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

Sponsor
Hopital Foch (Other)
Overall Status
Terminated
CT.gov ID
NCT02775422
Collaborator
(none)
308
Enrollment
1
Location
1
Arm
63.9
Actual Duration (Months)
4.8
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Biological: Serological Test s for the Virus Chicken Pox Virus
 N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
308 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Diagnostic
Official Title:
Comparison of Serological Tests for the Varicella-zoster Virus and Correlation With the Memory of the Infection or Vaccination
Actual Study Start Date :
Mar 30, 2015
Actual Primary Completion Date :
Jul 26, 2020
Actual Study Completion Date :
Jul 26, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: Pregnant women

Pregnant women

Biological: Serological Test s for the Virus Chicken Pox Virus

Outcome Measures

Primary Outcome Measures

  1. Rate sensitivity and specificity in negative and dubious zone for the assessment of the serology of anti VZV immunity [35 weeks]

Secondary Outcome Measures

  1. 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 [up to 35 weeks]

  2. Percentage of women accepting the vaccination in case of negative history [day during the first visit]

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 Hopital Foch Suresnes France 92150

Sponsors and Collaborators

  • Hopital Foch

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Hopital Foch
ClinicalTrials.gov Identifier:
NCT02775422
Other Study ID Numbers:
  • 2014/08
  • 2014-A00707-40
First Posted:
May 17, 2016
Last Update Posted:
Aug 25, 2020
Last Verified:
Aug 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Additional relevant MeSH terms:
Infections

Study Results

No Results Posted as of Aug 25, 2020