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.

Launched by UNIVERSITY OF OXFORD · Jan 17, 2007

Keywords

ClinConnect Summary

1. This is a phase I study to assesss the safety and immunogenicity a recombinant MVA encoding a secreted antigen from Mycobacterium. tuberculosis Antigen 85A, delivered intrdermally by a needle injection in healthy BCG naive volunteers.
2. 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 reading the information leaflet and agreeing to participate. Female volunteers will be...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Healthy adult aged 18-45 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.
• • Positive Heaf test
• • Confirmed pregnancy
• • Previous MVA immunisations