Safety, Tolerability, Pharmacodynamic Effects and Preliminary Evidence for Efficacy of the Anti-Hypertension Vaccine CYT006-AngQb

This is a multi-center, randomized, placebo-controlled, time-lagged, parallel-group study in healthy and hypertensive subjects to evaluate safety and tolerability of the vaccine CYT006-AngQb. The trial is double-blind for active vs. placebo within each treatment arm, but open with respect to AngQb dose escalation.

In the first arm, 16 healthy normotensive volunteers are treated with a one dose regimen consisting of a single s.c. injection of 100µg of AngQb or placebo. Upon satisfying safety and tolerability profile, as judged by the independent safety monitoring board, arm two is enrolled.

In arm two 36 patients with mild to moderate hypertension receive three s.c. injections of 100µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections are given 4 and 12 weeks after the first injection, respectively. Upon satisfying safety and tolerability profile, as judged by the independent safety monitoring board, arm three is enrolled.

In arm three 36 patients with mild to moderate hypertension receive three s.c. injections of 300µg CYT006-AngQb (24 patients) or placebo (12 patients). The second and third injections are given 4 and 12 weeks after the first injection, respectively.

The primary objective of the trial is to evaluate safety / tolerability of 3 dose regimens of CYT006-AngQb in healthy volunteers and patients with mild to moderate essential hypertension. Secondary objectives include the assessment of pharmacodynamic effects and their dose-response (immunogenicity and biomarkers of the renin-angiotensin system), and the exploration of clinical efficacy (effects on systolic and diastolic blood pressure)

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Key information

Conditions

Essential Hypertension Cardiovascular Diseases Hypertension Vascular Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Patients with untreated mild-to-moderate essential hypertension, clinically diagnosed according to the World Health Organization criteria (systolic blood pressure =140-179 mm Hg and/or diastolic blood pressure =90-109 mm Hg on 3 consecutive occasions; standardized after 5 minutes in sitting position)
Patients with newly diagnosed essential hypertension or previously treated patients from whom antihypertensive therapy can be safely withdrawn for the duration of the study.
18 to 65 years of age, males and non-reproductive females (surgically sterilized or post-menopausal)
Written informed consent
Patient is willing and able to comply with all trial requirements

Exclusion criteria

Secondary hypertension
Severe essential hypertension
Current pharmacological treatment that could affect blood pressure
Significant renal insufficiency [Serum creatinine > 159 µmol/L (> 1.8 mg/dl)]
History of cerebrovascular disease
Type 1 Diabetes or poorly controlled Type 2 Diabetes
Body mass index (BMI) >32
Total cholesterol > 6.9 mmol/L (> 266 mg/dl)
Triglycerides > 3.5 mmol/L ( > 174.3 mg/dl)
Autoimmune diseases or severe allergies
Patients with a history of HIV infection, AIDS, hepatitis B or C, or other immunosuppressive disorders
Current diagnosis or a history of malignancy
Drug or alcohol abuse within the past 2 years
Pregnancy or breastfeeding
Present history of mental diseases
Participation in any drug trial within three month of onset of current trial
Previous participation in a clinical trial with a Qb based vaccine (DerQb, NicQb, AllQb)

Treatment and study plan

CYT006-AngQb

Biological

Sponsors and collaborators

Lead sponsor

Cytos Biotechnology AG

Industry

Registry information

Important dates

Study start: 2004
Primary completion: 2006
Study completion: 2007
First posted: Jul 13, 2007
Registry last updated: Aug 21, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

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