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| Name | Class |
|---|---|
| Imaxio | INDUSTRY |
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This is a Phase I trial to evaluate the safety and immunogenicity of MVA85A-IMX313 vaccination compared to MVA85A vaccination, in BCG vaccinated adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | The first six volunteers will receive an intradermal injection of 1x10^7 pfu MVA85A-IMX313 (non-randomised). |
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| Group B | Active Comparator | 12 subjects receiving intradermal injection of 5x10^7 pfu MVA85A-IMX313 (following completion of group A, subjects will be randomised to either group B or group C). |
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| Group C | Active Comparator | 12 subjects receiving intradermal injection of 5x10^7 pfu MVA85A (following completion of group A, subjects will be randomised to either group B or group C). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVA85A-IMX313 | Biological | Intradermal injection of MVA85A-IMX313 (MVA85A-IMX313 combines the candidate TB vaccine MVA85A with the carrier protein IMX313) |
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| Measure | Description | Time Frame |
|---|---|---|
| Safety evaluation through actively and passively collected data on adverse events | To evaluate the safety in healthy BCG-vaccinated subjects of MVA85A-IMX313 vaccination compared to MVA85A vaccination, by actively and passively collecting data on adverse events. | Up to 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of immune response of MVA85A-IMX313 vaccination compared with MVA85A vaccination in healthy, BCG vaccinated adults. | To evaluate the immune response in healthy BCG-vaccinated subjects of MVA85A-IMX313 vaccination, compared with MVA85A vaccination, by comparing laboratory markers of cell mediated immunity in blood. | Up to 24 weeks |
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Inclusion Criteria:
Subjects must meet all of the following criteria to enter the trial:
Exclusion Criteria:
Subjects must meet none of the following criteria to enter the trial:
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| Name | Affiliation | Role |
|---|---|---|
| Helen McShane | University of Oxford | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centre for Clinical Vaccinology and Tropical Medicine, University of Oxford | Oxford | Oxfordshire | OX3 7LE | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26854906 | Derived | Minhinnick A, Satti I, Harris S, Wilkie M, Sheehan S, Stockdale L, Manjaly Thomas ZR, Lopez-Ramon R, Poulton I, Lawrie A, Vermaak S, Le Vert A, Del Campo J, Hill F, Moss P, McShane H. A first-in-human phase 1 trial to evaluate the safety and immunogenicity of the candidate tuberculosis vaccine MVA85A-IMX313, administered to BCG-vaccinated adults. Vaccine. 2016 Mar 8;34(11):1412-21. doi: 10.1016/j.vaccine.2016.01.062. Epub 2016 Feb 5. |
| Label | URL |
|---|---|
| Jenner Institute, University of Oxford, Website | View source |
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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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| ID | Term |
|---|---|
| C549320 | MVA 85A |
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| MVA85A | Biological | Intradermal injection of MVA85A (recombinant Modified Vaccinia virus Ankara expressing the M. tb antigen 85A) |
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| Wellcome Trust Clinical Research Facility |
| Birmingham |
| B15 2TH |
| United Kingdom |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |