Clinical trial NCT01685372: Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults
Official title: Immunogenicity and Efficacy of High-dose Trivalent Inactivated Seasonal Influenza Vaccine (Fluzone High Dose) in Immunocompromised Children and Young Adults.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Solid Organ Transplant Recipient (Liver, Kidney, Heart)
Rheumatologic Disorder
Human Immunodeficiency Virus (HIV)
Bone Marrow Transplant (BMT)
Dialysis
Lead sponsor: University of Colorado, Denver
Sponsor class: OTHER
Collaborators: name: Colorado Clinical & Translational Sciences Institute
First posted: 2012-09-14
Enrollment: 16
Sex: ALL
Minimum age (years): 5
Maximum age (years): 35
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief 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.


Eligibility criteria: Inclusion Criteria:

* 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
* 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

Exclusion Criteria:

* 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
* 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.

Primary outcomes:
measure: Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups
timeFrame: up to 10 months after vaccination
measure: Number of Subjects Seroprotected at Timepoint 2 in High Dose and Standard Dose Vaccination Groups
timeFrame: blood draw at 10-45 days post-vaccination
Secondary outcomes:
measure: Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination
timeFrame: 0-14 days after vaccination
measure: Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups
timeFrame: 10-45 days post-vaccination
measure: Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups
timeFrame: at least 5 months post vaccination
measure: Change in Disease Status From Vaccination Through June of the Following Year
timeFrame: up to 9 months post-vaccination
measure: Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination.
timeFrame: (1) Date of vaccine through day 30 post-vaccine; (2) Day 31 post-vaccine through September 30 of the year following vaccine
Other outcomes:
measure: Additional Measures of Immunogenicity in High Dose and Standard Dose Vaccinations
timeFrame: 10-45 days post-vaccination
measure: Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination
timeFrame: (1) T2 measured 14-45 days post-vaccination; (2) T3 measured June 1-Sept 30 post-vaccination (end-of season), following vaccination
Locations:
city: Aurora
country: United States
facility: Children's Hospital Colorado
state: Colorado
Study officials:
affiliation: Children's Hospital Colorado, University of Colorado Denver School of Medicine
name: Donna Curtis, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References: