Safety and Efficacy Study of Angiotensin Therapeutic Vaccine in Subjects With Mild to Moderate Hypertension

Phase 2

Terminated

• Conditions: Hypertension; Cardiovascular Disease
• Interventions: Biological: CoVaccine HT™ adjuvant; Biological: Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant

• Registration Number: NCT00702221
• Lead Sponsor: BTG International Inc.

Brief Summary

Angiotensin Therapeutic Vaccine (ATV), which contains the novel adjuvant, CoVaccine HT™ , is being developed for the treatment of high blood pressure (hypertension), a major risk factor for serious diseases such as heart attacks and strokes. Many patients with high blood pressure fail to take their medicines as prescribed because they generally feel well, which often results in poor control of the condition. As a result, it is estimated that about 70% patients with hypertension do not have their blood pressure adequately controlled despite advances in the treatment of high blood pressure.

The main aim of this study is to find out if an injection of ATV given in the arm once every 3 weeks on 3 occasions results in lowering overall blood pressure measurements throughout the day. The other aims are to find out if ATV is safe and to see how well it is tolerated

Detailed Description

One of the causes of hypertension is overactivity of the renin angiotensin system, the main mechanism by which the human body regulates its sodium and water balance. An enzyme called renin cleaves a peptide from the protein angiotensinogen, releasing angiotensin I (AI), which is then converted to a peptide hormone called angiotensin II (AII) by the angiotensin converting enzyme (ACE). Angiotensin II is a hormone which is a powerful vasoconstrictor and increases blood flow to vital organs. Angiotensin Therapeutic Vaccine acts by inducing antibodies which bind to angiotensin, so suppressing its actions.

ATV may offer a way of improving control of blood pressure by increasing patient compliance with treatment. Infrequent vaccinations may provide a sustained reduction in blood pressure and afford a desirable, slow onset of action. Such a vaccine could provide an adjunct to and possibly a replacement for existing therapy in some patients, particularly where patient compliance is likely to be a problem.

This study will determine if three injections of ATV given over the period of six weeks will reduce daytime BP as measured by ambulatory blood pressure monitoring.

The study is split into 2 stages Stage A and Stage B.

The rationale behind Stage A is to closely evaluate the safety and tolerability of ATV in a small number of subjects prior to enroling the majority of subjects into the remaining portion of the study. Stage A will include a minimum of 12 subjects who will receive each of their three injections at a dedicated Phase 1 facility with access to critical care facilities.

Based on the safety profile of the stage A subjects, a recommendation will be made by an independent Data Safety Monitoring Committee on whether to proceed to Stage B.

Stage B will include approximately 112 subjects. As safety and tolerability will have been closely assessed in Stage A, Stage B subjects will be monitored less closely and will be recruited from a number of sites in the UK.

Study Timeline

• Study Start: 2008-06
• Study First Submitted: 2008-06-19
• Study First Submitted QC: 2008-06-19
• Study First Posted: 2008-06-20
• Primary Completion: 2009-06
• Study Completion: 2010-09
• Results First Submitted: 2014-09-10
• Status Verified: 2016-04
• Results First Submitted QC: 2016-06-20
• Last Update Submitted: 2016-06-20
• Results First Posted: 2016-07-29
• Last Update Posted: 2016-07-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CoVaccine HT™ adjuvant alone	CoVaccine HT™ adjuvant	CoVaccine HT™ adjuvant alone
ATV with CoVaccine HT™	Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant	Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)

Primary Outcome Measures

Name	Time	Method
Change From Baseline to Week 8 in Mean Daytime Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM)	baseline to 8 weeks

Trial Locations

Locations (12)

Saltash Health Centre; 🇬🇧 Saltash, Cornwall, United Kingdom

Cape Cornwall Surgery; 🇬🇧 St. Just, Cornwall, United Kingdom

Abbey Meads Medical Practice; 🇬🇧 Swindon, Wiltshire, United Kingdom

Layton Medical Centre; 🇬🇧 Blackpool, Lancashire, United Kingdom

Grey Gable Surgery; 🇬🇧 Inkberrow, Worcestershire, United Kingdom

Brannel Surgery; 🇬🇧 St. Stephen, Cornwall, United Kingdom

Fowey River Practice; 🇬🇧 Fowey, Cornwall, United Kingdom

Knowle House Surgery; 🇬🇧 Plymouth, Devon, United Kingdom

Alverton Practice; 🇬🇧 Penzance, Cornwall, United Kingdom

Avondale Surgery; 🇬🇧 Chesterfield, Derbyshire, United Kingdom

Sherbourne Medical Centre; 🇬🇧 Leamington Spa, Warwickshire, United Kingdom

The Acumen Pharmaceutical Services Ltd; 🇬🇧 Manchester, United Kingdom