Open-label Safety and Tolerability Study of CoVaccine HT™ in Healthy Volunteers
Phase 1
Completed
- Conditions
- Vaccine
- Interventions
- Biological: CoVaccine HT
- Registration Number
- NCT01015703
- Lead Sponsor
- BTG International Inc.
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 50
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CoVaccine HT CoVaccine HT -
- Primary Outcome Measures
Name Time Method 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 Participants were withdrawn upon experiencing any adverse event.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Quintiles Drug Research Unit
🇬🇧London, United Kingdom