Safety and Efficacy Study of Angiotensin Therapeutic Vaccine in Subjects With Mild to Moderate Hypertension
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
|Hypertension Cardiovascular Disease||Biological: Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant Biological: CoVaccine HT™ adjuvant||Phase 2|
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomised, Double Blind, Placebo Controlled Study of the Efficacy and Safety of Angiotensin Therapeutic Vaccine (ATV) in Subjects With Mild to Moderate Hypertension|
- Change From Baseline to Week 8 in Mean Daytime Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) [ Time Frame: baseline to 8 weeks ]
|Study Start Date:||June 2008|
|Study Completion Date:||September 2010|
|Primary Completion Date:||June 2009 (Final data collection date for primary outcome measure)|
Experimental: ATV with CoVaccine HT™
Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine)
Biological: Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant
Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant given as 3 separate intramuscular injections into the arm, 21 days apart
Placebo Comparator: CoVaccine HT™ adjuvant alone
CoVaccine HT™ adjuvant alone
Biological: CoVaccine HT™ adjuvant
Given as three separate intramuscular injections into the arm, 21 days apart
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00702221
|Fowey River Practice|
|Fowey, Cornwall, United Kingdom, PL23 1DT|
|Penzance, Cornwall, United Kingdom, TR18 4JH|
|Saltash Health Centre|
|Saltash, Cornwall, United Kingdom, PL12 6DL|
|Cape Cornwall Surgery|
|St. Just, Cornwall, United Kingdom, TR19 7HX|
|St. Stephen, Cornwall, United Kingdom, PL26 7RL|
|Chesterfield, Derbyshire, United Kingdom, S40 4FT|
|Knowle House Surgery|
|Plymouth, Devon, United Kingdom, PL5 3JB|
|Layton Medical Centre|
|Blackpool, Lancashire, United Kingdom, FY3 7EN|
|Sherbourne Medical Centre|
|Leamington Spa, Warwickshire, United Kingdom, CV32 4RA|
|Abbey Meads Medical Practice|
|Swindon, Wiltshire, United Kingdom, SN25 4YZ|
|Grey Gable Surgery|
|Inkberrow, Worcestershire, United Kingdom, WR7 4BW|
|The Acumen Pharmaceutical Services Ltd|
|Manchester, United Kingdom, M50 2GY|
|Principal Investigator:||Wajdi H Turkie, MD||The Acumen Pharmaceuticals Services Ltd|