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This is a phase I trial to compare the safety and immunogenicity of candidate TB vaccine MVA85A administered by the aerosol inhaled route and the intradermal route in healthy BCG-vaccinated adult subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Aerosol inhaled MVA85A and intradermal saline placebo |
|
| Group 2 | Experimental | Intradermal MVA85A and inhaled aerosol saline placebo |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aerosol inhaled MVA85A | Biological | Aerosol inhaled MVA85A 1 x 10^7 pfu and intradermal saline placebo |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of MVA85A vaccination by the aerosol inhaled route | To evaluate the safety in healthy BCG-vaccinated subjects of MVA85A vaccination by the aerosol inhaled route by actively and passively collecting data on adverse events | 24 weeks following vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of MVA85A vaccination by the aerosol inhaled route compared with the intradermal route | To evaluate the systemic and mucosal cellular immunogenicity in healthy BCG-vaccinated subjects of MVA85A vaccination by the aerosol inhaled route compared with the intradermal route by comparing laboratory markers of cell mediated immunity in blood and bronchoalveolar lavage samples | 24 weeks following vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Helen McShane | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre of Clinical Vaccinology and Tropical Medicine (CCVTM) Churchill Hospital | Oxford | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25151225 | Derived | Satti I, Meyer J, Harris SA, Manjaly Thomas ZR, Griffiths K, Antrobus RD, Rowland R, Ramon RL, Smith M, Sheehan S, Bettinson H, McShane H. Safety and immunogenicity of a candidate tuberculosis vaccine MVA85A delivered by aerosol in BCG-vaccinated healthy adults: a phase 1, double-blind, randomised controlled trial. Lancet Infect Dis. 2014 Oct;14(10):939-46. doi: 10.1016/S1473-3099(14)70845-X. Epub 2014 Aug 20. |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
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| Intradermal MVA85A | Biological | Intradermal MVA85A 1 x 10^7 pfu and inhaled aerosol saline placebo |
|
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |