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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01015703
Recruitment Status : Completed
First Posted : November 18, 2009
Results First Posted : September 15, 2014
Last Update Posted : September 15, 2014
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Vaccine Biological: CoVaccine HT Phase 1

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : November 2009
Actual Primary Completion Date : June 2010
Actual Study Completion Date : June 2010

Arm Intervention/treatment
Experimental: CoVaccine HT Biological: CoVaccine HT
intramuscular injection, dose escalation

Primary Outcome Measures :
  1. Safety Events [ Time Frame: 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 Participants were withdrawn upon experiencing any adverse event.

Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01015703

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

Responsible Party: BTG International Inc. Identifier: NCT01015703     History of Changes
Other Study ID Numbers: PR002-CLN-pro010
First Posted: November 18, 2009    Key Record Dates
Results First Posted: September 15, 2014
Last Update Posted: September 15, 2014
Last Verified: September 2014

Keywords provided by BTG International Inc.:
Vaccine, hypertension