Open-label Safety and Tolerability Study of CoVaccine HT™ in Healthy Volunteers
A Phase 1, Open-Label, Dose Escalation Study of the Safety and Tolerability of CoVaccine HT™ in Healthy Adult Volunteers
1 other identifier
interventional
50
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Nov 2009
Shorter than P25 for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2009
CompletedFirst Submitted
Initial submission to the registry
November 17, 2009
CompletedFirst Posted
Study publicly available on registry
November 18, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedResults Posted
Study results publicly available
September 15, 2014
CompletedSeptember 15, 2014
September 1, 2014
7 months
November 17, 2009
June 4, 2014
September 9, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Participants were withdrawn upon experiencing any adverse event.
Duration of study
Study Arms (1)
CoVaccine HT
EXPERIMENTALInterventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Quintiles Drug Research Unit
London, SE1 1YR, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- SVP Clinical Development
- Organization
- BTG International Inc.
Study Officials
- PRINCIPAL INVESTIGATOR
Darren Wilbraham, MB., BS
Quintiles, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 17, 2009
First Posted
November 18, 2009
Study Start
November 1, 2009
Primary Completion
June 1, 2010
Study Completion
June 1, 2010
Last Updated
September 15, 2014
Results First Posted
September 15, 2014
Record last verified: 2014-09