A Phase I Study of the Safety and Immunogenicity of MVA85A in Healthy Gambian Volunteers - Full Text View

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:

MedlinePlus related topics: Tuberculosis

U.S. FDA Resources

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

Eligibility

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

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 May 23, 2013