Leptospirosis Clinical Trial
— SPT-001Official title:
Seroprevalence, Multi-center, Phase IV Cross-sectional Study to Evaluate the Persistence of Anti-leptospira Antibody in Subjects Vaccinated With Spirolept® Vaccine
Verified date | May 2018 |
Source | Imaxio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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).
Status | Completed |
Enrollment | 145 |
Est. completion date | April 12, 2018 |
Est. primary completion date | April 12, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility |
Inclusion Criteria: - Adults of both genders aged 18 to 65 years - High risk occupational subjects to leptospirosis having received at least 4 (2 initial doses and 2 booster doses) and no more than 8 (2 first doses and 6 booster doses) doses of Spirolept® - Previous Spirolept® vaccination dates documented - To be affiliated to a health insurance plan - Having signed the informed consent form Exclusion Criteria: - Had an acute infection during the 3 weeks before study enrollment - Subject with documented HIV or hepatitis A, B, C - Immunosuppressive treatment (chemotherapy, corticosteroids > 20mg/day, biological agents) - Subject with progressive malignancy requiring specific treatment - Previous documented Leptospirosis |
Country | Name | City | State |
---|---|---|---|
France | SIAAP | Maisons-Laffitte | |
France | Mairie de Paris | Paris |
Lead Sponsor | Collaborator |
---|---|
Imaxio |
France,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | 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 | |
Primary | 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 | |
Secondary | 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 |
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