Skip to main content
OpenTrials
Completed

NCT Number: NCT01015703

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

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Vaccine Cardiovascular Diseases Hypertension Vascular Diseases

Age range

25 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Quintiles Drug Research Unit

London, SE1 1YR, United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CoVaccine HT

Biological

intramuscular injection, dose escalation

Primary outcomes

  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 Participants were withdrawn upon experiencing any adverse event.

Sponsors and collaborators

Lead sponsor

BTG International Inc.

Other

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 18, 2009
Registry last updated
Sep 15, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.