A Phase 2 interventional study of Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant and CoVaccine HT™ adjuvant in Hypertension and Cardiovascular Disease, sponsored by BTG International Inc.. Terminated at 12 sites in United Kingdom. Open to participants aged 35 Years to 70 Years. Per ClinicalTrials.gov, last updated 2016-07-29.
Sponsored by BTG International Inc. · Phase 2, Interventional, and Treatment
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
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.
6,114 studies on the registry are indexed under Hypertension; 912 are open to participants now.
This study's enrollment of 20 is below the median of 100 across 4,575 interventional studies indexed under Hypertension.
Browse Hypertension studies →BTG International Inc. is the lead sponsor of 12 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria (at randomisation):
Principal exclusion criteria:
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:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
LVEF (left ventricular ejection fraction)
The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HbA1c
A blood test of average blood sugar over the past two to three months, given as a percentage or in mmol/mol. 6.5% (48 mmol/mol) or more is the usual threshold for diabetes, normally confirmed by a second test.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
GFR and eGFR (kidney filtering)
GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².
Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
CoVaccine HT™ adjuvant alone
Biological: CoVaccine HT™ adjuvant
Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant given as 3 separate intramuscular injections into the arm, 21 days apart
Given as three separate intramuscular injections into the arm, 21 days apart
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
| Milestone | Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant | CoVaccine HT™ Adjuvant Alone (Control) |
|---|---|---|
| Started | 10 | 10 |
| Completed | 6 | 7 |
| Not completed | 4 | 3 |
| Withdrew: Adverse event | 4 | 3 |
| mmHg | Angiotensin Therapeutic Vaccine + CoVaccine HT™ Adjuvant | CoVaccine HT™ Adjuvant Alone (Control) |
|---|---|---|
| Change From Baseline to Week 8 in Mean Daytime Diastolic Blood Pressure (DBP) Measured by Ambulatory Blood Pressure Monitoring (ABPM) | -7.18 ± 3.451 | -3.68 ± 3.049 |
Collected over 8 weeks. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant | — | 0/10 (0%) | 10/10 (100%) |
| CoVaccine HT™ Adjuvant Alone (Control) | — | 1/10 (10%) | 10/10 (100%) |
| Event | Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant | CoVaccine HT™ Adjuvant Alone (Control) |
|---|---|---|
| cellulitisGeneral disorders | 0/10 | 1/10 |
| Event | Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant | CoVaccine HT™ Adjuvant Alone (Control) |
|---|---|---|
| injection site painGeneral disorders | 9/10 | 8/10 |
| headacheNervous system disorders | 9/10 | 6/10 |
| chillsGeneral disorders | 4/10 | 3/10 |
| tachycardiaCardiac disorders | 3/10 | 1/10 |
| painGeneral disorders | 2/10 | 0/10 |
| hyperesthesiaNervous system disorders | 1/10 | 0/10 |
| anorexiaMetabolism and nutrition disorders | 1/10 | 0/10 |
| diarrheaGastrointestinal disorders | 1/10 | 1/10 |
| respiratory tract infectionInfections and infestations | 1/10 | 1/10 |
| cellulitisGeneral disorders | 0/10 | 1/10 |
All analyzed subjects
| Age, Continuous(years) | Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant | CoVaccine HT™ Adjuvant Alone (Control) | Total |
|---|---|---|---|
| Mean | 51.8 ± 6.94 | 53.7 ± 6.63 | 52.8 ± 6.56 |
| Sex: Female, Male(Participants) | Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant | CoVaccine HT™ Adjuvant Alone (Control) | Total |
|---|---|---|---|
| Female | 1 | 6 | 7 |
| Male | 5 | 1 | 6 |
| Race (NIH/OMB)(Participants) | Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant | CoVaccine HT™ Adjuvant Alone (Control) | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 6 | 5 | 11 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 1 | 1 |
Plan to share: Yes — Investigators provide information to participants
No publications or documents are linked to this record.
The record gives a start of Jun 2008, a primary completion of Jun 2009 and a completion of Sep 2010. It does not say whether these dates are actual or estimated.
Results were first posted in Jul 2016, 7 years 1 month after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Apr 2016. You cannot join it, but the record below documents what was studied.
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BTG International Inc.