A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers Who Have Received BCG Immunisation 1 Month Previously

Launched by UNIVERSITY OF OXFORD · Jan 26, 2007

Keywords

ClinConnect Summary

This is a phase I study to test the immunogenicity of a recombinant vaccine based on Modified Vaccinia Ankara (MVA) expressing the antigen 85A (from Mycobacterium tuberculosis). This vaccine is delivered intradermally by a needle injection in healthy volunteers who have recieved a BCG immunisation month previously.

1. Selection of volunteers

Volunteers for the study will be recruited through advertisements. Each volunteer will have received an information sheet concerning the study and will have agreed to participate in writing. Volunteers will be given at least 48 hours between readin...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy adult aged 18-55 years.
• • Normal medical history and physical examination.
• • Normal urine dipstick, blood count, liver enzymes, and creatinine.
• Exclusion Criteria:
• • Exposure to TB/BCG vaccination at any point. Previous residence in a TB endemic area.
• • Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
• • Oral or systemic steroid medication or the use of immunosuppressive agents.
• • Positive HIV antibody test, HCV antibody test or positive HBV serology except post-vaccination.
• • Heaf test greater than Grade 0
• • Confirmed pregnancy
• • Previous MVA immunisations