Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults

University of Colorado Denver (CU Denver)

Status and phase

Completed

Phase 2

Conditions

Rheumatologic Disorder

Dialysis

Human Immunodeficiency Virus (HIV)

Bone Marrow Transplant (BMT)

Solid Organ Transplant Recipient (Liver, Kidney, Heart)

Treatments

Biological: Fluzone High Dose

Biological: Fluzone

Study type

Interventional

Funder types

Other

Identifiers

NCT01685372

12-0829

Details and patient eligibility

About

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.

Enrollment

16 patients

Sex

All

Ages

5 to 35 years old

Volunteers

No Healthy Volunteers

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.