Seroprevalence Study to Evaluate the Persistence of Anti-leptospira Antibody in Subjects Vaccinated With Spirolept® Vaccine (SPT-001)

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

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).

Study Overview

• Status: Completed
• Conditions: Leptospirosis

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.

• Study Type: Observational
• Enrollment (Actual): 145

Contacts and Locations

Study Locations

• France
  • Maisons-Laffitte, France, 78603
    • SIAAP
  • Paris, France, 75013
    • Mairie de Paris

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

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).

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Imaxio
• Investigators: Principal Investigator: Maryse Beder, MD, SIAAP; Study Director: Simonetta Viviani, MD, Imaxio

Study record dates

Study Major Dates

• Study Start (Actual): August 25, 2017
• Primary Completion (Actual): April 12, 2018
• Study Completion (Actual): April 12, 2018

Study Registration Dates

• First Submitted: August 10, 2017
• First Submitted That Met QC Criteria: April 12, 2018
• First Posted (Actual): April 13, 2018

Study Record Updates

• Last Update Posted (Actual): May 8, 2018
• Last Update Submitted That Met QC Criteria: May 7, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Keywords: Leptospirosis
• Additional Relevant MeSH Terms: Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Spirochaetales Infections; Leptospirosis; Weil Disease
• Other Study ID Numbers: 2017-A01797-46

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No