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

Leptospirosis Clinical Trial

— SPT-001  

Official title:

Seroprevalence, Multi-center, Phase IV Cross-sectional Study to Evaluate the Persistence of Anti-leptospira Antibody in Subjects Vaccinated With Spirolept® Vaccine

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03497572
• Other study ID #: 2017-A01797-46
• Status: Completed
• Start date: August 25, 2017
• Est. completion date: April 12, 2018

Study information

• Verified date: May 2018
• Source: Imaxio
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Leptospirosis

Locations

Country	Name	City	State
France	SIAAP	Maisons-Laffitte
France	Mairie de Paris	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Imaxio

Country where clinical trial is conducted

France, 

Outcome

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