A clinical trial of intradermal and intramuscular seasonal influenza vaccination in patients with atopic dermatitis

Abstract

Background: Antibody responses to the inactivated seasonal influenza vaccine in patients with atopic dermatitis (AD) have not been carefully characterized.

Objective: The primary objective of this study was to compare antibody responses to intradermal vaccination in participants with moderate/severe AD with those in nonatopic participants. Secondary objectives were to evaluate the effect of route of administration, Staphylococcus aureus skin colonization, and disease severity on vaccine response.

Methods: This was an open-label study conducted in the 2012-2013 influenza season at 5 US clinical sites. A total of 360 participants with moderate/severe AD or nonatopic subjects were assessed for eligibility, 347 of whom received intradermal or intramuscular vaccination per label and were followed for 28 days after vaccination. The primary outcome was the difference in the proportion of participants achieving seroprotection (hemagglutination-inhibition antibody titer ≥1:40 on day 28 after vaccination).

Results: Seroprotection rates for influenza B, H1N1, and H3N2 were not different (1) between participants with AD and nonatopic participants receiving intradermal vaccination and (2) between AD participants receiving intradermal and intramuscular vaccination. After intradermal, but not intramuscular, vaccination, participants with AD with S aureus colonization experienced (1) lower seroprotection and seroconversion rates and lower hemagglutination-inhibition antibody titer geometric mean fold increase against influenza B and (2) lower seroconversion rates against influenza H1N1 than noncolonized participants with AD.

Conclusion: Participants with AD colonized with S aureus exhibited a reduced immune response to influenza vaccination compared with noncolonized participants after intradermal but not intramuscular vaccination. Because most patients with AD are colonized with S aureus, intramuscular influenza vaccination should be given preference in these patients.

Keywords: Atopic dermatitis; Staphylococcus aureus; antibody; eczema; influenza; skin; vaccination.

Copyright © 2017 American Academy of Allergy, Asthma & Immunology. All rights reserved.

Figures

Figure 1. Consort Diagram of Study Participants

Note: NA=Non-Atopic; AD=Atopic Dermatitis; ID=Intradermal; IM=Intramuscular; Mod/Sev=Moderate/Severe. 1Methotrexate (not allowed during the study) 2The per protocol population includes participants who 1) received a full dose of vaccine, 2) provided serum samples at baseline and day 28, 3) met eligibility criteria, 4) received no prohibited medications, and 5) had no major protocol deviations.

Figure 2. Day 28 Post-vaccination Influenza B, H1N1 and H3N2 Seroprotection and Seroconversion, by Vaccination Route, Diagnostic Group and S. aureus Skin Colonization

Seroprotection (HAI titers ≥ 1:40) and seroconversion (4-fold or greater increase in HAI titers over baseline titers) percentages and upper 95% confidence intervals are displayed. Pairwise comparisons are performed by the Fisher’s exact test. Note: NA=Non-Atopic; AD=Atopic Dermatitis; ID=Intradermal; IM=Intramuscular; SASC= S. aureus Skin Colonization. Seroprotection is a day 28 hemagglutination-inhibition (HAI) antibody titer >=1:40. Seroconversion is a 4-fold or greater increase in HAI antibody titers from baseline to day 28. Participants with a baseline HAI antibody titer >=1:40 are excluded from the analyses. Pairwise comparisons are made using Fisher’s exact test. Error bars represent exact 95% upper confidence limits.