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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 September 18, 2014