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The purpose of this study is to evaluate the safety profile of an adjuvanted TB subunit vaccine administered at 0 and 2 months.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Latent TB infection group | Experimental | The latent TB group will receive two injections of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart. |
|
| BCG vaccinated group | Experimental | The BCG vaccinated group will receive two vaccinations of 50 microgram antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a)two months apart |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a) | Biological | o,5 mL suspension for injection x 2 with 2 months interval |
|
| Measure | Description | Time Frame |
|---|---|---|
| Physical examination. Local adverse events.Systemic adverse events. Laboratory safety tests including urine safety tests. | From first vaccination until 8 months after the first vaccination |
| Measure | Description | Time Frame |
|---|---|---|
| Detection by ELISPOT of IFNgamma spot-forming cells in PBMCs. Detection by ELISA of IFNgamma production in supernatants of PBMC. Detection by ELISA of IgG antibodies in serum/plasma. Detection by Elisa of TNFalfa and IFNgamma in serum | From first vaccination until 8 months after first vaccination |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jaap van Dissel, MD, Prof. | Leiden University Medical Centre | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Leiden University Medical Centre | Leiden | RC Leiden | 2300 | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21256189 | Derived | van Dissel JT, Soonawala D, Joosten SA, Prins C, Arend SM, Bang P, Tingskov PN, Lingnau K, Nouta J, Hoff ST, Rosenkrands I, Kromann I, Ottenhoff TH, Doherty TM, Andersen P. Ag85B-ESAT-6 adjuvanted with IC31(R) promotes strong and long-lived Mycobacterium tuberculosis specific T cell responses in volunteers with previous BCG vaccination or tuberculosis infection. Vaccine. 2011 Mar 3;29(11):2100-9. doi: 10.1016/j.vaccine.2010.12.135. Epub 2011 Jan 20. |
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| 50 microg. antigen + adjuvant (500 nmol KLK + 20 nmol ODN1a) | Biological | o,5 mL suspension for injection x 2 with 2 months interval |
|
|
| ID | Term |
|---|---|
| D014376 | Tuberculosis |
| ID | Term |
|---|---|
| D009164 | Mycobacterium Infections |
| D000193 | Actinomycetales Infections |
| D016908 | Gram-Positive Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D000277 | Adjuvants, Pharmaceutic |
| C544002 | IC31 adjuvant |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
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