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

Pregnancy Clinical Trial

— VARI-IMM  

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02775422
• Other study ID #: 2014/08
• Secondary ID: 2014-A00707-40
• Status: Terminated
• Phase: N/A
• Start date: March 30, 2015
• Est. completion date: July 26, 2020

Study information

• Verified date: August 2019
• Source: Hopital Foch
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 308
• Est. completion date: July 26, 2020
• Est. primary completion date: July 26, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Infection
• Pregnancy

Intervention

Biological:
• Serological Test s for the Virus Chicken Pox Virus

Locations

Country	Name	City	State
France	Hopital Foch	Suresnes

Sponsors (1)

Lead Sponsor	Collaborator
Hopital Foch

Country where clinical trial is conducted

France, 

References & Publications (25)

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* Note: There are 25 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rate sensitivity and specificity in negative and dubious zone for the assessment of the serology of anti VZV immunity		35 weeks
Secondary	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
Secondary	Percentage of women accepting the vaccination in case of negative history		day during the first visit