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

Vaccine Clinical Trial

Official title:

A Phase 1, Open-Label, Dose Escalation Study of the Safety and Tolerability of CoVaccine HT™ in Healthy Adult Volunteers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01015703
• Other study ID #: PR002-CLN-pro010
• Status: Completed
• Phase: Phase 1
• First received: November 17, 2009
• Last updated: September 9, 2014
• Start date: November 2009
• Est. completion date: June 2010

Study information

• Verified date: September 2014
• Source: BTG International Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 25 Years to 65 Years

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Vaccine

Intervention

Biological:
• CoVaccine HT
intramuscular injection, dose escalation

Locations

Country	Name	City	State
United Kingdom	Quintiles Drug Research Unit	London

Sponsors (1)

Lead Sponsor	Collaborator
BTG International Inc.

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes