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| Name | Class |
|---|---|
| Aeras | OTHER |
| Crucell Holland BV | INDUSTRY |
| Emergent BioSolutions | INDUSTRY |
| University of Birmingham |
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This trial will investigate the administration of two new tuberculosis vaccines, called AERAS-402 and MVA85A. The purpose of this trial is to assess what happens when both of these vaccines are given one after the other. The trial will assess the safety of both vaccines and also their ability to stimulate an immune response within the body. It is hoped that when these two vaccines are given in sequence, the combined immune response is even better than when each vaccine is used individually.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Two doses of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection) |
|
| Group B | Experimental | One dose of AERAS-402 (1x10^11 vp intramuscular injection) followed by one dose of MVA85A (1x10^8 pfu intradermal injection) |
|
| Group C | Experimental | Three doses of AERAS-402 (1x10^11 vp intramuscular injection) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| AERAS-402 | Biological | Intramuscular needle injection 1x10^11 vp |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of AERAS-402 followed by MVA85A | To evaluate the safety profile of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults, measured by number and severity of local and systemic adverse events | 3 months after final vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Immunogenicity of AERAS-402 followed by MVA85A | To evaluate and compare the immune responses as described by flow cytometric intracellular cytokine staining, antibody serology, and Elispot assays of multiple doses of AERAS-402 alone, compared to one and two doses of AERAS-402 followed by MVA85A in healthy, BCG vaccinated adults | 12-18 months after first vaccination |
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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 (CCVTM), Churchill Hospital | Oxford | Oxfordshire | OX3 7LE | United Kingdom | ||
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26529238 | Derived | Sheehan S, Harris SA, Satti I, Hokey DA, Dheenadhayalan V, Stockdale L, Manjaly Thomas ZR, Minhinnick A, Wilkie M, Vermaak S, Meyer J, O'Shea MK, Pau MG, Versteege I, Douoguih M, Hendriks J, Sadoff J, Landry B, Moss P, McShane H. A Phase I, Open-Label Trial, Evaluating the Safety and Immunogenicity of Candidate Tuberculosis Vaccines AERAS-402 and MVA85A, Administered by Prime-Boost Regime in BCG-Vaccinated Healthy Adults. PLoS One. 2015 Nov 3;10(11):e0141687. doi: 10.1371/journal.pone.0141687. eCollection 2015. |
| Label | URL |
|---|---|
| The Jenner Institute - Clinical Trials | 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 |
|---|---|
| C000592463 | AERAS-402 |
| C549320 | MVA 85A |
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| OTHER |
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| MVA85A | Biological | Intradermal needle injection 1x10^8 pfu |
|
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| The Wellcome Trust Clinical Research Facility (WTCRF), University of Birmingham |
| Birmingham |
| West Midlands |
| B15 2TH |
| United Kingdom |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |