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

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.

Study Overview

• Status: Completed
• Conditions: Vaccine
• Intervention / Treatment: Biological: CoVaccine HT

• Study Type: Interventional
• Enrollment (Actual): 50
• Phase: Phase 1

Contacts and Locations

Study Locations

• United Kingdom
  • London, United Kingdom, SE1 1YR
    • Quintiles Drug Research Unit

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 25 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: CoVaccine HT	Biological: CoVaccine HT; intramuscular injection, dose escalation

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Participants were withdrawn upon experiencing any adverse event.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

Collaborators and Investigators

• Sponsor: BTG International Inc.
• Investigators: Principal Investigator: Darren Wilbraham, MB., BS, Quintiles, Inc.

Study record dates

Study Major Dates

• Study Start: November 1, 2009
• Primary Completion (Actual): June 1, 2010
• Study Completion (Actual): June 1, 2010

Study Registration Dates

• First Submitted: November 17, 2009
• First Submitted That Met QC Criteria: November 17, 2009
• First Posted (Estimate): November 18, 2009

Study Record Updates

• Last Update Posted (Estimate): September 15, 2014
• Last Update Submitted That Met QC Criteria: September 9, 2014
• Last Verified: September 1, 2014

More Information

Terms related to this study

• Keywords: Vaccine, hypertension
• Other Study ID Numbers: PR002-CLN-pro010