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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)

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ClinicalTrials.gov Identifier: NCT02775422
Recruitment Status : Recruiting
First Posted : May 17, 2016
Last Update Posted : February 1, 2017
Sponsor:
Information provided by (Responsible Party):
Hopital Foch

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
Pregnancy Biological: Serological Test s for the Virus Chicken Pox Virus Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 400 participants
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
Study Start Date : March 2015
Estimated Primary Completion Date : February 2018
Estimated Study Completion Date : February 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Pregnant women
Pregnant women
Biological: Serological Test s for the Virus Chicken Pox Virus



Primary Outcome Measures :
  1. Rate sensitivity and specificity in negative and dubious zone for the assessment of the serology of anti VZV immunity [ Time Frame: 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 [ Time Frame: up to 35 weeks ]
  2. Percentage of women accepting the vaccination in case of negative history [ Time Frame: day during the first visit ]


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02775422


Contacts
Contact: Olivier Picone, MD +33(0)146252974 o.picone@hopital-foch.org

Locations
France
Hopital Foch Recruiting
Suresnes, France, 92150
Contact: Olivier Picone, MD    +33(0)146252974    o.picone@hopital-foch.org   
Sponsors and Collaborators
Hopital Foch
Investigators
Principal Investigator: Olivier Picone, MD Service Gynécologie Hopital Foch

Publications:
SAUERBREI A. Fetales varizellen syndrom. Monatsschr kinderheiledkd 2003;151:209-213.
ENDERS G. Varicella and herpes zoster in pregnancy and the newborn. . Varicella-zoster virus and clinical management. Arvin AM and Gershon AA, eds; UK: Cambridge University Press 2000:317-347.
MIRLESSE V. Varicelle et grossesse. Les virus transmissibles de la mère à l'enfant. Denis F. Ed John Libey Eurotext, In Montrouge 1999:252-269.

Responsible Party: Hopital Foch
ClinicalTrials.gov Identifier: NCT02775422     History of Changes
Other Study ID Numbers: 2014/08
2014-A00707-40 ( Other Identifier: ANSM )
First Posted: May 17, 2016    Key Record Dates
Last Update Posted: February 1, 2017
Last Verified: January 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No