Back to resultsStudy of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
Primary Purpose
Infections, Cytomegalovirus, Cytomegalovirus Infections
Status
Completed
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Blood sample
Cord blood sample
Saliva swab
Urine sampling
Vaginal swab
Sponsored by
About this trial
This is an interventional other trial for Infections, Cytomegalovirus focused on measuring Pregnancy, Congenital, Cytomegalovirus infection
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
- GSK Investigational Site
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
CMV Mothers' Group
CMV Newborns' Group
Arm Description
Pregnant subjects with confirmed primary CMV infection.
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
Outcomes
Primary Outcome Measures
Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection
The CMV congenital infections were assessed in newborns and foetuses of subjects who had a confirmed primary CMV infection during pregnancy.
Number of Subjects With CMV Presence in the Urine
Evidence of infection in urine was assessed by culture or by Polymerase Chain Reaction (PCR).
Number of Subjects With CMV Presence in the Amniotic Fluid
Evidence of infection in the amniotic fluid was assessed by culture or by Polymerase Chain Reaction (PCR).
Evidence of CMV DNA or CMV Inclusions in Tissues of an Aborted or Stillborn Foetus
Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions
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 CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions
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.
Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status
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 IgM Status
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-Cytomegalovirus (Anti-CMV) Immunoglobulin Type M (IgM) Status
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 Immunoglobulin Type M (IgM) Status, Descriptive Statistics
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects.
Descriptive Statistics for the Anti-CMV IgM Status
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-glycoprotein B (gB) Immunoglobulin Type G (IgG) Antibody Concentrations
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 greater than or equal to (≥) 54 EU/mL.
Anti-gB IgG Antibody Concentrations
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 greater than or equal to (≥) 54 EU/mL.
Descriptive Statistics of the Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Avidity Index
The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Descriptive Statistics of the Anti-gB IgG Avidity Index
The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
CMV-specific Cluster of Differentiation 4 (CD4) T-cell Frequencies
Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among: cluster of differentiation 40 ligand (CD40L), interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among Human Cytomegalovirus [HCMV] immediate-early gene [IE1] antigen, HCMV glicoprotein B [gB] antigen, HCMV lysate antigen and HCMV pp65 antigen).
CMV-specific CD4 T-cell Frequencies
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
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 CD8 T-cell Frequencies
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 Cluster of Differentiation (CD4) T Cells Frequencies
Labelled cells were quantified by flow cytometry, 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
Labelled cells were quantified by flow cytometry, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
Note: Results were retrieved by subtracting the background without imputing the negative and zero values, this generated negative values.
Concentrations of Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Concentrations of Anti-CMV Tegument Protein IgG Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Anti-CMV Tegument Protein IgG Antibody Concentrations
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Concentrations of Anti-CMV IgG Antibodies
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Descriptive Statistics of the Anti-CMV Tegument Protein gB Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Descriptive Statistics of the Anti-CMV Tegument Protein gB IgG Avidity, by Congenital Infection Status
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) IgG Avidity, by Congenital Infection Status
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity Descriptive Statistics, by Congenital Infection Status
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01251744
Brief Title
Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
Official Title
Study of Maternal-foetal Cytomegalovirus (CMV) Transmission
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Completed
Study Start Date
December 9, 2010 (Actual)
Primary Completion Date
November 6, 2013 (Actual)
Study Completion Date
June 17, 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infections, Cytomegalovirus, Cytomegalovirus Infections
Keywords
Pregnancy, Congenital, Cytomegalovirus infection
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
160 (Actual)
8. Arms, Groups, and Interventions
Arm Title
CMV Mothers' Group
Arm Type
Experimental
Arm Description
Pregnant subjects with confirmed primary CMV infection.
Arm Title
CMV Newborns' Group
Arm Type
Experimental
Arm Description
Offsprings of the CMV Mothers' Group, also tested for CMV infection, comprising infants that were live born.
Intervention Type
Procedure
Intervention Name(s)
Blood sample
Intervention Description
Blood sample at study entry, every two months during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Intervention Type
Procedure
Intervention Name(s)
Cord blood sample
Intervention Description
Cord blood sample taken at the time of delivery.
