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

This study has been completed.
Sponsor:
Information provided by:
University of Oxford
ClinicalTrials.gov Identifier:
NCT00423839
First received: January 17, 2007
Last updated: NA
Last verified: December 2006
History: No changes posted
  Purpose

A Phase I study of the Safety and immunogenicity of MVA85A in healthy Gambian 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 MVA85A in Healthy Gambian Volunteers

Resource links provided by NLM:


Further study details as provided by University of Oxford:

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

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

Estimated Enrollment: 12
Study Start Date: March 2003
Estimated Study Completion Date: July 2005
  Show Detailed Description

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00423839

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

Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
ClinicalTrials.gov Identifier: NCT00423839     History of Changes
Other Study ID Numbers: AFTBVAC
Study First Received: January 17, 2007
Last Updated: January 17, 2007
Health Authority: Gambia: MRC Ethics Committee

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

ClinicalTrials.gov processed this record on April 14, 2014