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A Phase I Study of the Safety and Immunogenicity of MVA85A in Healthy Gambian Volunteers

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.
ClinicalTrials.gov Identifier: NCT00423839
Recruitment Status : Completed
First Posted : January 18, 2007
Last Update Posted : January 18, 2007
Sponsor:
Information provided by:
University of Oxford

Brief Summary:
A Phase I study of the Safety and immunogenicity of MVA85A in healthy Gambian volunteers

Condition or disease Intervention/treatment Phase
Tuberculosis Biological: MVA85A (Tuberculosis vaccine) Phase 1

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Phase I Study of the Safety and Immunogenicity of MVA85A in Healthy Gambian Volunteers
Study Start Date : March 2003
Estimated Study Completion Date : July 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Tuberculosis
U.S. FDA Resources




Primary Outcome Measures :
  1. Safety of the Vaccine. This will be determined by the degree and number of adverse events reported.

Secondary Outcome Measures :
  1. Immunogenicity of this vaccine. It is expected that the vaccine will stimulate T cell responses, which will be measured by interferon –gamma Elispot assays.


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Healthy adult male aged 18-45 years.
  • Normal medical history and physical examination. Minor physical ailments e.g. Fungal skin infections, will not be sufficient to define a physical examination as abnormal.
  • Normal urine dipstick, blood count, liver enzymes, and creatinine
  • Frequency <4 SFU per/well/3x105 PBMC as determined by ELISPOT with ESAT6/CFP-10 antigens and less than 100 SFU per/well/1x106 PBMC as determined by ELISPOT with PPD.
  • Mantoux negative (0.0 mm induration).
  • Normal Chest X-ray.
  • Willing to donate blood samples as required by the protocol

Exclusion Criteria:

  • Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease or neurological illness.
  • Any clinical evidence of immunosuppression such as oral candida, stomatitis, aphthous or septic ulceration, septic skin lesions or any clinical or laboratory evidence of infection or immunocompromise.
  • History of splenectomy
  • Haematocrit of less than 30%
  • Serum creatinine concentration >130mmol
  • Serum ALT concentration >80IU/L
  • Blood transfusion within one month of the beginning of the study
  • History of vaccination with any previous experimental poxvirus vaccine
  • Administration of any other vaccine or immunoglobulin within two weeks before or two weeks after vaccination.
  • Positive HIV antibody test, evidence of HBV (Hepatitis B vaccination is not an exclusion criteria)..
  • Current participation in another clinical trial, or within 12 weeks of this study
  • Any other finding which in the opinion of the investigators would increase the risk of an adverse outcome from participation in the trial.
  • Likelihood of travel away from the study area for the duration of the study
  • Untreated malaria infection

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 ClinicalTrials.gov identifier (NCT number): NCT00423839


Locations
Gambia
MRC Labs
Fajara, Gambia
Sponsors and Collaborators
University of Oxford
Investigators
Principal Investigator: Helen McShane, MD and PhD University of Oxford

Publications:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00423839     History of Changes
Other Study ID Numbers: AFTBVAC
First Posted: January 18, 2007    Key Record Dates
Last Update Posted: January 18, 2007
Last Verified: December 2006

Keywords provided by University of Oxford:
Mycobacterium tuberculosis
Antigen 85A
Modified Vaccinia Virus Ankara (MVA).

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