Comparison of Serological Test s for the Virus Chicken Pox Virus (VZV) and Correlation With the Patient's Memory of the Infection or Vaccination (VARI-IMM)

August 21, 2020 updated by: Hopital Foch

Comparison of Serological Tests for the Varicella-zoster Virus and Correlation With the Memory of the Infection or Vaccination

Comparison of the sensibility and specificity of 3 different serological tests and evaluation of chicken pox immunity in pregnant women.

Secondary goals :

  • Correlation memory / Immunity;
  • Prevalence of VZV immunity in pregnant women;
  • Evaluation of cellular and humoral immunity in cases with discrepancy between tests or between test and memory;
  • Evaluation of acceptability of vaccination in the post partum period in non immune patients.

Methods Not randomized prospective study,

Number of patients : 400 Duration : 36 months Inclusion criteria : pregnant women >18years old, agree to participate (written consent) Exclusion criteria: auto immune disease, HIV +, grafted patients

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

308

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Suresnes, France, 92150
        • Hopital Foch

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Pregnant women aged over 18
  • Affiliated to a social protection scheme or women benefiting from such a regime
  • Women who gived a writing consent

Exclusion Criteria:

  • Women with a maternal disease: autoimmune disease (systemic lupus erythematosus, antiphospholipid syndrome, insulin dependent diabetes, autoimmune thyroiditis ..), it takes an immunosuppressive treatment or not.
  • HIV-positive women
  • Garfted women whatever organ

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Pregnant women
Biological: Serological Test s for the Virus Chicken Pox Virus

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rate sensitivity and specificity in negative and dubious zone for the assessment of the serology of anti VZV immunity
Time Frame: 35 weeks
35 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
frequency of immunity detecting depending on whether the patient remember having varicella, have been in contact with next of kin with varicella or been vaccinated against varicella or not
Time Frame: up to 35 weeks
up to 35 weeks
Percentage of women accepting the vaccination in case of negative history
Time Frame: day during the first visit
day during the first visit

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hopital Foch

Investigators

  • Principal Investigator: Olivier Picone, MD, Service Gynécologie Hopital Foch

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

March 30, 2015

Primary Completion (ACTUAL)

July 26, 2020

Study Completion (ACTUAL)

July 26, 2020

Study Registration Dates

First Submitted

May 12, 2016

First Submitted That Met QC Criteria

May 16, 2016

First Posted (ESTIMATE)

May 17, 2016

Study Record Updates

Last Update Posted (ACTUAL)

August 25, 2020

Last Update Submitted That Met QC Criteria

August 21, 2020

Last Verified

August 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/08
  • 2014-A00707-40 (OTHER: ANSM)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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