Solid Organ Transplant Recipient (Liver, Kidney, Heart)Phase 2NCT01685372
Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults
A Phase 2 study testing Fluzone High Dose and Fluzone in people with Solid Organ Transplant Recipient (Liver, Kidney, Heart) and Rheumatologic Disorder, run by University of Colorado, Denver at 1 site in United States.
Trial summary
The purpose of this study is to determine whether Fluzone High Dose increases the immune response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone in immunocompromised children and young adults. Safety and efficacy data will also be collected. Read more about this study
- Who is it for?
- Ages 5 to 35 years
- Conditions the study is for
- Solid Organ Transplant Recipient (Liver, Kidney, Heart), Rheumatologic Disorder, Human Immunodeficiency Virus (HIV)
- What is being tested?
- Fluzone High Dose and Fluzone
- Type of treatment
- Vaccines, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteUnited States
- Study dates
- Sep 2012to Sep 2017
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 5 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age ≥ 5 years and ≤ 35 years
- Receiving influenza vaccination in Children's Hospital Colorado (CHC) clinic as part of routine clinical care
- Only supposed to receive one dose of influenza vaccine
- Rheumatology patients: must be on some type of immunosuppressive or immunomodulatory medication at the time of immunization and considered at least moderately immunosuppressed in the opinion of the primary rheumatologist. Basic guidelines for rheumatology patients: (1) Any patient receiving monoclonal antibody therapy (i.e., infliximab, etanercept, tocilizumab, anakinra) must also be taking another immunosuppressive/immunomodulatory medication; (2) Patients taking steroids as monotherapy must be on a dose of ≥ 2mg/kg/day OR ≥ 20mg/day; (3) Patients on combination therapy where the dose of a single drug may not be very high, but the combination is considered moderately or severely immunosuppressive will be eligible.
- Bone Marrow Transplant patients: all patients in clinic eligible
- Oncology patients: must be on some type of chemotherapy
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- Hemodialysis patients: must be on dialysis
- Child Health Immunodeficiency Program (CHIP) patients: must have a known diagnosis of HIV
- Solid Organ Transplant patients: post-transplant, influenza vaccine recommended by primary transplant physician
Who cannot join
- Rheumatology patients: if receiving any of the monoclonal antibodies, etanercept, infliximab, adalimumab, tocilizumab, atlizumab, or anakinra, must also be taking at least one other immunosuppressive/immunomodulatory medication
- Unable to come for scheduled follow-up appointments
- History of anaphylaxis reaction to influenza vaccination in the past
- Severe allergic reaction to any component of the vaccine, including egg protein, or after previous dose of any influenza vaccine
- History of Guillain-Barre syndrome ever in the past in the subject or in a parent or a sibling of the subject
- Allergy to latex
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- Intravenous immuneglobulin (IVIG) within in 4 weeks preceding any blood draw
- Receiving an investigational agent as part of another study or other medical treatment (investigational = not-FDA approved for any indication)
- Subject not enrolled in other studies that prohibit him/her from enrolling in this study
- Blood draw contraindicated
- Pregnancy
- Breastfeeding
- Received a polysaccharide vaccine (pneumovax) w/in 3 weeks of the vaccination
- Absolute neutrophil count (ANC) < 500/uL at the time of vaccination or could potentially have ANC 500/uL during the 5 days after vaccination
- Platelet count < 50,000/uL at the time of vaccination
- If a subject has a temperature ≥ 100.4°F at the time of enrollment, then the subject must choose to not enroll or delay immunization until afebrile.
- Receiving influenza vaccination past December 15 of influenza season.
Trial locations and contacts
1 site in 1 country.
United States1 site
Children's Hospital Colorado
Aurora, Colorado, 80045
About this study
Official title: Immunogenicity and Efficacy of High-dose Trivalent Inactivated Seasonal Influenza Vaccine (Fluzone High Dose) in Immunocompromised Children and Young Adults.
The purpose of this study is to determine whether Fluzone High Dose increases the immune response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone in immunocompromised children and young adults. Safety and efficacy data will also be collected.
