The primary objective is to assess the safety of three dose levels (0.01, 0.1 and 1.0 µg) of the rdESAT-6 + rCFP-10 skin test reagent when injected into healthy adults. The secondary objective is to assess the risk of sensitisation of 0.01 and 0.1 µg rdESAT-6 + rCFP-10 when injected twice with time intervals of 6 or 12 weeks to healthy adults.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Enrollment
42
rdESAT-6 + rCFP-10 skin test administered intradermally by the mantoux injection technique
Rigshospitalet, Epidemiklinikken
Copenhagen, Denmark
Local and systemic adverse events with onset after the FIRST (0.01, 0.1 and 1.0 µg) or SECOND (0.01 and 0.1 µg) injection
Time frame: onset between the first injection and 28 days after the second injection
The diameter of induration at the second injection site measured transversely to the long axis of the forearm
Time frame: 72 hours after the second injection
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