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Status:

COMPLETED

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.

Lead Sponsor:

University of Oxford

Conditions:

Tuberculosis

Eligibility:

All Genders

18-45 years

Phase:

PHASE1

Brief Summary

This study is to assesss the safety and immunogenicity of vaccine based on Modified Vaccinia Ankara (MVA) expressing the 85A antigen (from Mycobacterium. tuberculosis). This vaccine is delivered intrd...

Detailed Description

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 injec...

Eligibility Criteria

Inclusion

  • Healthy adult aged 18-45 years.
  • Normal medical history and physical examination.
  • Normal urine dipstick, blood count, liver enzymes, and creatinine.

Exclusion

  • 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

Key Trial Info

Start Date :

September 1 2002

Trial Type :

INTERVENTIONAL

End Date :

July 1 2003

Estimated Enrollment :

14 Patients enrolled

Trial Details

Trial ID

NCT00423566

Start Date

September 1 2002

End Date

July 1 2003

Last Update

January 18 2007

Active Locations (1)

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University of Oxford, Centre for Clinical Vaccinology and Tropical Medicine

Oxford, Oxfordshire, United Kingdom, OX3 7LJ