severe febrile illness
- Active treatment for acute rejection
- Received season's influenza vaccine prior to enrollment
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 vaccineinfluenza vaccine 0.5 ml intramuscularly each season | Drug | 0-6 Months Post-transplant Vaccine, 13-60 months Post-transplant Vaccine, Greater than 110 months Post-transplant Vaccine, Healthy Controls, Pre-transplant Vaccine |
Primary outcome
Antibody response to influenza vaccine
Time frame: Each season
1 secondary outcome
T cell response to influenza vaccine antigens
Time frame: Each season for the first two seasons
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 23 Oct 2020.
- Results publication: PubMed 19588665Dopp JM, Wiegert NA, Moran JJ, Francois ML, Radford KL, Thomas H, Love RB, Hayney MS. Effect of annual influenza immunization on antibody response in lung transplant patients. Prog Transplant. 2009 Jun;19(2):153-9. doi: 10.1177/152692480901900209.
- Results publication: PubMed 18420314Hayney MS, Moran J, Wiegert NA, Burlingham WJ. Lung transplant patients' T cell responses to influenza vaccine viruses between seasons. Vaccine. 2008 May 19;26(21):2596-600. doi: 10.1016/j.vaccine.2008.03.012. Epub 2008 Mar 31.
- Results publication: PubMed 21615847Moran JJ, Rose WE, Darga AJ, Rohde KA, Hayney MS. Persistence of influenza vaccine-induced antibodies in lung transplant patients between seasons. Transpl Infect Dis. 2011 Oct;13(5):466-70. doi: 10.1111/j.1399-3062.2011.00654.x. Epub 2011 May 27.
- Results publication: PubMed 22906937Severson JJ, Richards KR, Moran JJ, Hayney MS. Persistence of influenza vaccine-induced antibody in lung transplant patients and healthy individuals beyond the season. Hum Vaccin Immunother. 2012 Dec 1;8(12):1850-3. doi: 10.4161/hv.21735. Epub 2012 Aug 21.
- Results publication: PubMed 25148380Long AJ, Worzella SL, Moran JJ, Hayney MS. Influenza vaccine antibody response and 6-month persistence in lung transplant recipients using two definitions of seroprotection. Transplantation. 2015 Apr;99(4):885-9. doi: 10.1097/TP.0000000000000391.
- Results publication: PubMed 26928266Miller RM, Rohde KA, Tingle MT, Moran JJ, Hayney MS. Antibody responses to influenza vaccine in pre- and post-lung transplant patients. Clin Transplant. 2016 May;30(5):606-12. doi: 10.1111/ctr.12726. Epub 2016 Mar 20.
- Individual participant dataSharing planned: No
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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.
Mary S Hayney, PharmD principal investigator
University of Wisconsin, Madison
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 Influenza, run by University of Wisconsin, Madison 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 2 inclusion and 4 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 23 Oct 2020. 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?
Antibody response to influenza vaccine (time frame: Each season). 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 NCT00205270, which also lists 6 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 23 Oct 2020.