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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.

This study has been completed.
Sponsor:
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00423566
First received: January 17, 2007
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

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 intrdermally by a needle injection in healthy volunteers.


Condition Intervention Phase
Tuberculosis
 Biological: MVA85A (Tuberculosis vaccine)
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: 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.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Oxford:

Primary Outcome Measures:
  • Local and systemic reactions will be monitored 30 and 60 minutes after administration.
  • A photograph of the injection will be taken at 48 hours and this injection site will be reviewed 7 days after each immunisation.
  • Blood will be taken: 1 week after the first vaccination, 1 week after the second vaccination and then at 4, 8, 12 and 24 weeks. The blood is used for a full blood count and biochemical screen.
  • Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay).

Secondary Outcome Measures:
  • Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay).

Estimated Enrollment: 14
Study Start Date: September 2002
Estimated Study Completion Date: July 2003
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423566

Locations
United Kingdom
University of Oxford, Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, United Kingdom, OX3 7LJ
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Helen McShane, MD and PhD University of Oxford
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00423566     History of Changes
Other Study ID Numbers: TB002
Study First Received: January 17, 2007
Last Updated: January 17, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
Mycobacterium tuberculosis
85A antigen
Recombinant Modified Vaccinia virus Ankara
Phase I study
Immunogenicity

Additional relevant MeSH terms:
Tuberculosis
Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections

ClinicalTrials.gov processed this record on May 19, 2013