InfluenzaNCT04530786
Influenza Vaccine in Lung Transplant Patients - Persistence of Antibodies Beyond the Season
An observational study of Influenza, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This a sub-study of a 5-year study 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
- 100 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 adult or patient receiving care post-lung transplant at the University of Wisconsin Hospital
Who may be able to join
- Receiving care 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: Persistence of Influenza Vaccine-induced Antibody in Lung Transplant Patients and Healthy Individuals Beyond the Season
This a sub-study of a 5-year study 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.
This study is designed to investigate influenza vaccine-induced antibodies in lung transplant patients beyond the season of vaccination.
Read the detailed description
Every year influenza infection causes significant morbidity and mortality in the general population making it a serious public health concern. Among those at highest risk for complications from infection are the immunocompromised. Effective influenza immunization that confers protection throughout the season is critical for lung transplant recipients because in addition to aggressive immunosuppressive therapy, infection directly affects the transplanted organ. Studies of influenza vaccine response rates in lung transplant patients show generally lower antibody concentrations, but acceptable influenza vaccine response rates compared with healthy individuals. However, little is known about the persistence of influenza vaccine-induced antibody concentration in either healthy or immunosuppressed populations.
Influenza antibody concentrations persist at seroprotective levels (defined as antibody concentrations at least 40 hemagglutination units) up to a year post vaccination. However, the investigators could find no information regarding persistence beyond one year.
It is hypothesized that the high rates of persisting influenza vaccine antibody in immunosuppressed lung transplant individuals would match the rates of persisting vaccine-antibody in healthy individuals.
Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually (individual participants followed for 3 years). Samples were collected at 2-4 weeks post-vaccination. Seroprotection was defined as a titer of ≥ 1:40 and was compared between groups over the measured term using Fisher's exact tests.
[This substudy that was originally registered to NCT00205270 and subsequently registered to its own NCT number for the purpose of clarity in linked results]
- Conditions
- Influenza
- Being tested
- Influenza vaccine
- Keywords
- post-lung transplant, Healthy, immunocompromised
- 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, antigens measured for 3 years following vaccination in:
- 2004-2005: A/Wyoming H3N2; B/Shanghai
- 2006-2007: A/New Caledonia H1N1
- 2007-2008: A/Solomon Islands; A/Wisconsin H3N2; B/Malaysia
| Study group | Role | What they receive |
|---|---|---|
| Vaccine, Post-transplant | Cohort consist of individuals who have received lung transplants Inactivated influenza vaccine will be administered intramuscularly annually. Receives: Drug: Influenza vaccine | |
| Vaccine, Healthy Control | Cohort consists of healthy individuals who received the influenza vaccine Inactivated influenza vaccine will be administered intramuscularly annually. 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
Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.
Measured: season 1 (up to 1 year on study)
Antibody response to influenza vaccine
Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.
Measured: season 2 (up to 2 years on study)
Antibody response to influenza vaccine
Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.
Measured: season 2 (up to 2.5 years on study)
Antibody response to influenza vaccine
Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.
Measured: season 3 (up to 3 years on study)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2020
- 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 (1)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
- 100 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
- NCT04530786
- Sponsor's protocol ID
- H-2004-0240d
- Other IDs
- A561000, PHARM/PHARMACY/PHARMACY
- Status last verified
- Oct 2020
- First submitted
- 25 Aug 2020
- 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
Severson 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 22906937
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
- Persistence of Influenza Vaccine-induced Antibody in Lung Transplant Patients and Healthy Individuals Beyond the Season
- ClinicalTrials.gov ID
- NCT04530786
- Acronym / sponsor ID
- H-2004-0240d
- Conditions
- Influenza
- Keywords
- post-lung transplant, Healthy, immunocompromised
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 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
- 28 Aug 2020 (actual)
- 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 a sub-study of a 5-year study 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.
This study is designed to investigate influenza vaccine-induced antibodies in lung transplant patients beyond the season of vaccination.
Detailed description
Every year influenza infection causes significant morbidity and mortality in the general population making it a serious public health concern. Among those at highest risk for complications from infection are the immunocompromised. Effective influenza immunization that confers protection throughout the season is critical for lung transplant recipients because in addition to aggressive immunosuppressive therapy, infection directly affects the transplanted organ. Studies of influenza vaccine response rates in lung transplant patients show generally lower antibody concentrations, but acceptable influenza vaccine response rates compared with healthy individuals. However, little is known about the persistence of influenza vaccine-induced antibody concentration in either healthy or immunosuppressed populations.
Influenza antibody concentrations persist at seroprotective levels (defined as antibody concentrations at least 40 hemagglutination units) up to a year post vaccination. However, the investigators could find no information regarding persistence beyond one year.
It is hypothesized that the high rates of persisting influenza vaccine antibody in immunosuppressed lung transplant individuals would match the rates of persisting vaccine-antibody in healthy individuals.
Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually (individual participants followed for 3 years). Samples were collected at 2-4 weeks post-vaccination. Seroprotection was defined as a titer of ≥ 1:40 and was compared between groups over the measured term using Fisher's exact tests.
[This substudy that was originally registered to NCT00205270 and subsequently registered to its own NCT number for the purpose of clarity in linked results]
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Vaccine, Post-transplant | – | Drug: Influenza vaccineCohort consist of individuals who have received lung transplants Inactivated influenza vaccine will be administered intramuscularly annually. |
| Vaccine, Healthy Control | – | Drug: Influenza vaccineCohort consists of healthy individuals who received the influenza vaccine Inactivated influenza vaccine will be administered intramuscularly annually. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult or patient receiving care post-lung transplant at the University of Wisconsin Hospital
Key inclusion criteria (2 listed)
- Receiving care 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, antigens measured for 3 years following vaccination in: * 2004-2005: A/Wyoming H3N2; B/Shanghai * 2006-2007: A/New Caledonia H1N1 * 2007-2008: A/Solomon Islands; A/Wisconsin H3N2; B/Malaysia | Drug | Vaccine, Healthy Control, Vaccine, Post-transplant |
Primary outcome
Antibody response to influenza vaccine
Time frame: season 1 (up to 1 year on study)
Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.
Antibody response to influenza vaccine
Time frame: season 2 (up to 2 years on study)
Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.
Antibody response to influenza vaccine
Time frame: season 2 (up to 2.5 years on study)
Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.
Antibody response to influenza vaccine
Time frame: season 3 (up to 3 years on study)
Influenza antibody concentrations against viruses no longer included in the vaccine were measured in serum by hemagglutination inhibition assay (HIA) annually following vaccination of lung transplant participants and healthy controls.
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 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.
- 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: season 1 (up to 1 year on study)). The study lists 4 primary outcomes in all. 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 NCT04530786, which also lists 1 linked publication.
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.