Trial Outcomes & Findings for Safety and Efficacy Study of Angiotensin Therapeutic Vaccine in Subjects With Mild to Moderate Hypertension (NCT NCT00702221)

NCT ID: NCT00702221

Last Updated: 2016-07-29

Results Overview

• Recruitment status: TERMINATED
• Study phase: PHASE2
• Target enrollment: 20 participants
• Primary outcome timeframe: baseline to 8 weeks
• Results posted on: 2016-07-29

Participant Flow

Participant milestones

Measure	Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine) Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart	CoVaccine HT™ Adjuvant Alone (Control) CoVaccine HT™ adjuvant alone CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart
Overall Study STARTED	10	10
Overall Study COMPLETED	6	7
Overall Study NOT COMPLETED	4	3

Reasons for withdrawal

Measure	Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine) Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart	CoVaccine HT™ Adjuvant Alone (Control) CoVaccine HT™ adjuvant alone CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart
Overall Study Adverse Event	4	3

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant n=6 Participants Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine) Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart	CoVaccine HT™ Adjuvant Alone (Control) n=7 Participants CoVaccine HT™ adjuvant alone CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart	Total n=13 Participants Total of all reporting groups
Age, Continuous	51.8 years STANDARD_DEVIATION 6.94 • n=5 Participants	53.7 years STANDARD_DEVIATION 6.63 • n=7 Participants	52.8 years STANDARD_DEVIATION 6.56 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants	6 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	1 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) White	6 Participants n=5 Participants	5 Participants n=7 Participants	11 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	1 Participants n=7 Participants	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: baseline to 8 weeks

Population: study prematurely terminated

Outcome measures

Measure	Angiotensin Therapeutic Vaccine + CoVaccine HT™ Adjuvant n=6 Participants Angiotensin Therapeutic Vaccine + CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine) Angiotensin Therapeutic Vaccine + CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart	CoVaccine HT™ Adjuvant Alone (Control) n=7 Participants CoVaccine HT™ adjuvant alone CoVaccine HT™ adjuvant: 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)	-7.18 mmHg Standard Error 3.451	-3.68 mmHg Standard Error 3.049

Adverse Events

Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant

Serious events: 0 serious events

Other events: 10 other events

Deaths: 0 deaths

CoVaccine HT™ Adjuvant Alone (Control)

Serious events: 1 serious events

Other events: 10 other events

Deaths: 0 deaths

Serious adverse events

Measure	Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant n=10 participants at risk Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine) Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart	CoVaccine HT™ Adjuvant Alone (Control) n=10 participants at risk CoVaccine HT™ adjuvant alone CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart
General disorders cellulitis	0.00% 0/10 • 8 weeks	10.0% 1/10 • Number of events 1 • 8 weeks

Other adverse events

Measure	Angiotensin Therapeutic Vaccine With CoVaccine HT™ Adjuvant n=10 participants at risk Angiotensin Therapeutic Vaccine with CoVaccine HT™ adjuvant (an ingredient that may improve the immune response of the vaccine) Angiotensin Therapeutic Vaccine plus CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart	CoVaccine HT™ Adjuvant Alone (Control) n=10 participants at risk CoVaccine HT™ adjuvant alone CoVaccine HT™ adjuvant: Given as three separate intramuscular injections into the arm, 21 days apart
General disorders injection site pain	90.0% 9/10 • Number of events 9 • 8 weeks	80.0% 8/10 • Number of events 8 • 8 weeks
General disorders chills	40.0% 4/10 • Number of events 4 • 8 weeks	30.0% 3/10 • Number of events 3 • 8 weeks
General disorders pain	20.0% 2/10 • Number of events 2 • 8 weeks	0.00% 0/10 • 8 weeks
Nervous system disorders headache	90.0% 9/10 • Number of events 9 • 8 weeks	60.0% 6/10 • Number of events 6 • 8 weeks
Nervous system disorders hyperesthesia	10.0% 1/10 • Number of events 1 • 8 weeks	0.00% 0/10 • 8 weeks
Cardiac disorders tachycardia	30.0% 3/10 • Number of events 3 • 8 weeks	10.0% 1/10 • Number of events 1 • 8 weeks
Metabolism and nutrition disorders anorexia	10.0% 1/10 • Number of events 1 • 8 weeks	0.00% 0/10 • 8 weeks
Gastrointestinal disorders diarrhea	10.0% 1/10 • Number of events 1 • 8 weeks	10.0% 1/10 • Number of events 1 • 8 weeks
Infections and infestations respiratory tract infection	10.0% 1/10 • Number of events 1 • 8 weeks	10.0% 1/10 • Number of events 1 • 8 weeks
General disorders cellulitis	0.00% 0/10 • 8 weeks	10.0% 1/10 • Number of events 1 • 8 weeks

Additional Information

SVP, Clinical Development

BTG International Inc.

Phone: 610-278-1660

Email: thomas.king@btgplc.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place