Vaccine
Conditions
Keywords
Vaccine, hypertension
Brief summary
The study is being conducted to explore the safety and tolerability of CoVaccine HT in healthy male and female volunteers. In this study volunteers will receive intramuscular injections of CoVaccine HT.
Interventions
BIOLOGICALCoVaccine HT
intramuscular injection, dose escalation
Sponsors
BTG International Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
25 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* Adult males or females of non child-bearing potential aged 25 to 65 years inclusive and between 19 and 35 kg/m2 body mass index (BMI) * Generally healthy as determined by pre study medical history, physical examination, 12 lead ECG. * Negative for hepatitis B surface antigen (HBsAg), hepatitis C antibody and human immunodeficiency virus (HIV) I and II tests at screening and rapid influenza diagnostic test at admission.
Exclusion criteria
* History of alcohol abuse in the last 5 years or drug abuse at any time, current significant alcohol consumption. * Fever, active infections (such as influenza) and acute gastrointestinal symptoms following prior to first dosing * Subjects with a previous serious reaction to a vaccine, such as angioedema or anaphylaxis
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Safety Events | Duration of study | Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event. |
Countries
United Kingdom
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 1 mg Dose 1 mg CoVaccine HT | 10 |
| 2 mg Dose 2 mg CoVaccine HT | 10 |
| 5 mg Dose 5 mg CoVaccine HT | 10 |
| 7 mg Dose 7 mg CoVaccine HT | 10 |
| 10 mg Dose 10 mg CoVaccine HT | 10 |
| Total | 50 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 | FG004 |
|---|---|---|---|---|---|---|
| Overall Study | Adverse Event | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Protocol Violation | 1 | 0 | 0 | 0 | 0 |
| Overall Study | Withdrawal by Subject | 0 | 1 | 0 | 0 | 0 |
Baseline characteristics
| Characteristic | 1 mg Dose | Total | 10 mg Dose | 7 mg Dose | 5 mg Dose | 2 mg Dose |
|---|---|---|---|---|---|---|
| Age, Continuous | 41 years STANDARD_DEVIATION 11 | 42 years STANDARD_DEVIATION 10 | 36 years STANDARD_DEVIATION 9 | 44 years STANDARD_DEVIATION 15 | 49 years STANDARD_DEVIATION 9 | 46 years STANDARD_DEVIATION 11 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 1 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 4 Participants | 2 Participants | 0 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 8 Participants | 45 Participants | 8 Participants | 10 Participants | 10 Participants | 9 Participants |
| Sex: Female, Male Female | 1 Participants | 8 Participants | 1 Participants | 3 Participants | 1 Participants | 2 Participants |
| Sex: Female, Male Male | 9 Participants | 42 Participants | 9 Participants | 7 Participants | 9 Participants | 8 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk |
|---|---|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 2 / 10 | 0 / 10 | 4 / 10 | 5 / 10 | 4 / 10 |
| serious Total, serious adverse events | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 | 0 / 10 |
Outcome results
Primary
Safety Events
Safety/tolerability study design of 5 doses of test article administered to healthy volunteers. Each dose was injected 21 days apart. Participants were withdrawn upon experiencing any adverse event.
Time frame: Duration of study
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 1 mg Dose | Safety Events | 20 percentage of patients |
| 2 mg Dose | Safety Events | 0 percentage of patients |
| 5 mg Dose | Safety Events | 40 percentage of patients |
| 7 mg Dose | Safety Events | 50 percentage of patients |
| 10 mg Dose | Safety Events | 40 percentage of patients |