InfluenzaNCT04533139
Influenza Vaccine in Lung Transplant Patients - Antibody
An observational study of Influenza, run by University of Wisconsin, Madison at 1 site in United States.
Trial summary
This is 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 older
- Conditions the study is for
- Influenza
- What is being tested?
- Influenza vaccine
- Type of treatment
- Vaccines, Injection or infusion
- How many people
- 122 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
- No healthy volunteers
- Adult, Older adult
Study population: Healthy adults, or 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: Effect of Annual Influenza Immunization on Antibody Response in Lung Transplant Patients
This is 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 prospective, parallel study was done to investigate the responses to influenza vaccine in consecutive years.
Read the detailed description
Lung transplant patients may be at an incrementally higher risk of influenza infection than other transplant patients. Factors that predispose them to respiratory infection include high degree of immunosuppression, altered mucociliary clearance, repeated airway instrumentation, bronchial anastomotic obstruction, disruption of lymphatic drainage, and the exposure of the transplanted organ to the environment.
The influenza vaccine used for those at high risk for influenza morbidity and mortality is an inactivated trivalent preparation. Influenza vaccine contains 2 type A viruses and 1 type B virus. The vaccine is reformulated each year based on the viruses expected to circulate during the upcoming season. A protective antibody response to influenza vaccine is considered an antibody titer of at least 1:40. Seroconversion following influenza immunization implies at least a 4-fold increase in antibody concentrations. Although these indicators of a positive response to influenza immunization have significant overlap, they are not exactly the same. One must consider that a person may have antibodies before immunization because of previous exposure to a vaccine virus or an antigenically similar influenza strain.
Seroconversion rates following influenza vaccination are lower in lung transplant patients than in healthy persons. Clearly, immunization elicits an antibody response in this population, but the response is not as vigorous as in immunocompetent persons. It has been demonstrated that only the B/HongKong virus was associated with a lower seroconversion rate, and this virus was the only one to change from the previous year's vaccine. Seroconversion rates decrease with subsequent exposure to the same influenza vaccine viruses, but seroprotection rates remain the same. It is conceivable that the seroconversion response is more affected by immunosuppression than is the seroprotection response. Stated another way, the ability to mount a high spike in antibody production is hindered. It is difficult to fully ascertain the exact degree of immune impairment in lung transplant recipients because both studies investigating influenza vaccine response used healthy persons as the comparison group. Healthy persons may have less experience with influenza vaccine than do persons with severe respiratory conditions. An immunologically naive host is more likely to mount the large change in antibody concentration and increase the likelihood of seroconversion. Therefore, patients waiting for lung transplantation were used as a comparison group.
This prospective, parallel study was done to investigate the responses to influenza vaccine in consecutive years. All participants had a blood sample taken for measurement of influenza antibody titers before receiving the influenza vaccine. Subsequently, the 2004-2005-A/New Caledonia/20/99(H1N1)-like, A/Wyoming/3/2003(H3N2), and B/Shanghai/361/2002-like antigens-and/or 2005-2006-A/New Caledonia/ 20/00(H1N1)-like, A/California/7/2004 (H3N2)-like, and B/Shanghai/361/2002-like antigens-influenza vaccine was administered intramuscularly. Serum was stored at -80°C until the day of analysis. A second blood sample was obtained 2 to 4 weeks later to measure antibody response.
[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
- 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
2004-2005 season antigens: A/New Caledonia/20/99(H1N1)-like, A/Wyoming/3/2003(H3N2), and B/Shanghai/361/2002-like antigens
2005-2006 season antigens: A/New Caledonia/ 20/00(H1N1)-like, A/California/7/2004 (H3N2)-like, and B/Shanghai/361/2002-like antigens
| Study group | Role | What they receive |
|---|---|---|
| Vaccine, pre-transplant | cohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually. Receives: Drug: Influenza vaccine | |
| 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, not receiving transplant | 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.
Log-transformed change in Antibody Responses
Influenza antibody concentrations are measured by HIA in samples taken before immunization and 2 to 4 weeks later. Antibody response is the difference in serum concentrations from before and 2 to 4 weeks after vaccination. Antibody concentrations were compared between seasons by using a Wilcoxon rank sum test.
Measured: baseline, 2-4 weeks post-vaccination (2004-2005 season), up to 1 year, up to 1 year and 4 weeks (2005-2006 season)
Secondary outcomes (3)
Incidence of Seroconversion
Seroconversion was defined as more than a 4-fold increase in serum hemagglutination units (HAU).
Measured: 2-4 weeks post-vaccination (2004-2005 season), up to 1 year and 4 weeks (post-vaccination 2005-2006 season)
Incidence of Seroprotection
Seroprotection was defined as an antibody concentration of 40 HAU or greater.
Measured: baseline, 2-4 weeks post-vaccination (2004-2005 season), up to 1 year, up to 1 year and 4 weeks (2005-2006 season)
Correlation of Time Since Transplantation to Antibody Response in Lung Transplant Patients
Time since transplant was correlated to antibody responses in the transplant subjects by using a Spearman correlation coefficient to determine the influence of chronic immunosuppression on immune responses. Statistical significance was defined as P less than .05.
