Comparison of Serological Test s for the Virus Chicken Pox Virus (VZV) and Correlation With the Patient's Memory of the Infection or Vaccination
NCT ID: NCT02775422
Last Updated: 2020-08-25
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
TERMINATED
Clinical Phase
NA
Total Enrollment
308 participants
Study Classification
INTERVENTIONAL
Study Start Date
2015-03-30
Study Completion Date
2020-07-26
Brief Summary
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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
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
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Detailed Description
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Conditions
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Pregnancy
Study Design
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Allocation Method
NA
Intervention Model
SINGLE_GROUP
Primary Study Purpose
DIAGNOSTIC
Blinding Strategy
NONE
Study Groups
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Pregnant women
Pregnant women
Group Type
EXPERIMENTAL
Serological Test s for the Virus Chicken Pox Virus
Intervention Type
BIOLOGICAL
Interventions
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Serological Test s for the Virus Chicken Pox Virus
Intervention Type
BIOLOGICAL
Eligibility Criteria
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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
* 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
* HIV-positive women
* Garfted women whatever organ
Minimum Eligible Age
18 Years
Eligible Sex
FEMALE
Accepts Healthy Volunteers
No
Sponsors
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Hopital Foch
OTHER
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Olivier Picone, MD
Role: PRINCIPAL_INVESTIGATOR
Service Gynécologie Hopital Foch
Locations
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Hopital Foch
Suresnes, , France
Site Status
Countries
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France
References
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LAFORET EG, LYNCH CL Jr. Multiple congenital defects following maternal varicella; report of a case. N Engl J Med. 1947 Apr 10;236(15):534-7. doi: 10.1056/NEJM194704102361504. No abstract available.
Reference Type
BACKGROUND
Alkalay AL, Pomerance JJ, Rimoin DL. Fetal varicella syndrome. J Pediatr. 1987 Sep;111(3):320-3. doi: 10.1016/s0022-3476(87)80447-x. No abstract available.
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BACKGROUND
SAUERBREI A. Fetales varizellen syndrom. Monatsschr kinderheiledkd 2003;151:209-213.
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Miller E, Cradock-Watson JE, Ridehalgh MK. Outcome in newborn babies given anti-varicella-zoster immunoglobulin after perinatal maternal infection with varicella-zoster virus. Lancet. 1989 Aug 12;2(8659):371-3. doi: 10.1016/s0140-6736(89)90547-3.
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BACKGROUND
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.
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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.
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Reignier F, Romano L, Thiry N, Beutels P, Van Damme P, Fau C, Gaspard C, Mamoux V, Zanetti A, Floret D. [Varicella-zoster virus seroprevalence in nursery and day-care workers in Lyon (France)]. Med Mal Infect. 2005 Apr;35(4):192-6. doi: 10.1016/j.medmal.2005.01.007. French.
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Pourahmad M, Davami MH, Jahromi AR. Evaluation of anti-varicella antibody in young women before their marriage: A sero-epidemiologic study in Iran. J Clin Virol. 2010 Aug;48(4):260-3. doi: 10.1016/j.jcv.2010.04.015. Epub 2010 Jun 9.
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BACKGROUND
Perella D, Fiks AG, Jumaan A, Robinson D, Gargiullo P, Pletcher J, Forke CM, Schmid DS, Renwick M, Mankodi F, Watson B, Spain CV. Validity of reported varicella history as a marker for varicella zoster virus immunity among unvaccinated children, adolescents, and young adults in the post-vaccine licensure era. Pediatrics. 2009 May;123(5):e820-8. doi: 10.1542/peds.2008-3310.
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Reference Type
BACKGROUND
Enders G, Miller E, Cradock-Watson J, Bolley I, Ridehalgh M. Consequences of varicella and herpes zoster in pregnancy: prospective study of 1739 cases. Lancet. 1994 Jun 18;343(8912):1548-51. doi: 10.1016/s0140-6736(94)92943-2.
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Breuer J, Schmid DS, Gershon AA. Use and limitations of varicella-zoster virus-specific serological testing to evaluate breakthrough disease in vaccinees and to screen for susceptibility to varicella. J Infect Dis. 2008 Mar 1;197 Suppl 2:S147-51. doi: 10.1086/529448.
Reference Type
BACKGROUND
Maple PA, Rathod P, Smit E, Gray J, Brown D, Boxall EH. Comparison of the performance of the LIAISON VZV-IgG and VIDAS automated enzyme linked fluorescent immunoassays with reference to a VZV-IgG time-resolved fluorescence immunoassay and implications of choice of cut-off for LIAISON assay. J Clin Virol. 2009 Jan;44(1):9-14. doi: 10.1016/j.jcv.2008.08.012. Epub 2008 Sep 27.
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BACKGROUND
Sauerbrei A, Schafler A, Hofmann J, Schacke M, Gruhn B, Wutzler P. Evaluation of three commercial varicella-zoster virus IgG enzyme-linked immunosorbent assays in comparison to the fluorescent-antibody-to-membrane-antigen test. Clin Vaccine Immunol. 2012 Aug;19(8):1261-8. doi: 10.1128/CVI.00183-12. Epub 2012 Jun 20.
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Tischer A, Gassner M, Richard JL, Suter-Riniker F, Mankertz A, Heininger U. Vaccinated students with negative enzyme immunoassay results show positive measles virus-specific antibody levels by immunofluorescence and plaque neutralisation tests. J Clin Virol. 2007 Mar;38(3):204-9. doi: 10.1016/j.jcv.2006.12.017. Epub 2007 Feb 7.
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Seward JF, Watson BM, Peterson CL, Mascola L, Pelosi JW, Zhang JX, Maupin TJ, Goldman GS, Tabony LJ, Brodovicz KG, Jumaan AO, Wharton M. Varicella disease after introduction of varicella vaccine in the United States, 1995-2000. JAMA. 2002 Feb 6;287(5):606-11. doi: 10.1001/jama.287.5.606.
Reference Type
BACKGROUND
Other Identifiers
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2014-A00707-40
Identifier Type: OTHER
Identifier Source: secondary_id
2014/08
Identifier Type: -
Identifier Source: org_study_id
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