CompletedNot Applicable

Seroprevalence Study to Evaluate the Persistence of Anti-leptospira Antibody in Subjects Vaccinated With Spirolept® Vaccine

France145 participantsStarted 2017-08-25

Plain-language summary

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).

Who can participate

Age range18 Years – 65 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

ELISA immunoglobulin G (IgG) anti-leptospire

Timeframe: through study completion, an average of 8 months

Trial details

NCT IDNCT03497572

SponsorImaxio

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2018-04-12

View on ClinicalTrials.gov More Leptospirosis trials