Intervention Type
Procedure
Intervention Name(s)
Saliva swab
Intervention Description
Saliva swab taken at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Intervention Type
Procedure
Intervention Name(s)
Urine sampling
Intervention Description
Approximately 10 mL of urine will be sampled at study entry, every month during pregnancy, at pregnancy conclusion and one month after pregnancy conclusion.
Intervention Type
Procedure
Intervention Name(s)
Vaginal swab
Intervention Description
Vaginal swab taken at study entry, every month during pregnancy and one month after pregnancy conclusion.
Primary Outcome Measure Information:
Title
Number of Subjects With Any Cytomegalovirus (CMV) Congenital Infection
Description
The CMV congenital infections were assessed in newborns and foetuses of subjects who had a confirmed primary CMV infection during pregnancy.
Time Frame
At Month 0
Title
Number of Subjects With CMV Presence in the Urine
Description
Evidence of infection in urine was assessed by culture or by Polymerase Chain Reaction (PCR).
Time Frame
Within 10 days post-delivery (Days 0-9)
Title
Number of Subjects With CMV Presence in the Amniotic Fluid
Description
Evidence of infection in the amniotic fluid was assessed by culture or by Polymerase Chain Reaction (PCR).
Time Frame
Within 10 days post-delivery (Days 0-9)
Title
Evidence of CMV DNA or CMV Inclusions in Tissues of an Aborted or Stillborn Foetus
Time Frame
Within 10 days post-delivery (Days 0-9)
Title
Number of CMV DNA Copies in Saliva, Urine, Blood or Vaginal Secretions
Description
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.
Time Frame
At Month 0
Title
Number of CMV DNA Copies in Saliva, in Urine and in Blood or Vaginal Secretions
Description
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.
Time Frame
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Title
Descriptive Statistics of the Anti-CMV Immunoglobulin Type M (IgM) Status
Description
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.
Time Frame
At Month 0
Title
Descriptive Statistics of the Anti-CMV IgM Status
Description
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.
Time Frame
At Month 2
Title
Descriptive Statistics of the Anti-Cytomegalovirus (Anti-CMV) Immunoglobulin Type M (IgM) Status
Description
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.
Time Frame
At Month 4
Title
Anti-CMV Immunoglobulin Type M (IgM) Status, Descriptive Statistics
Description
Anti-CMV IgM status was assessed by Enzyme-Linked Immunosorbent Assay [ELISA], with respect to positive and negative subjects.
Time Frame
At Month 6
Title
Descriptive Statistics for the Anti-CMV IgM Status
Description
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.
Time Frame
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Title
Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Antibody Concentrations
Description
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 greater than or equal to (≥) 54 EU/mL.
Time Frame
At Month 0
Title
Anti-gB IgG Antibody Concentrations
Description
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 greater than or equal to (≥) 54 EU/mL.
Time Frame
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Title
Descriptive Statistics of the Anti-glycoprotein B (gB) Immunoglobulin Type G (IgG) Avidity Index
Description
The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame
At Month 0
Title
Descriptive Statistics of the Anti-gB IgG Avidity Index
Description
The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Title
CMV-specific Cluster of Differentiation 4 (CD4) T-cell Frequencies
Description
Descriptive statistics of the frequency of CMV-specific CD4 T cells expressing at least two markers among: cluster of differentiation 40 ligand (CD40L), interleukin-2 (IL-2), interferon-gamma (IFN-γ), tumor necrosis factor-alpha (TNF-α), as assessed by Intracellular Cytokine Staining [ICS], by stimulating agent (among Human Cytomegalovirus [HCMV] immediate-early gene [IE1] antigen, HCMV glicoprotein B [gB] antigen, HCMV lysate antigen and HCMV pp65 antigen).
Time Frame
At Month 0
Title
CMV-specific CD4 T-cell Frequencies
Description
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).
Time Frame
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Title
CMV-specific Cluster of Differentiation 8 (CD8) T-cell Frequencies
Description
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).
Time Frame
At Month 0
Title
CMV-specific CD8 T-cell Frequencies
Description
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).
