Influenza VirusNCT00760175
Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients
A study testing Vaxigrip (Aventis-Pasteur Canada) in people with Influenza Virus and Influenza Vaccine, run by University of Alberta at 2 sites in 2 countries.
Trial summary
The influenza virus, commonly called the flu, is a common source of infection in lung transplant patients and can often lead to pneumonia and possibly rejection. The annual influenza vaccine is the most important strategy used to prevent infection but it is not effective in all lung transplant patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Influenza Virus, Influenza Vaccine
- What is being tested?
- Vaxigrip (Aventis-Pasteur Canada)
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 85 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2008to Feb 2010
- Phase
- Interventional
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18
- Greater than 3 months post-transplant
- Outpatient status
Who cannot join
- Has already received influenza vaccination for 2008-2009 season
- Egg allergy
- Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome)
- On anticoagulants such as warfarin that precludes intramuscular injection
- Ongoing therapy for rejection
- Febrile illness in the past two weeks
- Unable to provide informed consent
- Unable to comply with study protocol
Trial locations and contacts
2 sites in 2 countries.
2 sites in 2 countries
About this study
Official title: A Randomized, Controlled Trial Comparing Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients
The influenza virus, commonly called the flu, is a common source of infection in lung transplant patients and can often lead to pneumonia and possibly rejection. The annual influenza vaccine is the most important strategy used to prevent infection but it is not effective in all lung transplant patients. It has been thought that the response to the vaccine may be improved if it is given into the skin (intradermal) rather than the muscle (intramuscular). We hypothesize that a significantly greater proportion of patients will respond to vaccination using the intradermal influenza vaccine compared to the intramuscular vaccine.
Read the detailed description
The annual influenza vaccine is suggested for immunocompromised patients. However, the immunogenic response to this vaccine is suboptimal and ranges from 15-70%. In lung transplant recipients, responses to the influenza vaccine are poorest of all organ transplant groups. For example, a study with 43 stable lung transplant recipients showed that protective antibody developed in 19%, 30%, and 40% for the three antigens in the vaccine (only 8.6% of subjects developed protective antibody levels against all three). Similarly, 43% responded after a single dose of vaccine was given to 68 lung transplant recipients; response was significantly lower in those on mycophenolate mofetil (MMF). We have recently published a study in 60 lung transplant recipients where the standard influenza vaccine was immunogenic to at least one vaccine antigen in approximately 60% of the patients.
The study we propose is a prospective randomized control trial designed to assess the immunogenicity of the influenza vaccine given intradermally compared to the standard intramuscular vaccine in lung transplant recipients. Lung transplant recipients are unique in that their vaccine responses are the lowest of all organ groups and they stand to benefit most from an alternate vaccine strategy.
CLINICAL SIGNIFICANCE OF THE STUDY Lung transplant recipients appear to have one of the poorest humoral responses to influenza vaccination of all the organ transplant groups. However, influenza remains an important cause of morbidity in this population in whom protection is imperative. The current vaccine is suboptimal and newer strategies need to be studied to increase response rates. This subject area is of critical importance to study and especially in light of the threat of pandemic influenza.
OBJECTIVE AND HYPOTHESIS
- To test the specific humoral and cellular response after the intradermal influenza vaccine.
- To test the safety of the intradermal influenza vaccine in the lung transplant population.
- We hypothesize that a significantly greater proportion of patients will respond to vaccination using the intradermal influenza vaccine compared to the intramuscular vaccine.
- Conditions
- Influenza Virus, Influenza Vaccine
- Being tested
- Vaxigrip (Aventis-Pasteur Canada)
- Keywords
- Lung transplant Recipients, Vaxigrip
- Medical subject headings
- Influenza, Human
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vaxigrip (Aventis-Pasteur Canada)Biological
Also called Influenza vaccine
The intramuscular dose (0.5 mL contains 15 micrograms antigen from each strain and the intradermal doses (2 x 0.1 mL)contain 6 micrograms antigen from each strain.
| Study group | Role | What they receive |
|---|---|---|
| intradermal | Active comparator | Not described Receives: Biological: Vaxigrip (Aventis-Pasteur Canada) |
| intramuscular | Active comparator | Not described Receives: Biological: Vaxigrip (Aventis-Pasteur Canada) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers Seroprotection rate: HIA titers of >/= 1:40
Measured: 4 weeks
Secondary outcomes (1)
Local and systemic adverse events to vaccination
Measured: 24 hours, 48 hours and 7 days after each vaccination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Sep 2008 (estimated)
- Study startOct 2008
- Primary completionDec 2009
- Study completionFeb 2010
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 Influenza VirusStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 85 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Responsible party
- Sponsor
- Investigators
- Deepali Kumar, Msc, FRCPC, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00760175
- Sponsor's protocol ID
- 7407
- Status last verified
- May 2015
- First submitted
- 25 Sep 2008
- Last updated
- 27 May 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Manuel O, Humar A, Chen MH, Chernenko S, Singer LG, Cobos I, Kumar D. Immunogenicity and safety of an intradermal boosting strategy for vaccination against influenza in lung transplant recipients. Am J Transplant. 2007 Nov;7(11):2567-72. doi: 10.1111/j.1600-6143.2007.01982.x. Epub 2007 Oct 1.
PubMed 17908277
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Controlled Trial Comparing Intradermal Versus Intramuscular Trivalent Influenza Vaccine in Adult Lung Transplant Recipients
- ClinicalTrials.gov ID
- NCT00760175
- Acronym / sponsor ID
- 7407
- Conditions
- Influenza Virus, Influenza Vaccine
- Keywords
- Lung transplant Recipients, Vaxigrip
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 85 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- University of Lausanne Hospitals
- Study start
- Oct 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 26 Sep 2008 (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.
