Clinical trial NCT03497572: Seroprevalence Study to Evaluate the Persistence of Anti-leptospira Antibody in Subjects Vaccinated With Spirolept® Vaccine
Official title: Seroprevalence, Multi-center, Phase IV Cross-sectional Study to Evaluate the Persistence of Anti-leptospira Antibody in Subjects Vaccinated With Spirolept® Vaccine
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Leptospirosis
Keywords: Leptospirosis
Lead sponsor: Imaxio
Sponsor class: INDUSTRY
First posted: 2018-04-13
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: CROSS_SECTIONAL
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).

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.

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

Primary outcomes:
measure: ELISA immunoglobulin G (IgG) anti-leptospire
timeFrame: through study completion, an average of 8 months
Secondary outcomes:
measure: ELISA IgG geometric mean titer (GMTs)
timeFrame: through study completion, an average of 8 months
Other outcomes:
measure: exploratory growth inhibition test (GIT) Test
timeFrame: through study completion, an average of 8 months
Locations:
city: Maisons-Laffitte
country: France
facility: SIAAP
city: Paris
country: France
facility: Mairie de Paris
Study officials:
affiliation: SIAAP
name: Maryse Beder, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Imaxio
name: Simonetta Viviani, MD
role: STUDY_DIRECTOR
References: