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Safety and Immunogenicity of MVA85A in Volunteers Latently Infected With TB.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00456183
Recruitment Status : Completed
First Posted : April 4, 2007
Last Update Posted : May 31, 2007
Information provided by:
University of Oxford

Brief Summary:
This study is designed to evaluate the safety of MVA85A in healthy volunteers in the UK who are latently infected with M.tb. A single vaccination with MVA85A, when administeredat a dose of 5 x 107pfu intradermally, is safe in both mycobacterially naïve individuals and those previously vaccinated with BCG. We will use the same vaccination regime in this study. Subjects will be defined as being latently infected if they have a positive elispot response to ESAT6 or CFP10. Subjects will be identified from TB contact clinics.

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: MVA 85A Phase 1

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase I Study Evaluating the Safety and Immunogenicity of a New TB Vaccine, MVA85A, in Healthy Volunteers Who Are Latently Infected With Mycobacterium Tuberculosis.
Study Start Date : August 2005
Actual Study Completion Date : April 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis

Primary Outcome Measures :
  1. Safety of a single intradermal injection of 5 x 107pfu MVA85A [ Time Frame: One year ]

Secondary Outcome Measures :
  1. Efficacy [ Time Frame: One year ]
  2. latently infected with MVA85A on the immune response, both to antigen 85A (the antigen in
  3. the vaccine) and to ESAT6/CFP10 antigens (M.tb specific).
  4. Endpoints:
  5. The specific endpoints for safety and reactogenicity will be actively and passively collected
  6. data on adverse events (AEs). The specific endpoints for immunogenicity will be markers of
  7. cell-mediated immunity as described below.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria

  • Healthy adults aged 18 to 50 years
  • Resident in or near Oxford for the duration of the vaccination study
  • Willingness to allow the investigators to discuss the volunteer's medical history with the volunteer's GP
  • Screening Elispot positive (more than 50 spots/million PBMC) for at least any 1 of the 3 ESAT6 peptide pools or any one of the 3 CFP10 pools ; and screening Elispot positive for PPD.
  • Heaf test grade II-IV or positive Mantoux test.
  • CXR normal; or abnormal but not clinically significant CXR findings with no evidence of past/present TB infection or disease on the CXR.
  • For females only, willingness to practice continuous effective contraception during the study and a negative pregnancy test on the day of vaccination
  • Agreement to refrain from blood donation during the course of the study
  • Written informed consent
  • Willingness to undergo an HIV

Exclusion Criteria

  • Any deviation from the normal range in biochemistry or haematology blood tests or in urine analysis
  • Heaf grade IV
  • Prior receipt of a recombinant MVA or Fowlpox vaccine
  • Use of any investigational or non-registered drug, live vaccine or medical device other than the study vaccine within 30 days preceding dosing of study vaccine, or planned use during the study period
  • Administration of chronic (defined as more than 14 days) immunosuppressive drugs or other immune modifying drugs within six months of vaccination. (For corticosteroids, this will mean prednisolone, or equivalent, ε 0.5 mg/kg/day. Inhaled and topical steroids are allowed.)
  • Any confirmed or suspected immunosuppressive or immunodeficient condition, including human immunodeficiency virus (HIV) infection and asplenia
  • History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products
  • Evidence of cardiovascular disease
  • History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ)
  • History of insulin requiring diabetes mellitus
  • Chronic or active neurological disease requiring ongoing specialist supervision

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00456183

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

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00456183    
Other Study ID Numbers: TB007
First Posted: April 4, 2007    Key Record Dates
Last Update Posted: May 31, 2007
Last Verified: May 2007
Keywords provided by University of Oxford:
Additional relevant MeSH terms:
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Mycobacterium Infections
Actinomycetales Infections
Gram-Positive Bacterial Infections
Bacterial Infections