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

NCT03497572 | Completed

• 1 other identifier: 2017-A01797-46
• Study Type: observational
• Target: 145
• Locations: 1 country
• Sites: 2

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).

Conditions

Leptospirosis

Keywords

Leptospirosis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• ELISA IgG geometric mean titer (GMTs)

  through study completion, an average of 8 months

Other Outcomes (1)

• exploratory growth inhibition test (GIT) Test

  through study completion, an average of 8 months

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Imaxio: lead

Study Sites (2)

SIAAP

Maisons-Laffitte, 78603, France

Location

Mairie de Paris

Paris, 75013, France

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

IgG, GIT are studied on serum

MeSH Terms

Conditions

Leptospirosis

Condition Hierarchy (Ancestors)

Spirochaetales Infections; Gram-Negative Bacterial Infections; Bacterial Infections; Bacterial Infections and Mycoses; Infections

Study Officials

• Maryse Beder, MD

  SIAAP

  PRINCIPAL INVESTIGATOR

• Simonetta Viviani, MD

  Imaxio

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 10, 2017
• First Posted: April 13, 2018
• Study Start: August 25, 2017
• Primary Completion: April 12, 2018
• Study Completion: April 12, 2018
• Last Updated: May 8, 2018

Record last verified: 2018-05

Locations

FR (2)