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Atopic Dermatitis Research Network (ADRN) Influenza Vaccine Pilot

NCT01518478 · Status: COMPLETED · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2017-03-01

No results posted yet for this study

Summary

A new flu vaccine which is injected into the skin instead of into the muscle has recently been approved by the Food and Drug Administration for vaccination of the general population including patients with atopic dermatitis (AD). This new vaccine has been shown to work as well as the vaccine which is injected into muscle when tested in people without atopic dermatitis. The primary endpoint of the study is to estimate the variance of the log fold change from baseline in HAI antibody titers for non-atopic controls and participants with atopic dermatitis without a history of eczema herpeticum (ADEH-), following administration of a single dose of the seasonal 2011-2012 Fluzone® Intradermal vaccine.

Conditions

Interventions

DRUG

Fluzone® Intradermal (Sanofi Pasteur Inc.)

Fluzone® Intradermal trivalent vaccine is a clear-to-slightly opalescent, preservative-free suspension containing formaldehyde-inactivated "split" influenza viruses for intradermal delivery of 0.1 mL via an ultra-fine micro-needle. The vaccine is supplied as a single-dose, in a latex-free, pre-filled microinjection system. The active substance is prepared from influenza viruses propagated in embryonated chicken eggs. Fluzone® Intradermal is standardized according to United States Public Health Service (US PHS) requirements and is formulated to contain HA of each of the following three influenza strains recommended for the 2011-2012 influenza season: A/California/07/2009 X-179A (H1N1)-like virus, A/Perth/16/2009 (H3N2)-like virus, and B/Brisbane/60/2008-like virus.

Sponsors & Collaborators

  • Atopic Dermatitis Research Network

    collaborator OTHER

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Donald Leung, MD, PhD · National Jewish Health

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2011-11-30
Primary Completion
2012-02-29
Completion
2012-03-31

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01518478 on ClinicalTrials.gov