Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension

Phase 2

Completed

• Conditions: Mild Essential Hypertension; Moderate Essential Hypertension
• Interventions: Biological: CYT006-AngQb

• Registration Number: NCT00710372
• Lead Sponsor: Cytos Biotechnology AG

Brief Summary

The study medication CYT006-AngQb is a vaccine, consisting of angiotensin II (Ang II), the naturally occurring octapeptide coupled onto the surface of virus-like particles (VLP). This form of presenting Ang II to the immune system induces a B-cell mediated immune response characterized by the generation of specific antibodies (IgG and IgM) against Ang II. The CYT006-AngQb vaccine is administered by subcutaneous (s.c.) injection. Immunization against angiotensin II may offer a valuable alternative to conventional drugs for the treatment of hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-07-03
• Study First Submitted QC: 2008-07-03
• Study First Posted: 2008-07-04
• Primary Completion: 2009-07
• Status Verified: 2010-11
• Study Completion: 2010-11
• Last Update Submitted: 2010-11-11
• Last Update Posted: 2010-11-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 83

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 baseline ABPM measurement (SBP >135 mmHg).
• Stable baseline blood pressure confirmed on 2 consecutive visits (screening and V1). (Changes <20mmHg for sitting office SBP and <10mmHg for mean sitting office DPB).
• Patients without current antihypertensive therapy. Patients on previous mono-antihypertensive therapy, who can safely stop their medication
• Patient is willing and able to comply with all trial requirements and procedures.

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 meansitting 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/ clinically relevant heart failure (NYHA class II-IV)/ Peripheral artery disease/ Diabetic nephropathy

• Electrocardiographic confirmed left ventricular hypertrophy

• Increased plasma creatinine

• Diabetes mellitus type I, history, presence or new diagnosis of diabetes mellitus type II.

• Postural hypotension at screening

• Arrhythmias that would interfere with the oscilloscopic measurement of the blood pressure.

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	CYT006-AngQb	CYT006-AngQb
2	CYT006-AngQb	-

Primary Outcome Measures

Name	Time	Method
Adverse events: quality, quantity, severity	throughout complete study until week 48

Secondary Outcome Measures

Name	Time	Method
Change in daytime, nighttime and 24h ambulatory blood pressure from baseline	24 hours
anti-Angio II IgG antibody titer	throughout complete study until week 48
Level of RAS Biomarkers (concentrations of plasma renin, angiotensinII and aldosterone)	24 h

Trial Locations

Locations (1)

Cytos Biotechnology (Sponsor's Headquarter); 🇨🇭 Schlieren, Switzerland