TY - JOUR
T1 - Risk of sensitization in healthy adults following repeated administration of rdESAT-6 skin test reagent by the Mantoux injection technique
AU - Lillebaek, Troels
AU - Bergstedt, Winnie
AU - Tingskov, Pernille N
AU - Thierry-Carstensen, Birgit
AU - Aggerbeck, Henrik
AU - Hoff, Soeren T
AU - Weldingh, Karin
AU - Andersen, Peter
AU - Soborg, Bolette
AU - Thomsen, Vibeke O
AU - Andersen, Aase B
N1 - Keywords: Adolescent; Adult; Antigens, Bacterial; Bacterial Proteins; Female; Humans; Hypersensitivity, Delayed; Injections, Intradermal; Interferon-gamma; Intradermal Tests; Male; Middle Aged; Tuberculosis; Young Adult
PY - 2009
Y1 - 2009
N2 - Limited specificity of the tuberculin skin test incited the development of the intradermal Mycobacterium tuberculosis-specific rdESAT-6 skin test. Animal studies have shown, however, that there is a possible risk of sensitization when repeated injections of rdESAT-6 are given. The aim of this phase 1 open clinical trial was to assess the sensitization risk and safety of repeated administration of rdESAT-6 reagent in 31 healthy adult volunteers. Three groups of volunteers received two fixed doses of 0.1 microg rdESAT-6 28, 56 or 112 days apart, respectively. After the second injection, the diameter of induration and/or redness at the injection site was measured and taken as a possible sensitization reaction if >5mm. In vitro interferon gamma (IFN-gamma) responses were measured as supportive evidence. Local adverse reactions at the injection site and adverse events were recorded. One out of 31 (3%) volunteers showed a positive skin reaction (sensitization) upon a second injection of rdESAT-6 after 28days and an increased IFN-gamma response to ESAT-6. For 7 (23%) of the volunteers, local adverse reactions related to the product were registered, but all reactions were mild and predictable. In conclusion, repeated injections of the rdESAT-6 skin test reagent are safe, and sensitization occurs at a low rate, especially if the time span between succeeding doses is wide.
AB - Limited specificity of the tuberculin skin test incited the development of the intradermal Mycobacterium tuberculosis-specific rdESAT-6 skin test. Animal studies have shown, however, that there is a possible risk of sensitization when repeated injections of rdESAT-6 are given. The aim of this phase 1 open clinical trial was to assess the sensitization risk and safety of repeated administration of rdESAT-6 reagent in 31 healthy adult volunteers. Three groups of volunteers received two fixed doses of 0.1 microg rdESAT-6 28, 56 or 112 days apart, respectively. After the second injection, the diameter of induration and/or redness at the injection site was measured and taken as a possible sensitization reaction if >5mm. In vitro interferon gamma (IFN-gamma) responses were measured as supportive evidence. Local adverse reactions at the injection site and adverse events were recorded. One out of 31 (3%) volunteers showed a positive skin reaction (sensitization) upon a second injection of rdESAT-6 after 28days and an increased IFN-gamma response to ESAT-6. For 7 (23%) of the volunteers, local adverse reactions related to the product were registered, but all reactions were mild and predictable. In conclusion, repeated injections of the rdESAT-6 skin test reagent are safe, and sensitization occurs at a low rate, especially if the time span between succeeding doses is wide.
U2 - 10.1016/j.tube.2008.09.007
DO - 10.1016/j.tube.2008.09.007
M3 - Journal article
C2 - 19208500
SN - 1472-9792
VL - 89
SP - 158
EP - 162
JO - Tuberculosis
JF - Tuberculosis
IS - 2
ER -
