This is a Phase I, randomized, placebo-controlled, single blind, parallel group, single-center study designed to evaluate immune responses during and after administration of 12 weekly SC doses of 1.0 mg/kg efalizumab in subjects with moderate plaque psoriasis.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
60
Mean concentrations of anti-<phi>X174 antibodies in the FU period 2 weeks after the FU Day 70 vaccinations in Group A compared with mean antibody concentrations 2 weeks after the Treatment Day 63 vaccination in Group C
Mean concentrations of anti-<phi>X174 antibodies in the FU period 2 weeks after the FU Day 70 vaccination in Group B compared with mean antibody concentrations 2 weeks after the Treatment Day 63 vaccination in Group C.
Characterization of mean concentrations of anti-<phi>X174 antibodies 2 weeks after the FU Day 42 vaccination in Group A compared with mean antibody concentrations 2 weeks after the Treatment Day 35 vaccination in Group C
Characterization of mean concentrations of anti-<phi>X174 antibodies 2 weeks after the FU Day 42 vaccination in Group B compared with mean antibody concentrations 2 weeks after the Treatment Day 35 vaccination in Group C
Characterization of mean anti-<phi>X174 concentrations 2 and 4 weeks after the first and 2 and 4 weeks after the second <phi>X174 vaccinations during efalizumab treatment (Group A) compared with placebo (Group C)
Characterization of mean concentrations of anti-tetanus IgG during treatment with efalizumab compared with placebo, representing a secondary humoral immune response
Characterization of anti-pneumococcal antibody concentrations on FU Day 70 after pneumococcal vaccination on FU Day 42 compared with placebo
Percentage of subjects with positive skin test reactions to tetanus and Candida-recall antigens on FU Day 77 after washout from efalizumab compared with baseline.
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