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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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
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.

United States1 site
  • University of Wisconsin

    Madison, Wisconsin, 53792

Other trials in United States

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 groups in NCT04533139
Study groupRoleWhat they receive
Vaccine, pre-transplantcohort consists of individuals waiting for lung transplantation. Inactivated influenza vaccine will be administered intramuscularly annually.
Receives: Drug: Influenza vaccine
Vaccine, post-transplantCohort consist of individuals who have received lung transplants Inactivated influenza vaccine will be administered intramuscularly annually.
Receives: Drug: Influenza vaccine
Vaccine, not receiving transplantCohort 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.

  1. 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)
  1. 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)

  2. 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)

  3. 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.

  1. First posted31 Aug 2020
  2. Study startDec 2004
  3. Primary completionJul 2009
  4. Study completionJul 2009

Resources

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)
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

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.

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