The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Enrollment
20
o,5 mL suspension for injection x 2 with 2 months interval
o,5 mL suspension for injection x 2 with 2 months interval
Leiden University Medical Centre
Leiden, RC Leiden, Netherlands
Physical examination. Local adverse events.Systemic adverse events. Laboratory safety tests including urine safety tests.
Time frame: From first vaccination until 8 months after the first vaccination
Detection by ELISPOT of IFNgamma spot-forming cells in PBMCs. Detection by ELISA of IFNgamma production in supernatants of PBMC. Detection by ELISA of IgG antibodies in serum/plasma. Detection by Elisa of TNFalfa and IFNgamma in serum
Time frame: From first vaccination until 8 months after first vaccination
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