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Healthy volunteers will receive a 2-dose vaccination with Shigella dysenteriae candidate vaccine spaced 8 weeks apart. The objective is to demonstrate the safety and reactogenicity of the Shigella dysenteriae bioconjugate vaccine (GVXN SD133) alone or in combination with an adjuvant (Aluminium Hydroxide). The safety and reactogenicity of the GVXN SD133 vaccine will be also evaluated at two different concentrations of antigen, Shigella polysaccharide O1. Blood samples will be collected at intervals to examine systemic vaccine antigen-specific immune responses.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HHD O1-EPA plus adjuvant | Experimental | 10 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA adjuvanted to aluminium hydroxide |
|
| HHD O1-EPA | Experimental | 10 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA |
|
| LHD O1-EPA adjuvanted | Experimental | 2 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA adjuvanted to aluminium hydroxide |
|
| LHD O1-EPA | Experimental | 2 ug of Shigella dysenteriae polysaccharide O1 conjugated to EPA |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Shigella vaccine | Biological | Two intramuscular injections of bioconjugate vaccine will be administrated at D0 and D60. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Safety and reactogenicity of the bioconjugate vaccine, GVXN SD133 | Each study visits and at the and of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Humoral immunogenicity | at day 0, 30, 60, 90 and 150 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christoph Hatz, Prof. Dr. | Institute of Social and Preventive Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Institute of Social and Preventive Medicine | Zurich | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26162850 | Derived | Hatz CF, Bally B, Rohrer S, Steffen R, Kramme S, Siegrist CA, Wacker M, Alaimo C, Fonck VG. Safety and immunogenicity of a candidate bioconjugate vaccine against Shigella dysenteriae type 1 administered to healthy adults: A single blind, partially randomized Phase I study. Vaccine. 2015 Aug 26;33(36):4594-601. doi: 10.1016/j.vaccine.2015.06.102. Epub 2015 Jul 7. |
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| ID | Term |
|---|---|
| D004405 | Dysentery, Bacillary |
| ID | Term |
|---|---|
| D004756 | Enterobacteriaceae Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
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| ID | Term |
|---|---|
| D022281 | Shigella Vaccines |
| ID | Term |
|---|---|
| D001428 | Bacterial Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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| D007239 | Infections |
| D004403 | Dysentery |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |