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Immune Response After Leptospirosis Infection

Serological Response in Patients Infected by Leptospirosis 1 to 7 Years Earlier

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02898519
Acronym
SERO7LEPTO
Enrollment
175
Registered
2016-09-13
Start date
2016-10-31
Completion date
2018-09-30
Last updated
2016-09-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Leptospirosis

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.

Interventions

OTHERcohort

Blood sampling

Sponsors

Institut Pasteur
CollaboratorINDUSTRY
Centre Hospitalier Universitaire de la Réunion
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Leptospirosis immunization assessed by serum immunoglobulin1-7 years after leptospirosis infectionHumoral immune response will be measured in serum cured-subjects using micro-agglutination test

Secondary

MeasureTime frameDescription
rate of still-immunized patients1-7 years after leptospirosis infectionSeropositive subjects will be measured using the ELISA serion method and the ELISA recombinant protein method
comparison of 3 diagnosis method for leptospirosis1-7 years after leptospirosis infectionMatched results of the 3 methods: micro-agglutination test, ELISA serion method and ELISA recombinant protein method will be compared

Contacts

Primary ContactCHRISTINE JUHEL, PHD
christine.juhel@chu-reunion.fr+262262359949

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026