Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Exploratory Efficacy of a Vaccine Against Essential Hypertension

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00701649
Recruitment Status : Completed
First Posted : June 19, 2008
Last Update Posted : December 2, 2009
Information provided by:
Cytos Biotechnology AG

Brief Summary:

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.

Condition or disease Intervention/treatment Phase
Hypertension Biological: CYT006-AngQb Biological: Placebo Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Double Blind, Randomized, Placebo Controlled, Parallel Group Phase IIa Study to Evaluate Safety and Tolerability, Pharmacodynamic Effects and Exploratory Efficacy of an Anti-Angiotensin II Vaccine (CYT006-AngQb) in Patients With Mild to Moderate Essential Hypertension
Study Start Date : March 2008
Actual Primary Completion Date : March 2009
Actual Study Completion Date : November 2009

Arm Intervention/treatment
Experimental: 1 Biological: CYT006-AngQb
Placebo Comparator: 2 Biological: Placebo

Primary Outcome Measures :
  1. Adverse events: quality, quantity, severity [ Time Frame: Throughout the study until week 48 ]

Secondary Outcome Measures :
  1. Change in daytime, nighttime and 24-hour ambulatory blood pressure from baseline [ Time Frame: 24 hours ]
  2. Titer of IgG specific for angiotensin II [ Time Frame: Throughout the study untill week 48 ]
  3. Amount of RAS-Biomarkers (plasma renin concentration, angiotensin II, aldosterone) [ Time Frame: 24 hours ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 69 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Patients with mild to moderate essential hypertension (Grade I and Grade II) with mean sitting office SBP =140-179 mmHg and/or mean sitting office DBP = 90-109 mmHg on 2 consecutive visits (screening and V1).
  • Daytime blood pressure above threshold for definition of hypertension in the screening ABPM measurement (SBP >135 mmHg).
  • Patients without current antihypertensive therapy.
  • Patients on antihypertensive therapy, which can be stopped.
  • 18 to 69 years of age.
  • Male patients, or female patients without childbearing potential .

Exclusion Criteria:

  • Patients with "very high added risk" according to 2007 Guidelines for the Management of Arterial Hypertension (Journal of Hypertension, 2007, 25:1105-1187), i.e. those with:
  • grade III hypertension (mean sitting office SBP ≥180mmHg and/or mean sitting DBP≥110mmHg)
  • history or presence of established cardiovascular or renal disease:
  • Ischemic stroke, cerebral hemorrhage, transient ischemic attack
  • Myocardial infarction, angina pectoris, coronary re-vascularization, heart failure
  • Peripheral artery disease
  • Diabetic nephropathy
  • Known autoimmune disease.
  • Severe allergy.
  • Pregnancy or breastfeeding.
  • Women in childbearing age that are not surgically sterilized.
  • Patients with a history or current positive test for HIV infection, AIDS, or other immunosuppressive disorders; hepatitis B or C.
  • Current diagnosis or history of malignancy.
  • Presence of suspicious lymphadenopathy or splenomegaly on physical examination.
  • Drug or alcohol abuse within the past 2 years.
  • Presence or history of relevant cardiovascular, renal, hepatic, pulmonary, endocrine, autoimmune, neurological and psychiatric disease as judged by the investigator.
  • Any current or past disease or conditions (physical or mental) that would, in the opinion of the investigator, interfere with the study procedures or interpretation of the study data (e.g. workers in the night shift).
  • Previous participation in a clinical trial with a Qb based vaccine.
  • Use of an investigational drug within 3 months before enrolment, or planned use during the whole study period.
  • Possible dependency of the patient on sponsor and/or investigator.
  • Planned active immunization 2 weeks before or 2 weeks after any study medication vaccination.
  • Donation or loss >=400 mL of blood within 8 weeks prior to dosing or major surgery within past 2 months.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00701649

CRS Mannheim
Mannheim, Germany, D-68167
CRS Mönchengladbach
Mönchengladbach, Germany, D-41061
University Hospital Basel
Basel, Switzerland, CH-4031
Bern, Switzerland, CH-3010
Hopital Universitaire Geneve
Geneva, Switzerland, CH-1211
Med Zentrum Römerhof
Zürich, Switzerland, CH-8091
Sponsors and Collaborators
Cytos Biotechnology AG

Responsible Party: Prof. Dr. med. Jürg Nussberger, Hôpital Nestlé 6027, CHUV, CH-1011 Lausanne, Switzerland Identifier: NCT00701649     History of Changes
Other Study ID Numbers: CYT006-AngQb 02
Eudract No. 2007-005843-93
First Posted: June 19, 2008    Key Record Dates
Last Update Posted: December 2, 2009
Last Verified: December 2009

Keywords provided by Cytos Biotechnology AG:
mild essential hypertension
moderate essential hypertension

Additional relevant MeSH terms:
Vascular Diseases
Cardiovascular Diseases