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Sponsors and Collaborators: |
St George's, University of London Statens Serum Institut Novartis Vaccines Commission of the European Union |
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Information provided by: | St George's, University of London |
ClinicalTrials.gov Identifier: | NCT00440544 |
The purpose of this study is to determine whether a subunit tuberculosis vaccine given as two nasal immunizations composed of a hybrid protein antigen from M. tuberculosis virus mixed with a toxoid adjuvant, causes untoward adverse reactions when administered to healthy adult volunteers. Both subjects who have not received Bacillus Calmette-Guerin (BCG) and subjects who have already received BCG will be enrolled. An initial evaluation of immune responses to the vaccine will also be undertaken.
Condition | Intervention | Phase |
---|---|---|
Tuberculosis |
Biological: Ag85B-ESAT6 fusion protein H1 |
Phase I |
Study Type: | Interventional |
Study Design: | Prevention, Non-Randomized, Open Label, Active Control, Parallel Assignment, Safety Study |
Official Title: | A Phase I Trial of the Safety and Immunogenicity of an Adjuvated TB Subunit Vaccine (Ag85B-ESAT6 + LTK63) Administered at 0 and 2 Months |
Enrollment: | 9 |
Study Start Date: | January 2007 |
Study Completion Date: | February 2008 |
Primary Completion Date: | November 2007 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
---|---|
1: Experimental
100 ug H1 antigen alone in BCG naive subjects
|
Biological: Ag85B-ESAT6 fusion protein H1
100 ug H1 antigen in BCG naive subjects
|
2: Experimental
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
|
Biological: Ag85B-ESAT6 fusion protein H1
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG naive subjects
|
3: Experimental
50 ug H1 antigen in BCG immunized subjects
|
Biological: Ag85B-ESAT6 fusion protein H1
50 ug H1 antigen in BCG immunized subjects
|
4: Experimental
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
Biological: Ag85B-ESAT6 fusion protein H1
50 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
5: Experimental
100 ug H1 antigen in BCG immunized subjects
|
Biological: Ag85B-ESAT6 fusion protein H1
100 ug H1 antigen in BCG immunized subjects
|
6: Experimental
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
Biological: Ag85B-ESAT6 fusion protein H1
100 ug H1 antigen + LTK63 adjuvant 30 ug in BCG immunized subjects
|
The purpose of this study is to determine whether a subunit tuberculosis vaccine given as two nasal immunizations composed of a hybrid protein antigen from M. tuberculosis virus mixed with a toxoid adjuvant, causes untoward adverse reactions when administered to healthy adult volunteers. Both subjects who have not received BCG and subjects who have already received BCG will be enrolled. An initial evaluation of immune responses to the vaccine will also be undertaken using flow cytometry to enumerate antigen specific IFNg containing T cells; ELISPOT to determine IFNg secreting antigen specific T cells; serology and nasal wash antibody.
Ages Eligible for Study: | 18 Years to 55 Years |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Additional inclusion criterion for BCG-non-vaccinated subjects:
Additional inclusion criterion for BCG-vaccinated subjects:
Exclusion Criteria:
United Kingdom, England | |
St George's Vaccine Institute | |
London, England, United Kingdom, SW17 0RE |
Principal Investigator: | David JM Lewis, MD | St George's, University of London, UK |
Responsible Party: | SGUL ( David JM Lewis, Principal Investigator ) |
Study ID Numbers: | TMUVA-01, EudraCT Number: 2005-005140-81, FP6-2002-LIFESCIHEA-2.3 503240 |
Study First Received: | February 26, 2007 |
Last Updated: | October 31, 2008 |
ClinicalTrials.gov Identifier: | NCT00440544 |
Health Authority: | United Kingdom: Research Ethics Committee; United Kingdom: Medicines and Healthcare Products Regulatory Agency |
Tuberculosis vaccine nasal immunization |
Bacterial Infections Gram-Positive Bacterial Infections Mycobacterium Infections Tuberculosis |
Actinomycetales Infections |