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The purpose of this study is to assess the immune response produced by two doses of SC599 vaccine compared to placebo.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| SC599 | Biological |
| Measure | Description | Time Frame |
|---|---|---|
| Immune response assessed by the proportion of Immunoglobulin A (IgA) anti-Lipopolysaccharide (LPS) Antibody-Secreting Cells (ASC) responders. |
| Measure | Description | Time Frame |
|---|---|---|
| 1) Immune Response: | ||
| -Proportion of volunteers who have a B subunit antibody response | ||
| -Proportion of volunteers who have a LPS response |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dr Odile Launay, MD | Hôpital Cochin - Bâtiment Modulaire, France | Principal Investigator |
| Dr David Lewis, MD | St George's Hospital Vaccine Institute, UK | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CIC de Vaccinologie Cochin Pasteur | Paris | 75014 | France | |||
| Dept of Cellular and Molecular Medicine, St George's Hospital Vaccine Institute |
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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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| 2) SC599 Shedding |
| -Proportion of volunteers who will excrete the vaccine strain and by the duration of the SC5999 shedding, defined as the time (days) between the first an last stool that were positive for SC599. |
| 3) Safety Assessment |
| -The safety will be evaluated by the proportions of clinical and biological adverse events. Illness after vaccination will be defined as either diarrhoea or fever. |
| London |
| SW17 0QT |
| United Kingdom |
| D007239 | Infections |
| D004403 | Dysentery |
| D005759 | Gastroenteritis |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007410 | Intestinal Diseases |