- Conditions
- Solid Organ Transplant Recipient (Liver, Kidney, Heart), Rheumatologic Disorder, Human Immunodeficiency Virus (HIV), Bone Marrow Transplant (BMT), Dialysis
- Being tested
- Fluzone High Dose, Fluzone
- Medical subject headings
- Collagen Diseases, Acquired Immunodeficiency Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluzone High DoseBiological
Also called high-dose influenza vaccine, influenza vaccine
A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
FluzoneBiological
Also called influenza vaccine
A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
| Study group | Role | What they receive |
|---|---|---|
| Fluzone High Dose | Experimental | Fluzone High Dose 0.5 mL intramuscularly (IM) given once Receives: Biological: Fluzone High Dose |
| Fluzone | Active comparator | Fluzone 0.5mL IM given once Receives: Biological: Fluzone |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups
Gathered data on influenza and influenza-like-illness during the influenza season for which the subject was vaccinated. Reported numbers of episodes of PCR-diagnosed influenza and rates of reported Influenza-Like-Illness (ILI) from Questionnaire #2 and also that were obtained from medical records. Data were categorized by the following:
- Polymerase chain reaction (PCR)-proven diagnosis of influenza performed at Children's Hospital Colorado (CHC)
- Diagnosis of influenza by non-PCR rapid-influenza test
- Diagnosis of ILI (from questionnaire #2). [Centers for Disease Control (CDC) definition of ILI: Fever ≥ 100°F AND cough or sore throat in the absence of another known cause other than influenza for the illness.]
Measured: up to 10 months after vaccination
Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups
Measure hemagglutinin inhibition (HAI) on blood samples #2 for all subjects, which is the sample drawn at the "peak" of the immune response. Compare number of subjects who are seroprotected (reaching HAI ≥ 1:40) between the high-dose and standard-dose recipients..
Measured: blood draw at 10-45 days post-vaccination
Secondary outcomes (5)
Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination
Number of adverse events reported within the 14 days after vaccination by each subject within each patient group. Data collected from that reported in safety questionnaires and in Safety Diary that spanned the 14 days post-vaccination.
Measured: 0-14 days after vaccination
Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups
HAI was measured on blood samples #1 and #2 for all subjects. Seroconversion is defined as a four-fold increase in antibody level between the high-dose and standard-dose recipients within each patient group was performed.
Measured: 10-45 days post-vaccination
Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups
Measure HAI on blood sample #3, drawn May-September following vaccination. Report number who still have HAI ≥ 1:40 in the high-dose and standard-dose groups.
Measured: at least 5 months post vaccination
Change in Disease Status From Vaccination Through June of the Following Year
Evaluate disease status changes reported by subject on Questionnaire #2 as well as changes reported in clinic notes over the course of the influenza season. Subjects considered "worse" had worsening function of transplanted organ or complications related to underlying condition (e.g. dialysis) or new diagnosis of disease considered serious by PI.
Measured: up to 9 months post-vaccination
Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination.
Data gathered from the following
- Safety data in 1st 14 days (safety surveys and safety diary)
- Safety survey at day 30-45 regarding any unplanned health care visit or other AE during the 30 days after vaccine
- On-going passive surveillance of adverse events (AEs)/serious adverse events (SAEs) throughout course of influenza season of enrollment
- Chart review of each participant by PI through Sept 30 of the year following vaccine Data collection stopped in September following enrollment.
Measured: (1) Date of vaccine through day 30 post-vaccine; (2) Day 31 post-vaccine through September 30 of the year following vaccine
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2012 (estimated)
- Study startSep 2012
- Primary completionSep 2015
- Study completionSep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Solid Organ Transplant Recipient (Liver, Kidney, Heart)Studies of the same condition, open and under way.
- More trials run by University of Colorado, DenverThe 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Colorado, Denver
- Sponsor type
- University, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute
- Responsible party
- Sponsor
- Investigators
- Donna Curtis, MD, MPH, Principal investigator, Children's Hospital Colorado, University of Colorado Denver School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01685372
- Sponsor's protocol ID
- 12-0829
- Status last verified
- Dec 2017
- First submitted
- 27 Aug 2012
- Last updated
- 23 Jan 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No: There is no plan to share data at the end of the study. Data management at the close of the study will occur according to IRB and FDA regulations.
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Immunogenicity and Efficacy of High-dose Trivalent Inactivated Seasonal Influenza Vaccine (Fluzone High Dose) in Immunocompromised Children and Young Adults.
