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| Name | Class |
|---|---|
| University of Birmingham | OTHER |
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This is a Phase I trial to evaluate the safety and immunogenicity of a ChAdOx1 85A vaccination with and without MVA85A boost in healthy BCG vaccinated adults.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Starter Group | Experimental | The first six volunteers will receive one dose of 5x10^9vp of ChAdOx1 85A intramuscular injection. |
|
| Group A | Experimental | 12 subjects will receive one dose of 2.5x10^10vp of ChAdOx1 85A intramuscular injection. |
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| Group B | Experimental | 12 subjects will receive one dose of 2.5x10^10vp of ChAdOx1 85A by intramuscular injection, followed by a boost dose of 1x10^8pfu of MVA85A by intramuscular injection 56 days later. |
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| Group C | Experimental | 12 subjects will receive two doses of 2.5x10^10vp of ChAdOx1 85A by intramuscular injection at day 0 and day 28, followed by a boost dose of 1x10^8pfu of MVA85A by intramuscular injection at day 119. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ChAdOx1 85A | Biological | Intramuscular injection |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety of ChAdOx1 85A vaccination with, and without, MVA85A boost vaccination in healthy, BCG vaccinated adults. | To evaluate the safety in healthy BCG-vaccinated subjects of ChAdOx1 85A vaccination, with and without MVA85A boost vaccination, by actively and passively collecting data on adverse events. | Six months following vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| To investigate the T-cell immune response of ChAdOx1 85A vaccination compared with ChAdOx1 85A vaccination with MVA85A boost vaccination. | To evaluate the systemic and mucosal cellular immunogenicity in healthy BCG-vaccinated subjects of ChAdOx1 85A vaccination, compared with ChAdOx1 85A vaccination with MVA85A boost vaccination, by comparing laboratory markers of cell mediated immunity in blood. |
| Measure | Description | Time Frame |
|---|---|---|
| To conduct further exploratory immunological analyses on samples from vaccinees in this trial. | Six months following vaccination |
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 |
|---|---|---|---|
| 32934758 | Derived | Crisan-Dabija R, Grigorescu C, Pavel CA, Artene B, Popa IV, Cernomaz A, Burlacu A. Tuberculosis and COVID-19: Lessons from the Past Viral Outbreaks and Possible Future Outcomes. Can Respir J. 2020 Sep 5;2020:1401053. doi: 10.1155/2020/1401053. eCollection 2020. |
| Label | URL |
|---|---|
| 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 |
|---|---|
| C549320 | MVA 85A |
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| MVA85A | Biological | Intramuscular injection |
|
| Six months following vaccination |
| The NIHR/ Wellcome Trust Clinical Research Facility, University of Birmingham |
| Birmingham |
| West Midlands |
| B15 2TB |
| United Kingdom |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |