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Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01251744
First received: November 30, 2010
Last updated: May 26, 2017
Last verified: May 2017
November 30, 2010
May 26, 2017
December 9, 2010
November 6, 2013   (Final data collection date for primary outcome measure)
  • Number of subjects with any CMV congenital infection [ Time Frame: At Day 0 ]
    The CMV congenital infections were assessed in newborns and foetuses of subjects who had a confirmed primary CMV infection during pregnancy.
  • Number of newborns with CMV presence in the urine [ Time Frame: Within 10 days post-delivery (Days 0-9) ]
    Evidence of infection in urine was assessed by culture or by Polymerase Chain Reaction (PCR).
  • Number of newborns with CMV presence in the amniotic fluid [ Time Frame: Within 10 days post-delivery (Days 0-9) ]
    Evidence of infection in the amniotic fluid was assessed by culture or by Polymerase Chain Reaction (PCR).
  • Number of pregnant subjects with evidence of CMV in saliva, urine, blood or vaginal secretions [ Time Frame: At Day 0 ]
    The assessment focused on the presence of CMV DNA copies (by Quantitative Polymerase Chain Reaction [qPCR]) in saliva, urine, blood and vaginal secretions every month from study entry to, and including, pregnancy conclusion.
  • Number of pregnant subjects with evidence of CMV in saliva, urine, blood or vaginal secretions [ Time Frame: At pregnancy conclusion ]
    The assessment focused on the presence of CMV DNA copies (by Quantitative Polymerase Chain Reaction [qPCR]) in saliva, urine and blood every month from study entry to, and including, pregnancy conclusion. No vaginal mucus results were available.
  • Descriptive statistics of the anti-CMV Immunoglobulin type M (IgM) status [ Time Frame: At Day 0 ]
    Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
  • Descriptive statistics of the anti-CMV Immunoglobulin type M (IgM) status [ Time Frame: At Month 2 ]
    Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
  • Descriptive statistics of the anti-CMV Immunoglobulin type M (IgM) status [ Time Frame: At Month 4 ]
    Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
  • Descriptive statistics of the anti-CMV Immunoglobulin type M (IgM) status [ Time Frame: At Month 6 ]
    Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects.
  • Descriptive statistics of the anti-CMV Immunoglobulin type M (IgM) status [ Time Frame: At pregnancy conclusion ]
    Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects. Grey Zone = optical density zone within 20% of cut-off value. When an optical density is within this grey zone, sample testing is repeated to confirm the result.
  • Anti-CMV antibody titers [ Time Frame: Every two months from study entry to, and including, pregnancy conclusion ]
    As assessed by neutralisation assay. At the time of writing this summary, (re)development of CMV micro-neutralization assays is still ongoing. Results will be added when they become available
  • Anti-glycoprotein B (gB) immunoglobulin type G (IgG) antibody concentrations [ Time Frame: At Day 0 ]
    Anti-gB IgG concentrations were assessed by ELISA, presented as geometric mean concentrations and expressed in ELISA units per milliliter (EU/mL). The cut-off value was 54 EU/mL.
  • Anti-glycoprotein B (gB) immunoglobulin type G (IgG) antibody concentrations [ Time Frame: At pregnancy conclusion ]
    Anti-gB IgG concentrations were assessed by ELISA, presented as geometric mean concentrations (GMCs) and expressed in ELISA units per milliliter (EU/mL). The cut-off value was 54 EU/mL.
  • Descriptive statistics of the anti-glycoprotein B (gB) immunoglobulin type G (IgG) avidity index [ Time Frame: At Day 0 ]
    As assessed by ELISA.
  • Descriptive statistics of the anti-glycoprotein B (gB) immunoglobulin type G (IgG) avidity index [ Time Frame: At pregnancy conclusion ]
    As assessed by ELISA.
  • Anti-CMV tegument protein IgG antibody titres [ Time Frame: Every two months from study entry to, and including, pregnancy conclusion ]
    As assessed by ELISA.
  • Anti-CMV tegument protein IgG avidity index [ Time Frame: Every two months from study entry to, and including, pregnancy conclusion ]
    As assessed by ELISA
  • CMV-specific cluster of differentiation 4 (CD4) T-cell frequencies [ Time Frame: At Day 0 ]
    Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
  • CMV-specific cluster of differentiation 4 (CD4) T-cell frequencies [ Time Frame: At pregnancy conclusion ]
    Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
  • CMV-specific cluster of differentiation 8 (CD8) T-cell frequencies [ Time Frame: At Day 0 ]
    Descriptive statistics of the frequency of CMV-specific CD8 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
  • CMV-specific cluster of differentiation 8 (CD8) T-cell frequencies [ Time Frame: At pregnancy conclusion ]
    Descriptive statistics of the frequency of CMV-specific CD8 T cells expressing at least two markers among CD40L, IL-2, IFNg, TNFa, as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
  • CMV-specific proliferating CD4 T cells frequencies [ Time Frame: At Day 0 ]
    As assessed by ICS, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
  • CMV-specific proliferating CD4 T cells frequencies [ Time Frame: At pregnancy conclusion ]
    As assessed by ICS, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen)
  • Occurrence of congenital CMV infection in newborns or foetuses of subjects who had a confirmed primary CMV infection during pregnancy. [ Time Frame: During pregnancy and at pregnancy conclusion. ]
  • Evidence of CMV in saliva, urine, blood or vaginal secretions of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints. [ Time Frame: Every month (saliva, urine, vaginal secretions) and every two months (blood) from study entry to, and including (except for vaginal secretions), pregnancy conclusion. ]
  • Assessment of antibody responses to CMV of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints. [ Time Frame: Every two months from study entry to, and including, pregnancy conclusion. ]
  • Assessment of the cell-mediated immune responses of pregnant subjects with a confirmed primary CMV infection at protocol-defined timepoints. [ Time Frame: Every two months from study entry to, and including, pregnancy conclusion. ]
Complete list of historical versions of study NCT01251744 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
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Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
Study of Maternal-foetal Cytomegalovirus (CMV) Transmission
This study is designed to evaluate maternal virological and immunological parameters to determine their ability to predict congenital cytomegalovirus (CMV) infection. When a pregnant woman is infected with CMV, her immune system (which protects her from infection) is activated and the virus can be found in the woman's bodily fluids (blood, saliva, urine, vaginal secretions). The aim of this study is to find out if there is a link between either the pregnant woman's immune response or the presence of the virus in these bodily fluids and the child/foetus being infected with the virus.
Not Provided
Interventional
Not Provided
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Infections, Cytomegalovirus
  • Procedure: Blood sample
    Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
  • Procedure: Cord blood sample
    Cord blood sample taken at the time of delivery.
  • Procedure: Saliva swab
    Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
  • Procedure: 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.
  • Procedure: Vaginal swab
    Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.
  • Experimental: CMV Mothers' Group
    Pregnant subjects with confirmed primary CMV infection.
    Interventions:
    • Procedure: Blood sample
    • Procedure: Cord blood sample
    • Procedure: Saliva swab
    • Procedure: Urine sampling
    • Procedure: Vaginal swab
  • Experimental: CMV Infant Group
    Offspring of the CMV Mothers' Group, also tested for CMV infection.
    Interventions:
    • Procedure: Blood sample
    • Procedure: Cord blood sample
    • Procedure: Saliva swab
    • Procedure: Urine sampling
    • Procedure: Vaginal swab
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
159
June 17, 2015
November 6, 2013   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • Subjects who the investigator believes that they can and will comply with the requirements of the protocol .
  • 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:

  • Chronic administration of immunosuppressants or other immune-modifying drugs within six months prior to study entry.
  • 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.
Sexes Eligible for Study: Female
18 Years and older   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Belgium
 
 
NCT01251744
113134
Not Provided
Not Provided
Not Provided
GlaxoSmithKline
GlaxoSmithKline
Not Provided
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
May 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP