Immunogenicity of Fluzone High Dose in Immunocompromised Children and Young Adults

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• Acquired Immunodeficiency Syndrome 2,040
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• Rheumatic Diseases 377
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Acquired Immunodeficiency Syndrome

2,040 studies on the registry are indexed under Acquired Immunodeficiency Syndrome; 272 are open to participants now.

This study's enrollment of 16 is below the median of 105 across 1,543 interventional studies indexed under Acquired Immunodeficiency Syndrome.

Lead sponsor

University of Colorado, Denver is the lead sponsor of 1,499 studies on the registry; 315 are open to participants now.

Of its 139 completed or terminated interventional studies of FDA-regulated products, 89 (64%) have results posted.

Study arms

• Experimental
  Fluzone High Dose

  Fluzone High Dose 0.5 mL intramuscularly (IM) given once

  Biological: Fluzone High Dose

• Active comparator
  Fluzone

  Fluzone 0.5mL IM given once

  Biological: Fluzone

Interventions

• BiologicalFluzone High Dose

  A single-dose of high-dose influenza vaccine will be administered to subjects randomized to this arm

  Also known as: high-dose influenza vaccine, influenza vaccine

• BiologicalFluzone

  A single-dose of standard-dose influenza vaccine will be administered to subjects randomized to this arm

  Also known as: influenza vaccine

Primary outcomes

1. 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: 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). \[Centers for Disease Control (CDC) definition of ILI: Fever ≥ 100°F AND cough or sore throat in the absence of another known cause other than influenza for the illness.\]

   Time frame: up to 10 months after vaccination

2. 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..

   Time frame: blood draw at 10-45 days post-vaccination

Secondary outcomes

1. 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.

   Time frame: 0-14 days after vaccination

2. 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.

   Time frame: 10-45 days post-vaccination

3. 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.

   Time frame: at least 5 months post vaccination

4. 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.

   Time frame: up to 9 months post-vaccination

5. Number of Adverse Events Considered Definitely or Possibly Related to Vaccination Through Sept 30 of the Year Following Vaccination.

   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.

   Time frame: (1) Date of vaccine through day 30 post-vaccine; (2) Day 31 post-vaccine through September 30 of the year following vaccine

Other outcomes

1. Additional Measures of Immunogenicity in High Dose and Standard Dose Vaccinations

   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).

   Time frame: 10-45 days post-vaccination

2. Numbers of Subjects Who Were Both Seroprotected and Who Seroconverted at T2 and T3 After 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

   Time frame: (1) T2 measured 14-45 days post-vaccination; (2) T3 measured June 1-Sept 30 post-vaccination (end-of season), following vaccination

Baseline characteristics

Individual participant data

Plan to share: 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.