Safety, Tolerability and Efficacy of a Vaccine Against Essential Hypertension

Cytos Biotechnology

Status and phase

Completed

Phase 2

Conditions

Mild Essential Hypertension

Moderate Essential Hypertension

Treatments

Biological: CYT006-AngQb

Study type

Interventional

Funder types

Industry

Identifiers

NCT00710372

EudraCT No.: 2007-007516-28

CYT006-AngQb 03

Details and patient eligibility

About

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.

Enrollment

83 patients

Sex

All

Ages

18 to 69 years old

Volunteers

No Healthy Volunteers

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.