- ClinicalTrials.gov ID
- NCT01685372
- Acronym / sponsor ID
- 12-0829
- Conditions
- Solid Organ Transplant Recipient (Liver, Kidney, Heart), Rheumatologic Disorder, Human Immunodeficiency Virus (HIV), Bone Marrow Transplant (BMT), Dialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- University of Colorado, DenverUniversity, hospital or other
- Collaborators
- Colorado Clinical & Translational Sciences Institute
- Study start
- Sep 2012
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2017 (actual)
- First posted
- 14 Sep 2012 (estimated)
- Results
- Posted 30 Nov 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine whether Fluzone High Dose increases the immune response to the influenza antigens contained in the vaccine compared to standard-dose Fluzone in immunocompromised children and young adults. Safety and efficacy data will also be collected.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Fluzone High Dose | Experimental | Biological: Fluzone High DoseFluzone High Dose 0.5 mL intramuscularly (IM) given once |
| Fluzone | Active comparator | Biological: FluzoneFluzone 0.5mL IM given once |
Who may qualify
- Ages
- 5 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (9 listed)
- Age ≥ 5 years and ≤ 35 years
- Receiving influenza vaccination in Children's Hospital Colorado (CHC) clinic as part of routine clinical care
- Only supposed to receive one dose of influenza vaccine
- Rheumatology patients: must be on some type of immunosuppressive or immunomodulatory medication at the time of immunization and considered at least moderately immunosuppressed in the opinion of the primary rheumatologist. Basic guidelines for rheumatology patients: (1) Any patient receiving monoclonal antibody therapy (i.e., infliximab, etanercept, tocilizumab, anakinra) must also be taking another immunosuppressive/immunomodulatory medication; (2) Patients taking steroids as monotherapy must be on a dose of ≥ 2mg/kg/day OR ≥ 20mg/day; (3) Patients on combination therapy where the dose of a single drug may not be very high, but the combination is considered moderately or severely immunosuppressive will be eligible.
- Bone Marrow Transplant patients: all patients in clinic eligible
Key exclusion criteria (17 listed)
- Rheumatology patients: if receiving any of the monoclonal antibodies, etanercept, infliximab, adalimumab, tocilizumab, atlizumab, or anakinra, must also be taking at least one other immunosuppressive/immunomodulatory medication
- Unable to come for scheduled follow-up appointments
- History of anaphylaxis reaction to influenza vaccination in the past
- Severe allergic reaction to any component of the vaccine, including egg protein, or after previous dose of any influenza vaccine
- History of Guillain-Barre syndrome ever in the past in the subject or in a parent or a sibling of the subject
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 |
|---|---|---|
| Fluzone High DoseAlso: high-dose influenza vaccine, influenza vaccineA single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm | Biological | Fluzone High Dose |
| FluzoneAlso: influenza vaccineA single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm | Biological | Fluzone |
Primary outcome
Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups
Time frame: up to 10 months after vaccination
Gathered data on influenza and influenza-like-illness during the influenza season for which the subject was vaccinated. Reported numbers of episodes of PCR-diagnosed influenza and rates of reported Influenza-Like-Illness (ILI) from Questionnaire #2 and also that were obtained from medical records. Data were categorized by the following: 1. Polymerase chain reaction (PCR)-proven diagnosis of influenza performed at Children's Hospital Colorado (CHC) 2. Diagnosis of influenza by non-PCR rapid-influenza test 3. Diagnosis of ILI (from questionnaire #2). [Centers for Disease Control (CDC) definition of ILI: Fever ≥ 100°F AND cough or sore throat in the absence of another known cause other than influenza for the illness.]
Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups
Time frame: blood draw at 10-45 days post-vaccination
Measure hemagglutinin inhibition (HAI) on blood samples #2 for all subjects, which is the sample drawn at the "peak" of the immune response. Compare number of subjects who are seroprotected (reaching HAI ≥ 1:40) between the high-dose and standard-dose recipients..
5 secondary outcomes
Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination
Time frame: 0-14 days after vaccination
Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups
Time frame: 10-45 days post-vaccination
Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups
Time frame: at least 5 months post vaccination
Change in Disease Status From Vaccination Through June of the Following Year
Time frame: up to 9 months post-vaccination
Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination.
Time frame: (1) Date of vaccine through day 30 post-vaccine; (2) Day 31 post-vaccine through September 30 of the year following vaccine
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jan 2018.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. There is no plan to share data at the end of the study. Data management at the close of the study will occur according to IRB and FDA regulations.
Related trials for Solid Organ Transplant Recipient (Liver, Kidney, Heart)
Recruiting
Multidisciplinary Non-Pharmacological Intervention to Improve Quality of Life in Solid Organ Transplant Recipients
Heart Transplant Patients, Kidney Transplant Patients
Not yet recruiting
EASE-SOT Pilot Study
Transplant;Failure,Kidney, Transplant; Failure, Heart
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.
Donna Curtis, MD, MPH principal investigator
Children's Hospital Colorado, University of Colorado Denver School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Fluzone High Dose and Fluzone in people with Solid Organ Transplant Recipient (Liver, Kidney, Heart) and Rheumatologic Disorder, run by University of Colorado, Denver 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 9 inclusion and 17 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 Jan 2018. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 30 Nov 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups (time frame: up to 10 months after vaccination). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Jan 2018.