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

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

Status

Terminated

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02775422

Acronym

VARI-IMM

Enrollment

308

Registered

2016-05-17

Start date

2015-03-30

Completion date

2020-07-26

Last updated

2020-08-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pregnancy

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

Interventions

BIOLOGICALSerological Test s for the Virus Chicken Pox Virus

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

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

Secondary

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	up to 35 weeks
Percentage of women accepting the vaccination in case of negative history	day during the first visit

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026