Time Frame
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Title
CMV-specific Proliferating Cluster of Differentiation (CD4) T Cells Frequencies
Description
Labelled cells were quantified by flow cytometry, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
Time Frame
At Month 0
Title
CMV-specific Proliferating CD4 T Cells Frequencies
Description
Labelled cells were quantified by flow cytometry, by stimulating agent (among immediate-early gene [IE1] antigen, glicoprotein B [gB] antigen, CMV lysate antigen and CMV pp65 antigen).
Note: Results were retrieved by subtracting the background without imputing the negative and zero values, this generated negative values.
Time Frame
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Title
Concentrations of Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibodies
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Time Frame
At Day 0 = study entry
Title
Anti-CMV Tegument Protein Immunoglobulin G (IgG) Antibody Concentrations
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Time Frame
At Month 2
Title
Concentrations of Anti-CMV Tegument Protein IgG Antibodies
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Time Frame
At Month 4
Title
Anti-CMV Tegument Protein IgG Antibody Concentrations
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Time Frame
At Month 6
Title
Concentrations of Anti-CMV IgG Antibodies
Description
Antibody concentrations were expressed as Geometric Mean Concentrations (GMCs), measured in units per milliliter (U/mL). Concentrations of antibodies were assessed by the Enzyme-Linked Immunosorbent Assay (ELISA) for a cut-off greater than or equal to (≥) 0.668 U/mL.
Time Frame
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Title
Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
Description
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame
At Day 0 = study entry
Title
Descriptive Statistics of the Anti-CMV Tegument Protein gB Immunoglobulin G (IgG) Avidity, by Congenital Infection Status
Description
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame
At Month 2
Title
Descriptive Statistics of the Anti-CMV Tegument Protein gB IgG Avidity, by Congenital Infection Status
Description
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame
At Month 4
Title
Descriptive Statistics of the Anti-CMV Tegument Protein Globulin Type B (gB) IgG Avidity, by Congenital Infection Status
Description
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame
At Month 6
Title
Anti-CMV Tegument Protein Globulin Type B (gB) Immunoglobulin G (IgG) Avidity Descriptive Statistics, by Congenital Infection Status
Description
Avidity of anti-CMV tegument protein gB IgG was assessed by ELISA. The avidity index was calculated as the mean absorbance of reactions in which the immune complexes were exposed to urea divided by the mean absorbance of reactions in which the immune complexes were not exposed to urea, expressed as a percentage.
Time Frame
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Title
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Description
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Time Frame
At Month 0
Title
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Description
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Time Frame
At Month 2
Title
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Description
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Time Frame
At Month 4
Title
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Description
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Time Frame
At Month 6
Title
Anti-CMV Antibody Titers, by Neutralisation Assay (Fibroblast)
Description
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Time Frame
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
Title
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Description
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Time Frame
At Month 0
Title
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Description
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Time Frame
At Month 2
Title
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Description
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Time Frame
At Month 4
Title
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Description
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 15 ED50.
Time Frame
At Month 6
Title
Anti-CMV Antibody Titers, by Neutralisation Assay (Epithelial Cells)
Description
Antibody titers were expressed as Geometric Mean Titers (GMTs), for the seropositivity cut-off of ≥ 10 ED50.
Time Frame
At pregnancy conclusion (Day 0 to 5, Day 0 = day of delivery, stillbirth or termination)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Brussels
ZIP/Postal Code
1000
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1050
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1070
Country
Belgium
Facility Name
GSK Investigational Site
City
Charleroi
ZIP/Postal Code
6000
Country
Belgium
Facility Name
GSK Investigational Site
City
La Louvière
ZIP/Postal Code
7100
Country
Belgium
Facility Name
GSK Investigational Site
City
Leuven
ZIP/Postal Code
3000
Country
Belgium
Facility Name
GSK Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Mons
ZIP/Postal Code
7000
Country
Belgium
Facility Name
GSK Investigational Site
City
Wilrijk
ZIP/Postal Code
2610
Country
Belgium
12. IPD Sharing Statement
Citations:
PubMed Identifier
22865914
Citation
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.
Results Reference
derived
Learn more about this trial
Study of the Transmission of Cytomegalovirus (CMV) Infection From Mother to Foetus
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