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 Who Have Previously Received BCG - Full Text View

Purpose

This is a phase I study to examine the safety and immunogenicity of MVA85A delivered intradermally into the deltoid region in volunteers who have recieved BCG in the past 20 years.

Condition	Intervention	Phase
Tuberculosis	Biological: MVA85A	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 a Recombinant MVA Vaccine Encoding a Secreted Antigen From M. Tuberculosis, Antigen 85A, Delivered Intradermally by a Needle Injection in Healthy Volunteers Who Have Previously Received BCG

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:

The occurance and severity of local and systemic side effects will be monitored. Vital signs and local reactions will be monitored at 30 and 60 minutes after each immunisation (and after 7 days).

Secondary Outcome Measures:

Immunogenicity will be measured: The induction of T cell responses (as measured by an interferon-gamma Elispot assay) will be performed on PBMCs from blood samples taken at the specified time points.
Proliferation assays and cytotoxic T cell assays will be performed on strong CD4+ and CD8+ responses respectively.
Antibody titres will be measured from frozen plasma samples.

Estimated Enrollment:	16
Study Start Date:	May 2003
Estimated Study Completion Date:	January 2005

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Eligibility

Ages Eligible for Study:	18 Years to 55 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

Healthy adult aged 18-55 years.
Normal medical history and physical examination.
Normal urine dipstick, blood count, liver enzymes, and creatinine.

Exclusion Criteria:

Exposure to TB 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.
Heaf test greater than Grade II
Confirmed pregnancy
Previous MVA immunisations

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00427830

Locations

United Kingdom
Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford, Churchill Hospital
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

Publications:

McShane H, Pathan AA, Sander CR, Keating SM, Gilbert SC, Huygen K, Fletcher HA, Hill AV. Recombinant modified vaccinia virus Ankara expressing antigen 85A boosts BCG-primed and naturally acquired antimycobacterial immunity in humans. Nat Med. 2004 Nov;10(11):1240-4. Epub 2004 Oct 24. Erratum in: Nat Med. 2004 Dec;10(12):1397.

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Whelan KT, Pathan AA, Sander CR, Fletcher HA, Poulton I, Alder NC, Hill AV, McShane H. Safety and immunogenicity of boosting BCG vaccinated subjects with BCG: comparison with boosting with a new TB vaccine, MVA85A. PLoS One. 2009 Jun 16;4(6):e5934.

Pathan AA, Sander CR, Fletcher HA, Poulton I, Alder NC, Beveridge NE, Whelan KT, Hill AV, McShane H. Boosting BCG with recombinant modified vaccinia ankara expressing antigen 85A: different boosting intervals and implications for efficacy trials. PLoS ONE. 2007 Oct 24;2(10):e1052.

ClinicalTrials.gov Identifier:	NCT00427830 History of Changes
Other Study ID Numbers:	TB005
Study First Received:	January 25, 2007
Last Updated:	January 26, 2007
Health Authority:	United Kingdom: Medicines and Healthcare Products Regulatery Agency

Keywords provided by University of Oxford:

Mycobacterium tuberculosis
85A antigen
Recombinant Modified Vaccinia Ankara

Phase I study
Immunogenicity
BCG

Additional relevant MeSH terms:

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

ClinicalTrials.gov processed this record on May 19, 2013