Immune Response After Leptospirosis Infection

• Conditions: Leptospirosis

• Registration Number: NCT02898519
• Lead Sponsor: Centre Hospitalier Universitaire de la Réunion

Brief Summary

Leptospirosis is a zoonotic infection induced by pathogen bacteria (genus: Leptospira) growing in water polluted by animal fluids. Due to its 10 fold occurence in French overseas aera, and especially in Reunion Island, as compared to metropoly, it is considered as a major public health issue.

An important inter-individual variability in humoral immune response suggests that vaccination should be recommended in exposed subjects.

This cohort study aimed to determine if subjects that have been infected by leptospirosis for 1 to 7 years still remain immunized, and then do not need vaccination.

Detailed Description

Every year more than 500 000 severe forms of leptospirosis are diagnosed in Reunion Island. The risk of mucocutaneous contact with contaminated media remains important due to highly aqueous environment.

Cured subjects that have been infected for 1, 2, 3, 4, 5, 6 or 7 years will be enrolled. The qualitative and quantitative humoral immune response to leptospirosis infection will also be evaluated to determine whether they still get protective immunization. Leptospirosis immunization will be evaluated using micro-agglutination test.

Graded immune responses related to the severity and the length of the infection will also be investigated.

Finally, 3 methods used for leptospirosis diagnosis will be compared. It is expected from this study to evaluate the appropriate conditions in which new vaccination could be required to prevent further leptospirosis infection in cured subjects.

Study Timeline

• Status Verified: 2016-09
• Study First Submitted: 2016-09-08
• Study First Submitted QC: 2016-09-08
• Last Update Submitted: 2016-09-08
• Study First Posted: 2016-09-13
• Last Update Posted: 2016-09-13
• Study Start: 2016-10
• Primary Completion: 2017-12
• Study Completion: 2018-09

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 175

Inclusion Criteria

• Subjects diagnosed for leptospirosis by polymerase chain reaction measured in Reunion Island Hospital between 209-2015
• with social security issue

Exclusion Criteria

• Leptospirosis diagnosis not confirmed by polymerase chain reaction
• subject exhibiting immunodepressive status (cancers, transplantation, immune deficit, blood disorders)
• under medication: corticoids, immunosuppressor, chemiotherapy

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Leptospirosis immunization assessed by serum immunoglobulin	1-7 years after leptospirosis infection	Humoral immune response will be measured in serum cured-subjects using micro-agglutination test

Secondary Outcome Measures

Name	Time	Method
rate of still-immunized patients	1-7 years after leptospirosis infection	Seropositive subjects will be measured using the ELISA serion method and the ELISA recombinant protein method
comparison of 3 diagnosis method for leptospirosis	1-7 years after leptospirosis infection	Matched results of the 3 methods: micro-agglutination test, ELISA serion method and ELISA recombinant protein method will be compared