Tuberculosis Clinical Trial
Official title:
Measurement of Human T−Cell Turnover Following Vaccination With the Tuberculosis Vaccine MVA85A
This study examines the early immune response to a new vaccine (MVA85A) being developed to combat tuberculosis (TB).
Status | Completed |
Enrollment | 12 |
Est. completion date | January 2010 |
Est. primary completion date | January 2010 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 50 Years |
Eligibility |
Inclusion Criteria: - Healthy adult aged 18 to 50 years - Immunization with BCG greater than 12 months prior to enrolment in the study - Resident in or near Oxford for the duration of the study - Able and willing (in the investigator's opinion) to comply with all study requirements - Given written informed consent - Willing to allow the investigator to request medical information from, or discuss the volunteer's medical history with the volunteer's General Practitioner - Willing to allow the investigator to register volunteer details with a confidential database to prevent concurrent entry into clinical trials - For women only, willingness to practice continuous effective contraception during the study - Agreement to refrain from blood donation during the course of the study Exclusion Criteria: Participation in another research study involving an investigational product in the 30 days preceding enrolment, or planned use during the study period - Prior receipt of a recombinant MVA vaccine - Screening test suggesting the possibility of latent TB infection- i.e. Elispot positive (greater than 17 sfc/million PBMC) in any ESAT6 peptide or CFP10 peptide pool - Any clinically significant abnormal finding on screening blood tests or urinalysis (see Appendix B for guidance on study reference ranges) - Administration of immunoglobulins and/or any blood products within the three months preceding the planned administration of the vaccine candidate - Any confirmed or suspected immunosuppressive or immunodeficient state, including HIV infection; asplenia; recurrent severe infections and chronic (more than 14 days) immunosuppressant medication within the past 6 months (inhaled and topical steroids are allowed) - History of allergic disease or reactions likely to be exacerbated by any component of the vaccine, e.g. egg products - Any history of anaphylaxis - History of cancer (except basal cell carcinoma of the skin and cervical carcinoma in situ) - History of serious psychiatric condition - Suspected or known current alcohol abuse as defined by an alcohol intake of greater than 42 units every week - Seropositive for hepatitis B surface antigen (HBsAg) or hepatitis C virus (antibodies to HCV) - Pregnancy, lactation or willingness/intention to become pregnant during the study - Any other chronic illness requiring hospital specialist supervision - Any other significant disease, disorder or finding, which, in the opinion of the investigator, may either put the volunteer at risk because of participation in the study, or may influence the result of the study, or the volunteer's ability to participate fully in the study |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United Kingdom | University of Oxford | Oxford | Oxfordshire |
Lead Sponsor | Collaborator |
---|---|
University of Oxford | St George's, University of London, Wellcome Trust |
United Kingdom,
Asquith B, Zhang Y, Mosley AJ, de Lara CM, Wallace DL, Worth A, Kaftantzi L, Meekings K, Griffin GE, Tanaka Y, Tough DF, Beverley PC, Taylor GP, Macallan DC, Bangham CR. In vivo T lymphocyte dynamics in humans and the impact of human T-lymphotropic virus 1 infection. Proc Natl Acad Sci U S A. 2007 May 8;104(19):8035-40. Epub 2007 May 1. — View Citation
Macallan DC, Wallace D, Zhang Y, De Lara C, Worth AT, Ghattas H, Griffin GE, Beverley PC, Tough DF. Rapid turnover of effector-memory CD4(+) T cells in healthy humans. J Exp Med. 2004 Jul 19;200(2):255-60. Epub 2004 Jul 12. — View Citation
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. — View Citation
Vukmanovic-Stejic M, Zhang Y, Cook JE, Fletcher JM, McQuaid A, Masters JE, Rustin MH, Taams LS, Beverley PC, Macallan DC, Akbar AN. Human CD4+ CD25hi Foxp3+ regulatory T cells are derived by rapid turnover of memory populations in vivo. J Clin Invest. 2006 Sep;116(9):2423-33. Erratum in: J Clin Invest. 2006 Oct;116(10):2829-30. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Proliferation and disappearance rates of responding antigen-specific T-cells | Within four weeks of vaccination | No | |
Secondary | Immunogenicity | Within three months of vaccination | No | |
Secondary | Safety | Within three months of vaccination | Yes |
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