A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers.

This study has been completed.

First Received: January 17, 2007 No Changes Posted

Sponsored by:	University of Oxford
Information provided by:	University of Oxford
ClinicalTrials.gov Identifier:	NCT00423566

Purpose

This study is to assesss the safety and immunogenicity of vaccine based on Modified Vaccinia Ankara (MVA) expressing the 85A antigen (from Mycobacterium.

tuberculosis). This vaccine is delivered intrdermally by a needle injection in healthy volunteers.

Condition	Intervention	Phase
Tuberculosis	Biological: MVA85A (Tuberculosis vaccine)	Phase I

Study Type:	Interventional
Study Design:	Prevention, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety Study
Official Title:	A Phase I Study of the Safety and Immunogenicity of a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy 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:

Local and systemic reactions will be monitored 30 and 60 minutes after administration.
A photograph of the injection will be taken at 48 hours and this injection site will be reviewed 7 days after each immunisation.
Blood will be taken: 1 week after the first vaccination, 1 week after the second vaccination and then at 4, 8, 12 and 24 weeks. The blood is used for a full blood count and biochemical screen.
Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay).

Secondary Outcome Measures:

Immunological assays are performed at all time points to determine vaccine imunogenicity (T cell responses are measured using an interferon-gamma Elispot assay).

Estimated Enrollment:	14
Study Start Date:	September 2002
Estimated Study Completion Date:	July 2003

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Eligibility

Ages Eligible for Study:	18 Years to 45 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adult aged 18-45 years.
Normal medical history and physical examination.
Normal urine dipstick, blood count, liver enzymes, and creatinine.

Exclusion Criteria:

Exposure to TB/BCG vaccination at any point. Previous residence in a TB endemic area.
Clinically significant history of skin disorder (eczema, psoriasis, etc.), allergy, immunodeficiency, cardiovascular disease, respiratory disease, endocrine disorder, liver disease, renal disease, gastrointestinal disease, neurological illness, psychiatric disorder, drug or alcohol abuse.
Oral or systemic steroid medication or the use of immunosuppressive agents.
Positive HIV antibody test, HCV antibody test or positive HBV serology except post-vaccination.
Positive Heaf test
Confirmed pregnancy
Previous MVA immunisations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00423566

Locations

United Kingdom, Oxfordshire
University of Oxford, Centre for Clinical Vaccinology and Tropical Medicine
Oxford, Oxfordshire, United Kingdom, OX3 7LJ

Sponsors and Collaborators

University of Oxford

Investigators

Principal Investigator:

Helen McShane, MD and PhD

University of Oxford

More Information

No publications provided

Study ID Numbers:	TB002
Study First Received:	January 17, 2007
Last Updated:	January 17, 2007
ClinicalTrials.gov Identifier:	NCT00423566 History of Changes
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by University of Oxford:

Mycobacterium tuberculosis
85A antigen
Recombinant Modified Vaccinia virus Ankara
Phase I study
Immunogenicity

Study placed in the following topic categories:

Bacterial Infections
Virus Diseases
Gram-Positive Bacterial Infections
Vaccinia

Mycobacterium Infections
Tuberculosis
Healthy

Additional relevant MeSH terms:

Bacterial Infections
Gram-Positive Bacterial Infections
Mycobacterium Infections
Tuberculosis
Actinomycetales Infections

ClinicalTrials.gov processed this record on July 06, 2009