Immune Response to Yellow Fever Vaccination in Adults With Atopic Dermatitis

Phase 1/2 Completed 82 enrolled National Institute of Allergy and Infectious Diseases (NIAID)

RandomizedParallel-groupQuadruple-blindBasic science

Summary

The main objective of the Atopic Dermatitis and Vaccinia Immunization Network (ADVN) is to reduce the risk of the fatal reaction, eczema vaccinatum (EV), to the smallpox vaccination in those with atopic dermatitis (AD). Since vaccination with live vaccinia virus (VV) in individuals with AD increases the risk of EV, a yellow fever vaccine was chosen. The purpose of this study is to determine the immune response to a yellow fever vaccine in adults with AD.

Timeline

Start: 2008-08
Primary completion: 2011-04
Completion: 2011-04

Outcome

Missed primary endpoint

registry YFV-17D TC - (AD) vs YFV-17D TC - (Non-AD); p = 0.86; Mean Difference (Final Values) -0.02 (95% CI -0.3 to 0.2); ANOVA NCT00723489 ↗

registry YFV-17D SC - (AD) vs YFV-17D SC - (Non-AD); p = 0.86; Mean Difference (Final Values) 0.02 (95% CI -0.2 to 0.2); ANOVA NCT00723489 ↗

registry YFV-17D SC - (AD) vs YFV-17D SC - (Non-AD); p = 0.66; Mean Difference (Final Values) 0.1 (95% CI -0.2 to 0.3); ANOVA NCT00723489 ↗

Publications

Slifka MK, Leung DY, Hammarlund E, Raue HP, Simpson EL, Tofte S, Baig-Lewis S, David G, Lynn H, Woolson R, Hata T, Milgrom H, Hanifin J. Transcutaneous yellow fever vaccination of subjects with or without atopic dermatitis. J Allergy Clin Immunol. 2014 Feb;133(2):439-47. doi: 10.1016/j.jaci.2013.10.037. Epub 2013 Dec 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	YFV-17D	Vaccine	1000 unknown	Subcutaneous
Subject	YFV-17D	Vaccine	55000 unknown	Subcutaneous