Open-label Safety and Tolerability Study of CoVaccine HT™ in Healthy Volunteers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
BTG International Inc.
ClinicalTrials.gov Identifier:
NCT01015703
First received: November 17, 2009
Last updated: September 9, 2014
Last verified: September 2014
  Purpose

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.


Condition Intervention Phase
Vaccine
Biological: CoVaccine HT
Phase 1

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1, Open-Label, Dose Escalation Study of the Safety and Tolerability of CoVaccine HT™ in Healthy Adult Volunteers

Further study details as provided by BTG International Inc.:

Primary Outcome Measures:
  • Safety Events [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]
    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 Participants were withdrawn upon experiencing any adverse event.


Enrollment: 50
Study Start Date: November 2009
Study Completion Date: June 2010
Primary Completion Date: June 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CoVaccine HT Biological: CoVaccine HT
intramuscular injection, dose escalation

  Eligibility

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01015703

Locations
United Kingdom
Quintiles Drug Research Unit
London, United Kingdom, SE1 1YR
Sponsors and Collaborators
BTG International Inc.
Investigators
Principal Investigator: Darren Wilbraham, MB., BS Quintiles
  More Information

No publications provided

Responsible Party: BTG International Inc.
ClinicalTrials.gov Identifier: NCT01015703     History of Changes
Other Study ID Numbers: PR002-CLN-pro010
Study First Received: November 17, 2009
Results First Received: June 4, 2014
Last Updated: September 9, 2014
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by BTG International Inc.:
Vaccine, hypertension

ClinicalTrials.gov processed this record on October 23, 2014