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

NCT ID: NCT03497572

Last Updated: 2018-05-08

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 145 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-08-25
• Study Completion Date: 2018-04-12

Brief 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).

Detailed Description

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.

Conditions

Leptospirosis

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Imaxio

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Maryse Beder, MD

Role: PRINCIPAL_INVESTIGATOR

SIAAP

Simonetta Viviani, MD

Role: STUDY_DIRECTOR

Imaxio

Locations

SIAAP

Maisons-Laffitte, , France

Mairie de Paris

Paris, , France

Countries

France

Other Identifiers

2017-A01797-46

Identifier Type: -

Identifier Source: org_study_id