Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults

Phase 2

Completed

Conditions: Solid Organ Transplant Recipient (Liver, Kidney, Heart)
Rheumatologic Disorder
Human Immunodeficiency Virus (HIV)
Bone Marrow Transplant (BMT)
Dialysis

Interventions: Biological: Fluzone High Dose
Biological: Fluzone

Registration Number: NCT01685372

Lead Sponsor: University of Colorado, Denver

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.

Detailed Description: Not available

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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.

Study Type: INTERVENTIONAL

Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Fluzone High Dose	Fluzone High Dose	Fluzone High Dose 0.5 mL intramuscularly (IM) given once
Fluzone	Fluzone	Fluzone 0.5mL IM given once

Primary Outcome Measures

Name	Time	Method
Number of Episodes of Influenza and Influenza-Like-Illness Reported in High Dose and Standard Dose Vaccination Groups	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	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..

Secondary Outcome Measures

Name	Time	Method
Number of Adverse Events Definitely or Possibly Related to Vaccination Reported Within 14 Days of Vaccination	0-14 days after 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.
Number of Subjects With Seroconversion From T1 to T2 in the High Dose and Standard Dose Vaccine Groups	10-45 days post-vaccination	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.
Number of Participants Seroprotected at Timepoint 3 in High Dose and Standard Dose Vaccination Groups	at least 5 months post vaccination	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.
Change in Disease Status From Vaccination Through June of the Following Year	up to 9 months post-vaccination	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.
Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination.	(1) Date of vaccine through day 30 post-vaccine; (2) Day 31 post-vaccine through September 30 of the year following vaccine	Data gathered from the following 1. Safety data in 1st 14 days (safety surveys and safety diary) 2. Safety survey at day 30-45 regarding any unplanned health care visit or other AE during the 30 days after vaccine 3. On-going passive surveillance of adverse events (AEs)/serious adverse events (SAEs) throughout course of influenza season of enrollment 4. Chart review of each participant by PI through Sept 30 of the year following vaccine Data collection stopped in September following enrollment.

Trial Locations

Locations (1): Children's Hospital Colorado
🇺🇸
Aurora, Colorado, United States

Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults

Recruitment & Eligibility

Study & Design

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