Phase 1 N=50 Basic Science

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

Vaccine

Bottom Line

View on ClinicalTrials.gov: NCT01015703 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Sep 2014

Primary outcome: Primary: Safety Events — 20; 0; 40; 50 percentage of patients

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: CoVaccine HT (Biological)
Age: Adult, Older Adult · 25+ yrs
Sex: All
Sponsor: BTG International Inc.
Primary completion: Jun 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Safety Events	20; 0; 40; 50; 40	—

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01015703). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.