Measured: 2-4 weeks post-vaccination (2004-2005 season), up to 1 year and 4 weeks (post-vaccination 2005-2006 season)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 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
- 122 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
- NCT04533139
- Sponsor's protocol ID
- H-2004-0240b
- 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
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 19588665
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
- Effect of Annual Influenza Immunization on Antibody Response in Lung Transplant Patients
- ClinicalTrials.gov ID
- NCT04533139
- Acronym / sponsor ID
- H-2004-0240b
- Conditions
- Influenza
- Keywords
- Pre or post-lung transplant, Healthy
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 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
- 31 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 is 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 prospective, parallel study was done to investigate the responses to influenza vaccine in consecutive years.
Detailed description
Lung transplant patients may be at an incrementally higher risk of influenza infection than other transplant patients. Factors that predispose them to respiratory infection include high degree of immunosuppression, altered mucociliary clearance, repeated airway instrumentation, bronchial anastomotic obstruction, disruption of lymphatic drainage, and the exposure of the transplanted organ to the environment.
The influenza vaccine used for those at high risk for influenza morbidity and mortality is an inactivated trivalent preparation. Influenza vaccine contains 2 type A viruses and 1 type B virus. The vaccine is reformulated each year based on the viruses expected to circulate during the upcoming season. A protective antibody response to influenza vaccine is considered an antibody titer of at least 1:40. Seroconversion following influenza immunization implies at least a 4-fold increase in antibody concentrations. Although these indicators of a positive response to influenza immunization have significant overlap, they are not exactly the same. One must consider that a person may have antibodies before immunization because of previous exposure to a vaccine virus or an antigenically similar influenza strain.
Seroconversion rates following influenza vaccination are lower in lung transplant patients than in healthy persons. Clearly, immunization elicits an antibody response in this population, but the response is not as vigorous as in immunocompetent persons. It has been demonstrated that only the B/HongKong virus was associated with a lower seroconversion rate, and this virus was the only one to change from the previous year's vaccine. Seroconversion rates decrease with subsequent exposure to the same influenza vaccine viruses, but seroprotection rates remain the same. It is conceivable that the seroconversion response is more affected by immunosuppression than is the seroprotection response. Stated another way, the ability to mount a high spike in antibody production is hindered. It is difficult to fully ascertain the exact degree of immune impairment in lung transplant recipients because both studies investigating influenza vaccine response used healthy persons as the comparison group. Healthy persons may have less experience with influenza vaccine than do persons with severe respiratory conditions. An immunologically naive host is more likely to mount the large change in antibody concentration and increase the likelihood of seroconversion. Therefore, patients waiting for lung transplantation were used as a comparison group.
This prospective, parallel study was done to investigate the responses to influenza vaccine in consecutive years. All participants had a blood sample taken for measurement of influenza antibody titers before receiving the influenza vaccine. Subsequently, the 2004-2005-A/New Caledonia/20/99(H1N1)-like, A/Wyoming/3/2003(H3N2), and B/Shanghai/361/2002-like antigens-and/or 2005-2006-A/New Caledonia/ 20/00(H1N1)-like, A/California/7/2004 (H3N2)-like, and B/Shanghai/361/2002-like antigens-influenza vaccine was administered intramuscularly. Serum was stored at -80°C until the day of analysis. A second blood sample was obtained 2 to 4 weeks later to measure antibody response.
[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
- 3
| Arm | Type | Receives |
|---|---|---|
| Vaccine, pre-transplant | – | Drug: Influenza vaccinecohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually. |
| Vaccine, post-transplant | – | Drug: Influenza vaccineCohort consist of individuals who have received lung transplants Inactivated influenza vaccine will be administered intramuscularly annually. |
| Vaccine, not receiving transplant | – | 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
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adults, or 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 2004-2005 season antigens: A/New Caledonia/20/99(H1N1)-like, A/Wyoming/3/2003(H3N2), and B/Shanghai/361/2002-like antigens 2005-2006 season antigens: A/New Caledonia/ 20/00(H1N1)-like, A/California/7/2004 (H3N2)-like, and B/Shanghai/361/2002-like antigens | Drug | Vaccine, not receiving transplant, Vaccine, post-transplant, Vaccine, pre-transplant |
Primary outcome
Log-transformed change in Antibody Responses
Time frame: baseline, 2-4 weeks post-vaccination (2004-2005 season), up to 1 year, up to 1 year and 4 weeks (2005-2006 season)
Influenza antibody concentrations are measured by HIA in samples taken before immunization and 2 to 4 weeks later. Antibody response is the difference in serum concentrations from before and 2 to 4 weeks after vaccination. Antibody concentrations were compared between seasons by using a Wilcoxon rank sum test.
3 secondary outcomes
Incidence of Seroconversion
Time frame: 2-4 weeks post-vaccination (2004-2005 season), up to 1 year and 4 weeks (post-vaccination 2005-2006 season)
Incidence of Seroprotection
Time frame: baseline, 2-4 weeks post-vaccination (2004-2005 season), up to 1 year, up to 1 year and 4 weeks (2005-2006 season)
Correlation of Time Since Transplantation to Antibody Response in Lung Transplant Patients
Time frame: 2-4 weeks post-vaccination (2004-2005 season), up to 1 year and 4 weeks (post-vaccination 2005-2006 season)
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.
- 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?
Log-transformed change in Antibody Responses (time frame: baseline, 2-4 weeks post-vaccination (2004-2005 season), up to 1 year, up to 1 year and 4 weeks (2005-2006 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 NCT04533139, 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.