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

BTG

Status and phase: Completed; Phase 1

Conditions: Vaccine

Treatments: Biological: CoVaccine HT

Study type: Interventional

Funder types: Other

Identifiers

NCT01015703

PR002-CLN-pro010

Details and patient eligibility

About

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.

Enrollment: 50 patients

Sex: All

Ages: 25 to 65 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

CoVaccine HT

Experimental group

Treatment:

Biological: CoVaccine HT