The influenza virus, commonly called the flu, is a common source of infection in lung transplant patients and can often lead to pneumonia and possibly rejection. The annual influenza vaccine is the most important strategy used to prevent infection but it is not effective in all lung transplant patients. It has been thought that the response to the vaccine may be improved if it is given into the skin (intradermal) rather than the muscle (intramuscular). We hypothesize that a significantly greater proportion of patients will respond to vaccination using the intradermal influenza vaccine compared to the intramuscular vaccine.
Detailed description
The annual influenza vaccine is suggested for immunocompromised patients. However, the immunogenic response to this vaccine is suboptimal and ranges from 15-70%. In lung transplant recipients, responses to the influenza vaccine are poorest of all organ transplant groups. For example, a study with 43 stable lung transplant recipients showed that protective antibody developed in 19%, 30%, and 40% for the three antigens in the vaccine (only 8.6% of subjects developed protective antibody levels against all three). Similarly, 43% responded after a single dose of vaccine was given to 68 lung transplant recipients; response was significantly lower in those on mycophenolate mofetil (MMF). We have recently published a study in 60 lung transplant recipients where the standard influenza vaccine was immunogenic to at least one vaccine antigen in approximately 60% of the patients.
The study we propose is a prospective randomized control trial designed to assess the immunogenicity of the influenza vaccine given intradermally compared to the standard intramuscular vaccine in lung transplant recipients. Lung transplant recipients are unique in that their vaccine responses are the lowest of all organ groups and they stand to benefit most from an alternate vaccine strategy.
CLINICAL SIGNIFICANCE OF THE STUDY Lung transplant recipients appear to have one of the poorest humoral responses to influenza vaccination of all the organ transplant groups. However, influenza remains an important cause of morbidity in this population in whom protection is imperative. The current vaccine is suboptimal and newer strategies need to be studied to increase response rates. This subject area is of critical importance to study and especially in light of the threat of pandemic influenza.
OBJECTIVE AND HYPOTHESIS
- To test the specific humoral and cellular response after the intradermal influenza vaccine.
- To test the safety of the intradermal influenza vaccine in the lung transplant population.
- We hypothesize that a significantly greater proportion of patients will respond to vaccination using the intradermal influenza vaccine compared to the intramuscular vaccine.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| intradermal | Active comparator | Biological: Vaxigrip (Aventis-Pasteur Canada) |
| intramuscular | Active comparator | Biological: Vaxigrip (Aventis-Pasteur Canada) |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age ≥ 18
- Greater than 3 months post-transplant
- Outpatient status
Key exclusion criteria (8 listed)
- Has already received influenza vaccination for 2008-2009 season
- Egg allergy
- Previous life-threatening reaction to influenza vaccine (i.e. Guillain Barre Syndrome)
- On anticoagulants such as warfarin that precludes intramuscular injection
- Ongoing therapy for rejection
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 |
|---|---|---|
| Vaxigrip (Aventis-Pasteur Canada)Also: Influenza vaccineThe intramuscular dose (0.5 mL contains 15 micrograms antigen from each strain and the intradermal doses (2 x 0.1 mL)contain 6 micrograms antigen from each strain. | Biological | intradermal, intramuscular |
Primary outcome
Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers Seroprotection rate: HIA titers of >/= 1:40
Time frame: 4 weeks
1 secondary outcome
Local and systemic adverse events to vaccination
Time frame: 24 hours, 48 hours and 7 days after each 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 27 May 2015.
- Results publication: PubMed 17908277Manuel O, Humar A, Chen MH, Chernenko S, Singer LG, Cobos I, Kumar D. Immunogenicity and safety of an intradermal boosting strategy for vaccination against influenza in lung transplant recipients. Am J Transplant. 2007 Nov;7(11):2567-72. doi: 10.1111/j.1600-6143.2007.01982.x. Epub 2007 Oct 1.
- The Centers for Disease Control and Prevention (CDC) and the Canadian National Advisory Committee on Immunization (NACI) currently recommends this vaccine for children \> 6 months, healthy adults, the elderly and all immunocompromised patientsLink provided by the sponsor.
Related trials for Influenza Virus
Enrolling by invitation
Personalized Ventilator Settings for Patients on ECMO
Acute Respiratory Distress Syndrome (ARDS), Extracorporeal Membrane Oxygenation
RecruitingPhase 2
BPL-1357 Against H1N1 Influenza Virus Challenge
Influenza, Human
Not yet recruitingPhase 1
Safety and Immunogenicity of Chimeric Hemagglutinin mRNA Vaccine Candidates
Influenza
RecruitingPhase 1
pH1N1 Blinded Challenge Study
Influenza
RecruitingPhase 3
A Study to Evaluate the Safety and Efficacy of MK-1406/CD388 for Prevention of Influenza (MK-1406-005/CD388.SQ.3.06)
Influenza
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.
Deepali Kumar, Msc, FRCPC principal investigator
University of Alberta
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vaxigrip (Aventis-Pasteur Canada) in people with Influenza Virus and Influenza Vaccine, run by University of Alberta at 2 sites in 2 countries.
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 3 inclusion and 8 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 27 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada, Switzerland. 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?
Seroconversion rate: serological response with a four-fold or greater increase in HI antibody titers Seroprotection rate: HIA titers of >/= 1:40 (time frame: 4 weeks). 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 NCT00760175, 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 27 May 2015.