CYT006-AngQb is a vaccine that induces a B-cell mediated immune response characterized by the generation of specific antibodies (IgG and IgM) against Angiotensin II. The vaccine is administered by subcutaneous injection. The objectives of the study are: * To evaluate safety and tolerability of 5 s.c. injections of 300µg CYT006-AngQb with Alhydrogel™ in patients with mild to moderate essential hypertension (hypertension Grade I and II). * To assess pharmacodynamic effects, i.e. anti-Ang II immune response and renin- angiotensin system (RAS) biomarkers. * To explore the effect on blood pressure using ABPM.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
60
s.c.
s.c.
CRS Mannheim
Mannheim, Germany
CRS Mönchengladbach
Mönchengladbach, Germany
University Hospital Basel
Basel, Switzerland
Inselspital
Bern, Switzerland
Hopital Universitaire Geneve
Geneva, Switzerland
Med Zentrum Römerhof
Zurich, Switzerland
Adverse events: quality, quantity, severity
Time frame: Throughout the study until week 48
Change in daytime, nighttime and 24-hour ambulatory blood pressure from baseline
Time frame: 24 hours
Titer of IgG specific for angiotensin II
Time frame: Throughout the study untill week 48
Amount of RAS-Biomarkers (plasma renin concentration, angiotensin II, aldosterone)
Time frame: 24 hours
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