The purpose of this study is to show that ViscoGel® is safe when administrated alone and as an adjuvant together with Act-HIB® vaccine in healthy volunteers and to evaluate the quantitative and qualitative effect on the immune response.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
130
0.2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
Pre-selected dose of ViscoGel® (from phase A) and Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
Pre-selected dose of ViscoGel® (from phase A) and 2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
Karolinska Trial Alliance
Stockholm, Sweden
Incidence and type of adverse events, severe adverse events and SUSAR
Phase A: 3 consecutive groups each of 10 subjects. Planned dose of ViscoGel® (provided that the data safety monitoring board deemed the previous dose level to be safe): 25mg, 50mg and 75mg.
Time frame: Up to 28 days post injection
Change in HIB antibody serum titer
Phase B: The ViscoGel® dose administrated will be chosen after evaluation of safety and tolerance in Phase A. 2 subjects from group 1 and 2 subjects from group 3 will initially receive ViscoGel® dose (from phase A) with Act-HIB non-randomized. The remaining subjects will be randomized to 5 different treatment arms. Group 1; ViscoGel® with 0.2µg Act-HIB, Group 2; 0.2µg Act-HIB, Group 3; ViscoGel® with 2µg Act-HIB, Group 4; 2µg Act-HIB and Group 5 10µg Act-HIB is given. Blood samples are obtained at baseline and post-injection for assessment of HIB antibody serum titer.
Time frame: 28 days post vaccination
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2μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.
Clinical standard dose of 10μg Act-HIB® vaccine, IM (intramuscular) on day 0 of phase B.