Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study aims to assess antibody persistence induced by Spirolept® vaccination in subjects who received at least 4 doses (2 doses two weeks apart and 2 booster doses) and no more than a total of 8 doses (2 doses two weeks apart and 6 booster doses).
This is a seroprevalence, phase IV, multi -center study to evaluate anti-Leptospira antibody persistence in subjects who have received at least the 2nd booster (4 vaccine doses) and no more than the 6th booster (8 vaccine doses) of Spirolept® vaccine.
The study will be conducted at the Occupational Health Centre of companies employing workers at risk of leptospirosis for their occupational activities. Study participants will be selected from the company Occupational Health Centre database where each employee is registered. All workers are regularly followed-up and their medical and vaccination history recorded. Subjects selection will occur according the number of booster doses received (having received at least the 2nd booster and no more than the 6th booster). After they have signed the informed consent form, subjects will be recruited into the study and if all inclusion and exclusion criteria are met they will be taken a blood sample.
Anti-leptospira IgG antibody will be measured by a validated ELISA. Other assay may be performed to further characterize anti-leptospira antibodies. Data on subject demographics, relevant medical history, vaccination dates, and blood collection will be recorded in an appropriate Case Report Form.
The study does not include any vaccination.
Not provided
Not provided
Not provided
Not provided
Not provided
| Measure | Description | Time Frame |
|---|---|---|
| ELISA immunoglobulin G (IgG) anti-leptospire | Proportion of subjects seropositive to ELISA IgG anti-leptospira (with cut-off antibody titer ≥ 20) at different time points after the last booster dose | through study completion, an average of 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| ELISA IgG geometric mean titer (GMTs) | Proportion of subjects seropositive to ELISA IgG anti-leptospira (with cut-off antibody titer ≥ 20) and GMTs at different time points according to demographic factors and vaccination scheme | through study completion, an average of 8 months |
| Measure | Description | Time Frame |
|---|---|---|
| exploratory growth inhibition test (GIT) Test | Proportion of subjects with positive GIT (positive GIT: serum that provides ≥ 50% leptospira growth inhibition in the test) | through study completion, an average of 8 months |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
The study will be conducted at the Occupational Health Centre of companies employing workers at risk of leptospirosis for their occupational activities. Study participants will be selected from the company Occupational Health Centre database where each employee is registered. All workers are regularly followed-up and their medical and vaccination history recorded. Subjects selection will occur according the number of booster doses received (having received at least the 2nd booster and no more than the 6th booster).
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Maryse Beder, MD | SIAAP | Principal Investigator |
| Simonetta Viviani, MD | Imaxio | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| SIAAP | Maisons-Laffitte | 78603 | France | |||
| Mairie de Paris |
Not provided
| ID | Term |
|---|---|
| D007922 | Leptospirosis |
| ID | Term |
|---|---|
| D013145 | Spirochaetales Infections |
| D016905 | Gram-Negative Bacterial Infections |
| D001424 | Bacterial Infections |
| D001423 | Bacterial Infections and Mycoses |
Not provided
Not provided
Not provided
Not provided
Not provided
IgG, GIT are studied on serum
| Paris |
| 75013 |
| France |
| D007239 | Infections |