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

Exclusion Criteria

• •1. Women of childbearing potential: defined to be not surgically sterile and \<2 y post-menopausal
• •2. Average sitting SBP of \>180 mmHg or DBP of \>110 mmHg.
• •3. A BP difference between left and right arm greater than 20 mmHg for SBP and 10 mmHg for DBP which is present on 3 consecutive readings.
• •4. Left ventricular (LV) systolic dysfunction as evidenced by a known LV ejection fraction \<40% or symptomatic congestive heart failure requiring treatment.
• •5. HbA1c \>7.0% or a history of Type 1 or Type 2 diabetes.
• •6. Haemoglobin \<12 g/dL at Screening.
• •7. Hypo- or hyperthyroidism
• •8. Serum alanine aminotransferase or aspartate aminotransferase \>2X ULN.
• •9. Other identifiable secondary causes of hypertension
• •10. Myocardial infarction, unstable angina pectoris, or a cerebrovascular accident within 6 months of Screening.
• •11. Bradycardia \<50 beats per minute at rest in the supine position prior to randomisation.
• •12. Have sick sinus syndrome or second or third degree atrioventricular block, chronic atrial fibrillation or recurrent atrial tachyarrhythmia (including paroxysmal atrial tachycardia), history of recurrent ventricular tachycardia, or symptomatic bradycardia.
• •13. Implanted pacemakers or cardioverter defibrillator.
• •14. Haemodynamically significant valvular heart disease.
• •15. History of renal dysfunction and/or estimated glomerular filtration rate \<60 mL/min/1.73 m2.
• •16. Diagnosis or recurrence of malignancy within the past 3 years, with the exception of basal cell carcinoma of the skin or in situ carcinoma of the cervix.
• •17. Sleep apnea unless a recent (within 30 days of Screening) sleep study demonstrates no recordings of arterial oxygen saturation (SaO2) \<90%, treated or untreated, at any time during the Screening Period.
• •18. Perform alternating shift or night work.
• •19. Not on stable doses of all concomitant medications for a minimum of 4 weeks prior to Screening, and subjects treated with any of the following prohibited medications:
• •* Oral corticosteroids within 3 months of Screening.
• •* Acetylsalicylic acid in excess of 325 mg per day.
• •* Chronic stable or unstable use of non-steroidal anti-inflammatory drugs (NSAIDs) other than acetylsalicylic acid is prohibited.
• •* Selective serotonin reuptake inhibitors or selective serotonin norepinephrine reuptake inhibitors, if a subject is not compliant with the medication and/or has not been receiving a stable dose for at least 3 months prior to Screening.
• •* Tricyclic antidepressants, if a subject is not compliant with the medication and/or has not been receiving a stable dose for at least 3 months prior to Screening.
• •* Any angiotensin vaccine, including prior exposure to ATV.
• •20. Have participated in a clinical study involving another investigational drug or device within 4 weeks of Screening.
• •21. Any concomitant condition that, in the opinion of the investigator, may adversely affect the safety and/or efficacy of the study drug or severely limit the subject's ability to complete the study (eg, disabling or terminal illness, mental disorders).
• •22. Any major contraindication to stopping antihypertension medications for a period of up to 14 weeks.
• •23. Previous exposure to CoVaccine HT adjuvant, or other keyhole limpet haemocyanin-containing vaccines.
• •24. Previous serious reaction to a vaccine, such as angioedema or anaphylaxis.
• •25. Known history of drug and/or alcohol abuse and those known to be hepatitis positive.