Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
NCT ID: NCT01251744
Last Updated: 2020-06-29
Study Results
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View full resultsBasic Information
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COMPLETED
NA
160 participants
INTERVENTIONAL
2010-12-09
2015-06-17
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
OTHER
NONE
Study Groups
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CMV Mothers' Group
Pregnant subjects with confirmed primary CMV infection.
Blood sample
Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Cord blood sample
Cord blood sample taken at the time of delivery.
Saliva swab
Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Urine sampling
Approximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Vaginal swab
Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.
CMV Newborns' Group
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
Blood sample
Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Cord blood sample
Cord blood sample taken at the time of delivery.
Saliva swab
Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Urine sampling
Approximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Vaginal swab
Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.
Interventions
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Blood sample
Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Cord blood sample
Cord blood sample taken at the time of delivery.
Saliva swab
Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Urine sampling
Approximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Vaginal swab
Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.
Eligibility Criteria
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Inclusion Criteria
* A pregnant female, 18 years of age or older at the time of study enrolment.
* Women with confirmed primary CMV infection.
* Written informed consent obtained from the subject.
Exclusion Criteria
* Concurrently participating in another clinical study, at any time during the study period, in which the subject has been or will be exposed to an investigational or a non-investigational pharmaceutical product.
* Previous vaccination against CMV infection.
* Any confirmed or suspected immunosuppressive or immunodeficient condition, based on medical history or physical examination
* Major congenital defects, serious chronic illness or organ transplantation.
* Administration of immunoglobulins and/or any blood products within the three months preceding study enrolment or during the pregnancy.
* Documented Human immunodeficiency virus (HIV)-positive subject.
* Gestational age of more than 34 weeks, as determined by foetal ultrasound.
18 Years
FEMALE
No
Sponsors
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GlaxoSmithKline
INDUSTRY
Responsible Party
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Principal Investigators
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GSK Clinical Trials
Role: STUDY_DIRECTOR
GlaxoSmithKline
Locations
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GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Brussels, , Belgium
GSK Investigational Site
Charleroi, , Belgium
GSK Investigational Site
La Louvière, , Belgium
GSK Investigational Site
Leuven, , Belgium
GSK Investigational Site
Liège, , Belgium
GSK Investigational Site
Mons, , Belgium
GSK Investigational Site
Wilrijk, , Belgium
Countries
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References
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Marchant A, Adali S, Alsdurf H, Bol V, Capelle X, De Schrevel N, Delroisse JM, Devlieger R, Dieussaert I, Donner C, Janssens M, Loquet P, Panackal AA, Seidl C, van den Berg RA, Paris R. Establishing Correlates of Maternal-Fetal Cytomegalovirus Transmission-One Step Closer Through Predictive Modeling. J Infect Dis. 2024 Dec 16;230(6):e1274-e1286. doi: 10.1093/infdis/jiae281.
Antoine P, Olislagers V, Huygens A, Lecomte S, Liesnard C, Donner C, Marchant A. Functional exhaustion of CD4+ T lymphocytes during primary cytomegalovirus infection. J Immunol. 2012 Sep 1;189(5):2665-72. doi: 10.4049/jimmunol.1101165. Epub 2012 Aug 3.
Other Identifiers
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113134
Identifier Type: -
Identifier Source: org_study_id
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