Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults
|ClinicalTrials.gov Identifier: NCT01685372|
Recruitment Status : Completed
First Posted : September 14, 2012
Results First Posted : November 30, 2017
Last Update Posted : January 23, 2018
|Condition or disease||Intervention/treatment||Phase|
|Solid Organ Transplant Recipient (Liver, Kidney, Heart) Rheumatologic Disorder Human Immunodeficiency Virus (HIV) Bone Marrow Transplant (BMT) Dialysis||Biological: Fluzone High Dose Biological: Fluzone||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||16 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Triple (Participant, Care Provider, Investigator)|
|Official Title:||Immunogenicity and Efficacy of High-dose Trivalent Inactivated Seasonal Influenza Vaccine (Fluzone High Dose) in Immunocompromised Children and Young Adults.|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||September 2015|
|Actual Study Completion Date :||September 2017|
Experimental: Fluzone High Dose
Fluzone High Dose 0.5 mL intramuscularly (IM) given once
Biological: Fluzone High Dose
A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm
Active Comparator: Fluzone
Fluzone 0.5mL IM given once
A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm
Other Name: influenza vaccine
- 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:
- 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.]
- 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..
- 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 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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. [ Time Frame: (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
- 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.
- Additional Measures of Immunogenicity in High Dose and Standard Dose Vaccinations [ Time Frame: 10-45 days post-vaccination ]This secondary objective was included as exploratory and we plan to add additional analyses when funding is secured. There is no anticipated date when we will have this completed. (No immunogenicity studies have been done besides HAI.) For other immunogenicity: would compare results of blood draw #1 and #2 between the high-dose and standard-dose recipients for each patient group for any of the following: antibody avidity, microneutralization, T-cell interferon, T-cell IL-2, B-cell Immunoglobulin G (IgG) and B-cell Immunoglobulin A (IgA).
- Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After Vaccination [ Time Frame: (1) T2 measured 14-45 days post-vaccination; (2) T3 measured June 1-Sept 30 post-vaccination (end-of season), following vaccination ]Seroprotection (HAI>=1:40) and seroconversion (4-fold increase) together have been found to be a better predictor of vaccine effectiveness. Patients had to have both a 4-fold rise in HAI and have HAI>=40 to be counted
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01685372
|United States, Colorado|
|Children's Hospital Colorado|
|Aurora, Colorado, United States, 80045|
|Principal Investigator:||Donna Curtis, MD, MPH||Children's Hospital Colorado, University of Colorado Denver School of Medicine|