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| Name | Class |
|---|---|
| MRC/UVRI and LSHTM Uganda Research Unit | OTHER |
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Mycobacterium tuberculosis (M. tb) is a pathogen with worldwide distribution which infects humans causing tuberculosis (TB), a transmissible disease resulting in very high mortality and morbidity; development of an effective vaccine is a global health priority.
Over a billion people worldwide are infected with one or more helminths. Helminths are parasitic worms, of which Schistosoma mansoni is one species. There is some evidence that helminth infection may affect a person's response to a vaccine. In this trial the investigators hope to investigate whether Schistosoma mansoni infection affects adolescents' responses to a candidate TB vaccine called MVA85A, as adolescents are a crucial target group for an effective TB vaccine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | Experimental | Group 1 (Schistosoma mansoni uninfected): 12-24 BCG-vaccinated volunteers with no helminth infection. Single dose of 1x10^8pfu MVA85A intramuscular vaccination at D0. |
|
| Group 2 | Experimental | Group 2 (Schistosoma mansoni infected): 12-24 BCG-vaccinated volunteers with helminth infection. Single dose of 1x10^8pfu MVA85A intramuscular vaccination at D0. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MVA85A | Biological | Single dose of 1x10^8pfu MVA85A intramuscular vaccination |
|
| Measure | Description | Time Frame |
|---|---|---|
| T cell immunogenicity by gamma-interferon ELISPOT of Ag85A response. | To compare T cell immunogenicity in adolescents with and without S. mansoni infection. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of cytokines in supernatant of stimulated cells using Luminex and flow cytometry of Ag85A response. | Effects of S. mansoni infection on other aspects of the immune response following MVA85A immunisation. | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Actively and passively collected data on adverse events. | To assess the safety of MVA85A vaccination in BCG-vaccinated African adolescents aged 12-17 years. | 8 weeks |
Inclusion Criteria
Participants must meet all of the following criteria to enter the trial:
Exclusion Criteria
Participants may not enter the trial if ANY of the following apply:
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| Name | Affiliation | Role |
|---|---|---|
| Helen McShane | University of Oxford | Study Director |
| Alison Elliot | MRC/UVRI and LSHTM Uganda Research Unit | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| MRC/UVRI Uganda Research Unit on AIDS | Entebbe | Uganda |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30687792 | Derived | Wajja A, Namutebi M, Apule B, Oduru G, Kiwanuka S, Akello M, Nassanga B, Kabagenyi J, Mpiima J, Vermaak S, Lawrie A, Satti I, Verweij J, Cose S, Levin J, Kaleebu P, Tukahebwa E, McShane H, Elliott AM. Lessons from the first clinical trial of a non-licensed vaccine among Ugandan adolescents: a phase II field trial of the tuberculosis candidate vaccine, MVA85A. Wellcome Open Res. 2018 Sep 19;3:121. doi: 10.12688/wellcomeopenres.14736.1. eCollection 2018. | |
| 28472067 |
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| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| D012552 | Schistosomiasis |
| 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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| Derived |
| Wajja A, Kizito D, Nassanga B, Nalwoga A, Kabagenyi J, Kimuda S, Galiwango R, Mutonyi G, Vermaak S, Satti I, Verweij J, Tukahebwa E, Cose S, Levin J, Kaleebu P, Elliott AM, McShane H. The effect of current Schistosoma mansoni infection on the immunogenicity of a candidate TB vaccine, MVA85A, in BCG-vaccinated adolescents: An open-label trial. PLoS Negl Trop Dis. 2017 May 4;11(5):e0005440. doi: 10.1371/journal.pntd.0005440. eCollection 2017 May. |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
| D014201 | Trematode Infections |
| D006373 | Helminthiasis |
| D010272 | Parasitic Diseases |
| D000079426 | Vector Borne Diseases |