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

This study has been completed.
Sponsor:
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00456183
First received: April 3, 2007
Last updated: May 30, 2007
Last verified: May 2007
History of Changes
  Purpose

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 Intervention Phase
Tuberculosis
 Biological: MVA 85A
 Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources

Further study details as provided by University of Oxford:

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

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

Enrollment: 12
Study Start Date: August 2005
Study Completion Date: April 2007
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00456183

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

Publications:

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

ClinicalTrials.gov Identifier: NCT00456183     History of Changes
Other Study ID Numbers: TB007
Study First Received: April 3, 2007
Last Updated: May 30, 2007
Health Authority: United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:
Tuberculosis
Latent
TB
Vaccine
MVA 85A

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

ClinicalTrials.gov processed this record on May 23, 2013